TY - JOUR AU - Staiano, Walter AU - Callahan, Christine AU - Davis, Michelle AU - Tanner, Leah AU - Coe, Chelsea AU - Kunkle, Sarah AU - Kirk, Ulrich PY - 2025/4/23 TI - Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e68665 VL - 13 KW - cognitive behavioral therapy for insomnia KW - mindfulness KW - randomized controlled trial KW - RCT KW - therapy KW - insomnia KW - behavioral KW - app based KW - app N2 - Background: Insomnia is the most commonly reported sleep disturbance and significantly impacts mental health and quality of life. Traditional treatments for insomnia include pharmacological interventions or cognitive behavioral therapy for insomnia (CBT-I), but these options may not be accessible to everyone who needs treatment. Objective: This study aims to assess the effectiveness of the app-based Headspace Sleep Program in adults with clinical insomnia on sleep disturbance and mental health outcomes, compared with a waitlist control group. Methods: This randomized controlled trial included 132 adults with clinical insomnia who were assigned to either the Headspace Sleep Program (an 18-session self-guided, in-app program utilizing CBT-I techniques augmented by mindfulness) or a waitlist control group. Sleep disturbance outcomes were assessed by changes in insomnia symptoms (measured using the Insomnia Severity Index) and sleep efficiency (measured via sleep diary and actigraphy). Mental health outcomes included perceived stress (measured by the 10-item Perceived Stress Scale), depressive symptoms (measured by the 8-item Patient Health Questionnaire), sleep quality (measured by the Pittsburgh Sleep Quality Index), anxiety symptoms (measured by the 7-item Generalized Anxiety Disorder Scale), and mindfulness (measured by the Mindful Attention Awareness Scale). Changes from baseline to postintervention and follow-up were assessed for each outcome. Results: Participants had a mean (SD) age of 37.2 (10.6) years, with 69 out of 132 (52.3%) identifying as female. Those randomized to the Headspace Sleep Program group experienced significantly greater improvements in insomnia symptoms from baseline to postintervention and follow-up compared with participants in the waitlist control group (P<.001, ?²p=0.107). Improvements from baseline to postintervention and follow-up were also observed in the Headspace Sleep Program group for sleep efficiency, as measured by both sleep diary (P=.01, ?²p=.03) and actigraphy outcomes (P=.01, ?²p=.03). Participants in the Headspace Sleep Program group showed greater improvements in insomnia remission rates (8/66, 12%, at postintervention and 9/66, 14%, at follow-up) and treatment response (11/66, 17%, at postintervention and 15/66, 23%, at follow-up) compared with the control group (remission rate 2/66, 3%, at postintervention and 0/66, 0%, at follow-up; treatment response 3/66, 5%, at postintervention and 1/66, 2%, at follow-up). The results suggest significant improvements in depressive symptoms (P=.01, ?²p=.04), anxiety symptoms (P=.02, ?²p=.02), and mindfulness (P=.01, ?²p=.03) in the Headspace Sleep Program group. Conclusions: The Headspace Sleep Program is an effective intervention for improving sleep disturbances in adults with clinical insomnia. Trial Registration: ClinicalTrials.gov NCT05872672; https://clinicaltrials.gov/ct2/show/NCT05872672 UR - https://mhealth.jmir.org/2025/1/e68665 UR - http://dx.doi.org/10.2196/68665 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/68665 ER - TY - JOUR AU - Treves, Isaac AU - Bajwa, Zia AU - Greene, D. Keara AU - Bloom, A. Paul AU - Kim, Nayoung AU - Wool, Emma AU - Goldberg, B. Simon AU - Whitfield-Gabrieli, Susan AU - Auerbach, P. Randy PY - 2025/4/17 TI - Consumer-Grade Neurofeedback With Mindfulness Meditation: Meta-Analysis JO - J Med Internet Res SP - e68204 VL - 27 KW - neurofeedback KW - mindfulness KW - device KW - neurotechnology KW - meditation KW - stress KW - cognition KW - Muse KW - consumer grade KW - meta-analyses KW - neuroscientific technology KW - neurotechnologies KW - randomized N2 - Background: There is burgeoning interest in the application of neuroscientific technology to facilitate meditation and lead to beneficial psychological outcomes. One popular approach is using consumer-grade neurofeedback devices to deliver feedback on brain targets during meditation (mindfulness-based neurofeedback). It is hypothesized that optimizing brain targets like alpha and theta band activity may allow meditators to experience deeper mindfulness and thus beneficial outcomes. Objective: This study aimed to systematically review and meta-analyze the impacts of consumer-grade mindfulness-based neurofeedback compared with control conditions. Included studies involved mindfulness practice operationalized as open monitoring or focused attention meditation. This study was preregistered. Methods: A total of 16 randomized controlled training trials, as well as 5 randomized within-participant designs were included, encompassing 763 and 167 unique participants, respectively. Effects were categorized outcomes (ie, psychological distress, cognitive function, and physiological health) and process variables (ie, state mindfulness and brain measures). Study risk of bias, reporting bias, and publication bias were assessed. Results: Samples were typically small (n=30-50), and the majority of studies used mindfulness apps as controls. To deliver neurofeedback, most studies used the Muse device (11/16 randomized controlled trials [RCTs]). There was a modest effect for decreases in psychological distress compared with controls (k=11, g=?0.16, P=.03), and heterogeneity was low (I2< 0.25). However, there was no evidence for improvements in cognition (k=7, g=0.07, P=.48), mindfulness (k=9, g=0.02, P=.83), and physiological health (k=7, g=0.11, P=.57) compared to controls. Mechanistic modulation of brain targets was not found in RCTs or within-participant designs. Sex (male or female), age, clinical status, study quality, active or passive controls, sample size, and neurofeedback duration did not moderate effects. There was some evidence for reporting bias, but no evidence of publication bias. Adverse effects were not assessed in 19 out of 21 studies and not found in the 2 studies that assessed them. Conclusions: Assertions that consumer-grade devices can allow participants to modulate their brains and deepen their meditations are not currently supported. It is possible that neurofeedback effects may rely on ?neurosuggestion? (placebo effects of neurotechnology). Future research should examine more extensive calibration and individualization of devices, larger sample sizes, and gold-standard sham-controlled RCTs. UR - https://www.jmir.org/2025/1/e68204 UR - http://dx.doi.org/10.2196/68204 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/68204 ER - TY - JOUR AU - Fleszar-Pavlovic, E. Sara AU - Noriega Esquives, Blanca AU - Lovan, Padideh AU - Brito, E. Arianna AU - Sia, Marie Ann AU - Kauffman, Adelyn Mary AU - Lopes, Maria AU - Moreno, I. Patricia AU - Koru-Sengul, Tulay AU - Gong, Rui AU - Wang, Trent AU - Wieder, D. Eric AU - Rueda-Lara, Maria AU - Antoni, Michael AU - Komanduri, Krishna AU - Lesiuk, Teresa AU - Penedo, J. Frank PY - 2025/4/11 TI - Development of an eHealth Mindfulness-Based Music Therapy Intervention for Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: Qualitative Study JO - JMIR Form Res SP - e65188 VL - 9 KW - allogeneic stem cell transplantation KW - hematologic malignancy KW - bone marrow transplant KW - mindfulness-based music therapy KW - mindfulness KW - music therapy KW - eHealth KW - music therapy intervention KW - adult KW - adolescence KW - allogeneic KW - stem cell transplantation KW - stem cell KW - transplantation KW - qualitative study KW - treatment KW - hematologic cancers KW - psychological distress KW - side effects KW - mindfulness-based stress reduction KW - stress reduction KW - anxiety KW - depression KW - diagnosis KW - blood sample collection KW - eHealth tool KW - quality of life KW - cancer survivors N2 - Background: Allogeneic hematopoietic stem cell transplantation (allo-SCT) is an effective treatment for various hematologic cancers, though it often results in severe side effects and psychological distress, which can negatively impact health outcomes. Integrative therapies like mindfulness-based stress reduction (MBSR), mindfulness meditation (MM), and music therapy (MT) yield promising results in enhancing both psychosocial outcomes (eg, reducing anxiety and depression) and physiological adaptation (eg, decreasing inflammation) in cancer patients. Objective: We developed and refined, using focus groups and environmental and field testing, an eHealth-delivered mindfulness-based music therapy (eMBMT) intervention aimed at improving health-related quality of life, symptom burden (ie, pain, fatigue, and sleep), disease activity (ie, chronic graft-versus-host disease, cytomegalovirus activation, and infections) and psychosocial (ie, depression, anxiety, and cancer-specific distress) and physiological adaptation (ie, inflammation and immune reconstitution) tailored to adults receiving allo-SCT. Methods: eMBMT intervention content is grounded in MT, MM, and MBSR, developed by a multidisciplinary team, and adapted for adults undergoing allo-SCT. eMBMT content was refined through focus groups and usability and field testing. Focus groups used a semistructured interview guide, while field testing used the ?think aloud? method. Usability was evaluated using the 30-item Usefulness, Satisfaction, and Ease of Use (USE) questionnaire. Descriptive statistics analyzed the USE questionnaire and participant characteristics, while rapid qualitative analysis was applied to focus groups and field-testing sessions. Survivors eligible to participate in the focus groups and usability and field testing were adults (>18 years old) who received an allo-SCT (<36 months) for myelodysplastic syndrome, acute myeloid leukemia, or chronic myeloid leukemia, and were in remission for greater than 3 months. Results: During the focus groups, participants (n=11; mean age 43.6, SD 17.8 years) provided qualitative feedback highlighting the shock of diagnosis, challenges during hospitalization, and coping strategies posttreatment. The eMBMT platform received positive evaluations for usefulness (mean 6.47, SD 0.29), ease of use (mean 6.92, SD 0.60), and satisfaction (mean 6.16, SD 0.82). Key themes from field testing highlighted the significance of social support, hope, and maintaining an active lifestyle. Suggestions for improvement included incorporating more representative content, reducing text, enhancing guidance, offering diverse music options, and streamlining blood sample collection. Conclusions: The eMBMT intervention is a comprehensive, user-friendly eHealth tool tailored to the unique needs of allo-SCT patients. The positive feedback and identified areas for improvement underscore its potential to enhance well-being, symptom management, and overall quality of life for cancer survivors. A future pilot randomized controlled trial will further evaluate the feasibility, acceptability, and preliminary efficacy of the eMBMT intervention in improving health-related quality of life, symptom burden, disease activity, and psychosocial and physiological adaptation. Trial Registration: ClinicalTrials.gov NCT05968963; https://clinicaltrials.gov/study/NCT05968963 UR - https://formative.jmir.org/2025/1/e65188 UR - http://dx.doi.org/10.2196/65188 ID - info:doi/10.2196/65188 ER - TY - JOUR AU - Laverdière, Roxanne AU - Jackson, L. Philip AU - Banville, Frédéric PY - 2025/4/9 TI - A New Mobile App to Train Attention Processes in People With Traumatic Brain Injury: Logical and Ecological Content Validation Study JO - JMIR Form Res SP - e64174 VL - 9 KW - mobile app KW - attention training KW - cognitive remediation KW - mindfulness KW - psychometric properties KW - content validation N2 - Background: Attention is at the base of more complex cognitive processes, and its deficits can significantly impact safety and health. Attention can be impaired by neurodevelopmental and acquired disorders. One validated theoretical model to explain attention processes and their deficits is the hierarchical model of Sohlberg and Mateer. This model guides intervention development to improve attention following an acquired disorder. Another way to stimulate attention functions is to engage in the daily practice of mindfulness, a multicomponent concept that can be explained by the theoretical model of Baer and colleagues. Mobile apps offer great potential for practicing mindfulness daily as they can easily be used during daily routines, thus facilitating transfer. Laverdière and colleagues have developed such a mobile app called Focusing, which is aimed at attention training using mindfulness-inspired attentional exercises. However, this app has not been scientifically validated. Objective: This research aims to analyze the logical content validity and ecological content validity of the Focusing app. Methods: Logical content validation was performed by 7 experts in neuropsychology and mindfulness. Using an online questionnaire, they determined whether the content of the attention training app exercises is representative of selected constructs, namely the theoretical model of attention by Sohlberg and Mateer and the theoretical model of mindfulness by Baer and colleagues. A focus group was subsequently held with the experts to discuss items that did not reach consensus in order to change or remove them. Ecological content validation was performed with 10 healthy adults. Participants had to explore all sections of the app and assess the usability, relevance, satisfaction, quality, attractiveness, and cognitive load associated with each section of the app, using online questionnaires. Results: Logical content validation results demonstrated a high content validity index (CVI) of the attention training app. Excellent scores (CVI ?0.78) in both the attention and mindfulness models were obtained for all exercises in the app, except 2 exercises. One of these exercises was subsequently modified to include expert feedback, and one was removed. Regarding ecological content validation, the results showed that workload, quality, user experience, satisfaction, and relevance of the app were adequate. The Mobile Application Rating Scale questionnaire showed an average quality rating between 3.75/5 (SD 0.41) (objective quality) and 3.65/5 (SD 0.36) (subjective quality), indicating acceptable quality. The mean global attractiveness rating from the AttrakDiff questionnaire was 2.36/3 (SD 0.57), which represents one of the strengths of the app.  Conclusions: Logical and ecological content validation showed that Focusing is theoretically valid, with a high level of agreement among experts and healthy participants. This tool can be tested to train attention processes after a neurological insult such as traumatic brain injury. UR - https://formative.jmir.org/2025/1/e64174 UR - http://dx.doi.org/10.2196/64174 UR - http://www.ncbi.nlm.nih.gov/pubmed/40202789 ID - info:doi/10.2196/64174 ER - TY - JOUR AU - Lalk, Christopher AU - Väth, Teresa AU - Hanraths, Sofie AU - Pruessner, Luise AU - Timm, Christina AU - Hartmann, Steffen AU - Barnow, Sven AU - Rubel, Julian PY - 2025/4/2 TI - Evaluation of an Online-Based Self-Help Program for Patients With Panic Disorder: Randomized Controlled Trial JO - J Med Internet Res SP - e54062 VL - 27 KW - internet-based CBT KW - agoraphobia KW - well-being KW - iCBT KW - internet-based intervention KW - panic disorder with and without agoraphobia KW - panic disorder KW - self-help KW - quality of life KW - effectiveness KW - online KW - self-help intervention KW - panic symptoms KW - daily functioning N2 - Background: Panic disorder is an anxiety disorder marked by severe fear of panic attacks in the absence of causes. Agoraphobia is a related anxiety disorder, which involves fear and avoidance of specific situations in which escape or help may be difficult. Both can be debilitating and impair well-being. One treatment option may be internet-based cognitive behavioral therapy (iCBT), which allows large-scale application and may overcome treatment barriers for some individuals. Objective: This study aimed to evaluated the effectiveness of a novel online self-help intervention for panic disorder with or without agoraphobia. As our primary hypotheses, we expected the intervention to improve panic and agoraphobia symptoms and well-being. Our secondary hypotheses entailed improvements in daily functioning, mental health literacy, working ability, and health care use in the intervention group. Methods: German-speaking patients (N=156) aged 18-65 years with internet access and a diagnosis of panic disorder with or without agoraphobia were recruited for this randomized controlled trial. The intervention group (n=82) received access to a 12-week online self-help program entailing psychoeducation, cognitive restructuring, exposure, and mindfulness elements. The control group (n=72) received care as usual during the study period and was offered the prospect of using the program after 12 weeks. The primary outcomes were assessed via the Panic and Agoraphobia Scale (PAS) and the WHO (World Health Organization)-5 Well-Being Index (WHO-5). Mixed effect models were computed using multivariate imputation by chained equation for the analysis of intervention effects. Results: In the intervention group, participants completed on average 7.3 out of 12 (60.8%) modules, and 27 out of 82 (32.1%) participants finished the whole course. Changes in PAS revealed a significant effect in favor of the intervention group (t110.1=?2.22, Padj=.03) with a small to moderate effect size (d=?0.37, 95% CI ?0.70 to ?0.04). No significant effect was found for the second primary outcome WHO-5 (t149.8=1.35, Padj=.09) or the secondary outcomes. Improvements were observed in anxiety (t206.8=?4.12; P<.001; Cohen d=?0.60, 95% CI ?0.089 to ?0.32) and depression (t257.4=?3.20; P<.001; Cohen d=?0.41 95% CI ?0.66 to ?0.16). No negative effects were associated with the intervention (t125=?1.14, P=.26). Conclusions: The presented online intervention can help reduce the core symptomatology of panic disorder and agoraphobia, as well as anxiety symptoms and associated depression. No effects were found for well-being and secondary outcomes. This may be due to higher illness burden in the intervention group and possibly the COVID pandemic, which caused unique challenges to patients suffering from panic disorder. Therefore, further research and intervention adaptations may be warranted to improve these outcomes. Trial Registration: German Clinical Trials Register DRKS00023800; https://drks.de/search/en/trial/DRKS00023800 UR - https://www.jmir.org/2025/1/e54062 UR - http://dx.doi.org/10.2196/54062 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54062 ER - TY - JOUR AU - Kim, Jaehyun AU - Oh, Hayoung AU - Yoon, Sungmin Anderson PY - 2025/3/27 TI - Mindfulness-Based Cognitive Therapy?Game: An Ironic Way to Treat Internet Gaming Disorder JO - J Med Internet Res SP - e65786 VL - 27 KW - cognitive behavior therapy KW - psychosocial intervention KW - video games KW - internet gaming disorder KW - internet addiction KW - mindfulness KW - mental health UR - https://www.jmir.org/2025/1/e65786 UR - http://dx.doi.org/10.2196/65786 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65786 ER - TY - JOUR AU - Saskovets, Marina AU - Saponkova, Irina AU - Liang, Zilu PY - 2025/3/24 TI - Effects of Sound Interventions on the Mental Stress Response in Adults: Scoping Review JO - JMIR Ment Health SP - e69120 VL - 12 KW - mental stress KW - anxiety KW - sound therapy KW - music therapy KW - psychoacoustics KW - expressive sounds KW - stress reduction KW - stress management KW - stress relief KW - stress markers KW - relaxation KW - personalized therapy KW - PRISMA N2 - Background: This scoping review examines the effects of various sound interventions, including music, natural sounds, and speech, on the stress response in adults. Objective: The review aims to identify key therapeutic factors, including sound type, individual listener characteristics, and environmental influences. It also synthesizes evidence on physiological responses to sound interventions and highlights current research gaps. Methods: We conducted a comprehensive search using databases such as PubMed, Web of Science, Scopus, and PsycINFO, focusing on studies from 1990 to 2024. Eligible studies included randomized controlled trials, clinical trials, and laboratory experiments that measured stress through physiological markers (eg, heart rate variability and cortisol) and self-reports. A total of 34 studies were included, and thematic analysis was conducted to identify recurring themes in the findings. Results: The findings suggest that music, especially classical and self-selected pieces, effectively reduces physiological stress markers, including cortisol levels, heart rate variability, and blood pressure. Nonmusical sounds, such as nature sounds and calming voices, also demonstrate potential for stress relief, although research in this area remains limited. While most sound interventions showed positive effects, some studies reported adverse effects, indicating that sound can both alleviate and induce stress. The outcomes were substantially affected by contextual factors such as personal preferences, delivery methods, cultural context, and emphasizing the importance of personalized interventions. Conclusions: Sound interventions offer promising, noninvasive methods for stress reduction. This review suggests that future research should address gaps in the study of nonmusical sound interventions and further investigate the neural mechanisms underlying stress responses to sound. International Registered Report Identifier (IRRID): RR2-10.2196/54030 UR - https://mental.jmir.org/2025/1/e69120 UR - http://dx.doi.org/10.2196/69120 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/69120 ER - TY - JOUR AU - Lai, Yi-Jen AU - Chiu, Hsiao-Yean AU - Wu, Ko-Chiu AU - Chang, Chun-Wei PY - 2025/3/4 TI - Diaphragmatic Breathing Interfaces to Promote Relaxation for Mitigating Insomnia: Pilot Study JO - JMIR Serious Games SP - e67000 VL - 13 KW - brief behavioral treatment for insomnia KW - sleep self-efficacy KW - mobile health KW - mHealth KW - breathing training cognitive load KW - attention KW - gamification KW - diaphragmatic breathing KW - insomnia KW - sleep KW - games KW - relaxation KW - breathing KW - breathing guidance KW - questionnaire KW - mental KW - cognition N2 - Background: Brief behavioral treatment for insomnia is an effective short-term therapy focusing on stimulus control and sleep restriction to enhance sleep quality. As a crucial part of this therapy, diaphragmatic breathing is often recommended when patients fail to fall asleep within 30 minutes. With the rise of health apps and gamification, these tools are increasingly seen as effective ways to boost self-efficacy and user engagement; however, traditional games tend to increase attention, which can negatively impact sleep and contradicts the aim of sleep therapy. This study thus explored the potential for gamification techniques to promote relaxation without disrupting sleep processes. Objective: The study developed 4 breathing guidance mechanisms, ranging from concrete to abstract: number countdown, zoom-in/out, up/down, and color gradients. The objective was to explore the relationship between game mechanics, cognitive load, relaxation effects, and attention as well as to understand how different designs impact users with varying levels of insomnia. Methods: The study was conducted in 2 phases. The first phase involved a questionnaire on the 4 guidance mechanisms. In the second phase, 33 participants classified by insomnia severity completed a Sleep Self-Efficacy Scale. They then engaged in 5 minutes of diaphragmatic breathing using each of the 4 interfaces. Relaxation effects were measured using heart rate variability via a smartwatch, attention and relaxation levels via an electroencephalogram device, and respiratory rate via a smartphone. Participants also completed the Game Experience Questionnaire and NASA Task Load Index, followed by user interviews. Results: The results indicated that competence, immersion, and challenge significantly influenced cognitive load. Specifically, competence and immersion reduced cognitive load, while challenge, negative affect, and positive affect were correlated with relaxation. Negative affect showed a positive correlation with the mean root mean square of successive differences, while positive affect exhibited a negative correlation with the mean root mean square of successive differences. Cognitive load was found to affect both relaxation and attention, with a negative correlation between mental demand and attention and a positive correlation between temporal demand and respiratory rate. Sleep self-efficacy was negatively correlated with temporal demand and negative affect and positively correlated with competence and immersion. Conclusions: Interfaces offering moderate variability and neither overly abstract nor too concrete guidance are preferable. The up/down interface was most effective, showing the best overall relaxation effect. Conversely, the number countdown interface was stress-inducing, while the zoom-in/out interface had a significant impact on insomnia-related issues, making them less suitable for insomnia-related breathing exercises. Participants showed considerable variability in their response to the color gradient interface. These findings underscore the importance of carefully considering game design elements in relaxation training. It is essential that breathing guidance designs account for the impact of the game experience to effectively promote relaxation in users. UR - https://games.jmir.org/2025/1/e67000 UR - http://dx.doi.org/10.2196/67000 UR - http://www.ncbi.nlm.nih.gov/pubmed/40053714 ID - info:doi/10.2196/67000 ER - TY - JOUR AU - Zhu, Tingfei AU - Zhang, Liuyi AU - Weng, Wenqi AU - Gan, Ruochen AU - Sun, Limin AU - Wei, Yanping AU - Zhu, Yueping AU - Yu, Hongyan AU - Xue, Jiang AU - Chen, Shulin PY - 2025/2/13 TI - Effectiveness of an Internet-Based, Self-Guided, Short-Term Mindfulness Training (ISSMT) Program for Relieving Depressive Symptoms in the Adult Population in China: Single-Blind, Randomized Controlled Trial JO - J Med Internet Res SP - e55583 VL - 27 KW - internet-based KW - self-guided KW - short-term KW - mindfulness KW - depression KW - randomized controlled trial N2 - Background: Depression is a significant global public health issue, and in China, access to mental health services remains limited despite high demand. Research has shown that mindfulness can effectively alleviate depressive symptoms and that telehealth solutions offer a promising avenue for addressing this service gap. Despite this potential, there are currently few studies in China focusing on short-term online mindfulness training. Most existing online mindfulness studies relied on traditional 8-week programs, which can be challenging for participant adherence due to limited accessibility and high dropout rates. Additionally, limited research exists on short-term online mindfulness interventions, and findings remain inconsistent. Objective: This study aimed to develop and evaluate an internet-based, self-guided, short-term mindfulness training (ISSMT) program based on the Monitor and Acceptance Theory (MAT) to reduce depression symptoms. Methods: The ISSMT program was delivered via an online platform, ?Hi Emotion,? and was accessible to the general public. Interested individuals aged 18 years and older were randomized into either the ISSMT group or a wait-list control group. Participants in the ISSMT group received daily reminders to participate in a 15- to 20-minute session over a 14-day training period. Measurements, including mindfulness and depressive symptoms, were collected at baseline and weekly for the subsequent 3 weeks. Results: A total of 205 adults participated in the 14-day online intervention. Linear mixed models were used to analyze both per-protocol (PP) and intention-to-treat (ITT) samples. Compared with the wait-list control group, participants in the ISSMT group showed significant improvements in mindfulness (Cohen d=0.44 for ITT; Cohen d=0.55 for PP) and reductions in depressive symptoms (Cohen d=0.50 for ITT; Cohen d=0.53 for PP). Furthermore, participants expressed high acceptance of this training format with a relatively low dropout rate (<40%). Conclusions: The ISSMT program based on the MAT effectively enhanced mindfulness and alleviated depressive symptoms. This intervention could be considered for integration into psychosocial service systems to improve mental health outcomes and help bridge the gap between limited resources and the high demand for services in China. Future research should focus on personalizing these programs and incorporating advanced technologies to enhance their effectiveness and user engagement. Trial Registration: Open Science Framework; https://doi.org/10.17605/OSF.IO/8P4V6 UR - https://www.jmir.org/2025/1/e55583 UR - http://dx.doi.org/10.2196/55583 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55583 ER - TY - JOUR AU - Verstegen, Amandine AU - Van Daele, Tom AU - Bonroy, Bert AU - Debard, Glen AU - Sels, Romy AU - van Loo, Marlon AU - Bernaerts, Sylvie PY - 2025/2/13 TI - Designing a Smartphone-Based Virtual Reality App for Relaxation: Qualitative Crossover Study JO - JMIR Form Res SP - e62663 VL - 9 KW - smartphone-based virtual reality KW - virtual reality KW - relaxation KW - stress KW - user experience KW - mobile phone N2 - Background: Accumulating evidence supports the use of virtual reality (VR) in mental health care, with one potential application being its use to assist individuals with relaxation exercises. Despite studies finding support for the potential of VR to effectively aid in relaxation, its implementation remains limited outside of specialized clinics. Known barriers are insufficient knowledge regarding VR operation, lack of availability of VR relaxation apps tailored to local health care systems, and cost concerns. Unfortunately, many VR relaxation apps are designed exclusively for stand-alone headsets, limiting accessibility for a broad audience. Objective: We aimed to design an accessible, smartphone-based VR relaxation app based on user preferences. This paper describes the assessment of 2 stand-alone VR relaxation apps and the resulting smartphone-based VR relaxation app design. Methods: Overall, 30 participants (n=23, 77% women; n=7, 23% men) took part in 2 separate VR sessions, assessing 1 of the 2 VR relaxation apps (Flowborne and Calm Place) in each session. After each session, participants were presented with open-ended questions to assess their experiences via a web-based survey tool. These questions explored positive and negative features, shortcomings, and suggestions for improvements while also allowing space for additional remarks concerning the 2 VR relaxation apps. Three of the authors analyzed the responses using inductive thematic analysis, a process comprising 6 phases. Results: Across both the apps, 5 recurring themes and 13 recurring subthemes were identified in the participants? answers: audio (music and sounds, guidance), visuals (content, realism, variation and dynamics in the environment), features (language, options, feedback and instructions, duration, exercise), implementation (technical aspects, cybersickness, acceptability and usability), and experience. We analyzed the participants? findings and conducted a literature review, which served as the basis for developing the app. The resulting app is a Dutch-language, smartphone-based VR relaxation app, with customization options including 3 types of relaxation exercises, 2 guiding voices, and 3 different environments. Efforts have been made to ensure maximum variation and dynamism in the environments. Calming music and nature sounds accompany the exercises. The efficacy and effectiveness of the resulting app design were not assessed. Conclusions: This study provides insights into key features of VR relaxation apps, which were subsequently used for the development of a novel smartphone-based VR relaxation app. Further research concerning the effectiveness of this app, along with a broader evaluation of the efficacy and user feedback for smartphone-based VR relaxation apps, is needed. More generally, there is a clear need for more research on the impact of interactivity, biofeedback, and type of environment in VR relaxation. UR - https://formative.jmir.org/2025/1/e62663 UR - http://dx.doi.org/10.2196/62663 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/62663 ER - TY - JOUR AU - Klein Haneveld, Lisa AU - Dekkers, Tessa AU - Bouman, A. Yvonne H. AU - Scholten, Hanneke AU - Weerdmeester, Joanneke AU - Kelders, M. Saskia AU - Kip, Hanneke PY - 2025/2/12 TI - The Effect of the Virtual Reality?Based Biofeedback Intervention DEEP on Stress, Emotional Tension, and Anger in Forensic Psychiatric Inpatients: Mixed Methods Single-Case Experimental Design JO - JMIR Form Res SP - e65206 VL - 9 KW - virtual reality KW - VR KW - diaphragmatic breathing KW - biofeedback KW - DEEP KW - forensic psychiatry KW - mental health KW - stress KW - single-case experimental design KW - experience sampling method N2 - Background: Decreasing aggression through stress reduction is an important part of forensic psychiatric treatment. DEEP is an experience-based virtual reality intervention that uses biofeedback to train diaphragmatic breathing and increase relaxation. Although DEEP has shown promising results in reducing stress and anxiety in students and adolescents in special education, it has not been examined in forensic psychiatric populations. Objective: This study aimed to evaluate DEEP?s potential to reduce stress, emotional tension, and anger in forensic psychiatric inpatients. Methods: A mixed methods, alternating treatment, single-case experimental design was conducted with 6 Dutch forensic inpatients. For 20 days, participants engaged in 4 DEEP sessions. Experience sampling was used for continuous monitoring of stress, emotional tension, and anger twice daily. A repeated linear mixed model was used as a primary statistical approach for analyzing the experience sampling data as well as visual analyses. Finally, semistructured interviews were conducted with participants and health care professionals to compare quantitative with qualitative results. Results: Of the 6 participants, 3 (50%) completed all 4 DEEP sessions, while the other 3 (50%) missed one session due to technical difficulties or absence from the inpatient clinic. P1 showed a significant reduction of stress after session 2 (?=?.865; P=.005). No significant changes over time were found, although an experienced effect was reported during the interviews. P2 showed no significant results. They reported the sessions as being repetitive, with no experienced effect. P3 showed a momentary increase of emotional tension after the first session (?=?.053; P=.002), but no changes were observed over time. No experienced effects were reported in the interview. P4 did not show significant results over time, and was hesitant to report clear experienced effects. P5 showed a significant decline of emotional tension (?=?.012; P=.006), stress (?=?.014; P=.007), and anger (?=?.007; P=.02) over time. They also reported short-term experienced effects in the interview. P6 showed a significant decline of stress over time (?=?.029; P<.001) and reported experiencing substantial effects. Finally, health care professionals reported a relaxing effect of DEEP in their patients but did not expect many long-term effects because no clear behavioral changes were observed. Conclusions: DEEP shows promise in teaching deep breathing techniques to forensic psychiatric inpatients, potentially decreasing stress, emotional tension, and anger in some patients. However, DEEP is not a one-size-fits-all intervention that supports every patient because the effectiveness on the outcome measures varied among participants. To increase effectiveness, emphasis should be put on supporting patients to transfer deep breathing skills into their daily lives. This highlights the importance for the structural integration of DEEP into current treatment protocols. UR - https://formative.jmir.org/2025/1/e65206 UR - http://dx.doi.org/10.2196/65206 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65206 ER - TY - JOUR AU - López-del-Hoyo, Yolanda AU - Fernández-Martínez, Selene AU - Perez-Aranda, Adrian AU - Monreal-Bartolomé, Alicia AU - Barceló-Soler, Alberto AU - Camarero-Grados, Loreto AU - Armas-Landaeta, Carilene AU - Guzmán-Parra, José AU - Carbonell, Vera AU - Campos, Daniel AU - Chen, Xinyuan AU - García-Campayo, Javier PY - 2025/2/3 TI - Effectiveness of a Web-Based Self-Guided Intervention (MINDxYOU) for Reducing Stress and Promoting Mental Health Among Health Professionals: Results From a Stepped-Wedge Cluster Randomized Trial JO - J Med Internet Res SP - e59653 VL - 27 KW - eHealth KW - health professionals KW - stress KW - mental health KW - stress reduction KW - web-based intervention KW - stepped-wedge design KW - randomized controlled trial N2 - Background: The high levels of sustained stress that health professionals often experience are a significant risk factor for developing mental health problems, such as anxiety, depression, and somatic symptoms, that not only affect their well-being but also have major social and organizational consequences. Different interventions, including those based on third-wave psychotherapy principles (ie, mindfulness, compassion, and acceptance), have proven to be effective in reducing stress in this population. Among them, those delivered on the web constitute a promising alternative with notable advantages in accessibility and flexibility, but some adherence inconveniences may limit their efficacy. Objective: This study aimed to evaluate the effectiveness of the MINDxYOU program, a web-based self-guided intervention based on third-wave psychotherapy principles, to reduce perceived stress and promote mental health in a sample of health professionals. Methods: In a stepped-wedge cluster randomized design, 357 health professionals from health centers in Aragon and Málaga, Spain, were recruited. They were divided into 6 clusters?3 per region?and randomly assigned to 1 of the 3 sequences, each starting with a control phase and then transitioning to the intervention phase (the MINDxYOU program) after 8, 16, or 24 weeks. This self-guided, web-based program, designed to be completed over 8 weeks, included weekly contact (via WhatsApp, call, or email) from the research team to promote adherence. Participants were assessed on the web every 8 weeks for 5 assessments. Perceived stress was the study?s primary outcome, with additional measures of clinical factors (anxiety, depression, and somatization) and process variables (resilience, mindfulness, compassion, and acceptance). Results: The program was initiated by 229 participants, 112 (48.9%) of whom were completers (ie, completed at least 3 of the 4 modules). Perceived stress demonstrated a significant reduction both when considering the entire sample (?=?1.08, SE 0.51; P=.03) and the sample of completers (?=?1.84, SE 0.62; P=.003). The proportion of participants reflecting ?low stress? increased after the treatment (n=90, 46.6% vs n=100, 28.8% at baseline). Intracluster analysis revealed that pre- versus postintervention moderate effects were present in 2 clusters (Cohen d=0.46 and 0.62), and these were maintained in subsequent assessments. The linear mixed-effects models also showed that depression, anxiety, and somatization, as well as resilience, self-compassion, and some mindfulness facets, experienced significant improvements (P<.05) when comparing the intervention and control phases. Conclusions: The MINDxYOU program was effective in reducing perceived stress and promoting mental health, as well as increasing resilience, mindfulness facets, and self-compassion. These effects suggest that participants experienced a tangible improvement that could potentially enhance their well-being. Adherence to the intervention was moderate, while program use was notable compared to similar interventions. Finding ways to promote adherence to the intervention would contribute to increasing the effectiveness of this program. Trial Registration: ClinicalTrials.gov NCT05436717; https://clinicaltrials.gov/study/NCT05436717 International Registered Report Identifier (IRRID): RR2-10.1186/s12912-022-01089-5 UR - https://www.jmir.org/2025/1/e59653 UR - http://dx.doi.org/10.2196/59653 UR - http://www.ncbi.nlm.nih.gov/pubmed/39899345 ID - info:doi/10.2196/59653 ER - TY - JOUR AU - Gu, Chenyu AU - Qian, Liquan AU - Zhuo, Xiaojie PY - 2025/1/28 TI - Mindfulness Intervention for Health Information Avoidance in Older Adults: Mixed Methods Study JO - JMIR Public Health Surveill SP - e69554 VL - 11 KW - health information avoidance KW - cyberchondria KW - self-determination theory KW - mindfulness KW - elderly N2 - Background: The global aging population and rapid development of digital technology have made health management among older adults an urgent public health issue. The complexity of online health information often leads to psychological challenges, such as cyberchondria, exacerbating health information avoidance behaviors. These behaviors hinder effective health management; yet, little research examines their mechanisms or intervention strategies. Objective: This study investigates the mechanisms influencing health information avoidance among older adults, emphasizing the mediating role of cyberchondria. In addition, it evaluates the effectiveness of mindfulness meditation as an intervention strategy to mitigate these behaviors. Methods: A mixed methods approach was used, combining quantitative and qualitative methodologies. Substudy 1 developed a theoretical model based on self-determination theory to explore internal (positive metacognition and health self-efficacy) and external (subjective norms and health information similarity) factors influencing health information avoidance, with cyberchondria as a mediator. A cross-sectional survey (N=236) was conducted to test the proposed model. Substudy 2 involved a 4-week mindfulness meditation intervention (N=94) to assess its impact on reducing health information avoidance behaviors. Results: Study 1 showed that positive metacognition (?=.26, P=.002), health self-efficacy (?=.25, P<.001), and health information similarity (?=.29, P<.001) significantly predicted health information avoidance among older adults. Cyberchondria mediated these effects: positive metacognition (effect=0.106, 95% CI 0.035-0.189), health self-efficacy (effect=0.103, 95% CI 0.043-0.185), and health information similarity (effect=0.120, 95% CI 0.063-0.191). Subjective norms did not significantly predict health information avoidance (?=?.11, P=.13), and cyberchondria did not mediate this relationship (effect=?0.045, 95% CI ?0.102 to 0.016). Study 2 found that after the 4-week mindfulness intervention, the intervention group (group 1: n=46) exhibited significantly higher mindfulness levels than the control group (group 2: n=48; Mgroup1=4.122, Mgroup2=3.606, P<.001) and higher levels compared with preintervention (Mt2=4.122, Mt1=3.502, P<.001, where t1=preintervention and t2=postintervention). However, cyberchondria levels did not change significantly (Mt1=2.848, Mt2=2.685, P=.18). Nevertheless, the results revealed a significant interaction effect between mindfulness and cyberchondria on health information avoidance (effect=?0.357, P=.002, 95% CI ?0.580 to ?0.131), suggesting that mindfulness intervention effectively inhibited the transformation of cyberchondria into health information avoidance behavior. Conclusions: This study reveals the role of cyberchondria in health information avoidance and validates mindfulness meditation as an effective intervention for mitigating such behaviors. Findings offer practical recommendations for improving digital health information delivery and health management strategies for older adults. UR - https://publichealth.jmir.org/2025/1/e69554 UR - http://dx.doi.org/10.2196/69554 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/69554 ER - TY - JOUR AU - Antico, Lia AU - Brewer, Judson PY - 2025/1/24 TI - Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach JO - JMIR Form Res SP - e63197 VL - 9 KW - burnout KW - anxiety KW - empathy fatigue KW - physician KW - mindfulness KW - digital therapeutics KW - app KW - smartphone KW - podcast KW - compassion KW - health care provider KW - training KW - physician burnout KW - cynicism KW - efficacy KW - treatment KW - meditation KW - chronic KW - workplace stress KW - digital health KW - mHealth KW - mobile phone N2 - Background: Physician burnout is widespread in health care systems, with harmful consequences on physicians, patients, and health care organizations. Mindfulness training (MT) has proven effective in reducing burnout; however, its time-consuming requirements often pose challenges for physicians who are already struggling with their busy schedules. Objective: This study aimed to design a short and pragmatic digital MT program with input from clinicians specifically to address burnout and to test its efficacy in physicians. Methods: Two separate nonrandomized pilot studies were conducted. In the first study, 27 physicians received the digital MT in a podcast format, while in the second study, 29 physicians and nurse practitioners accessed the same training through a free app-based platform. The main outcome measure was cynicism, one dimension of burnout. The secondary outcome measures were emotional exhaustion (the second dimension of burnout), anxiety, depression, intolerance of uncertainty, empathy (personal distress, perspective taking, and empathic concern subscales), self-compassion, and mindfulness (nonreactivity and nonjudgment subscales). In the second study, worry, sleep disturbances, and difficulties in emotion regulation were also measured. Changes in outcomes were assessed using self-report questionnaires administered before and after the treatment and 1 month later as follow-up. Results: Both studies showed that MT decreased cynicism (posttreatment: 33% reduction; P?.04; r?0.41 and follow-up: 33% reduction; P?.04; r?0.45), while improvements in emotional exhaustion were observed solely in the first study (25% reduction, P=.02, r=.50 at posttreatment; 25% reduction, P=.008, r=.62 at follow-up). There were also significant reductions in anxiety (P?.01, r?0.49 at posttreatment; P?.01, r?0.54 at follow-up), intolerance of uncertainty (P?.03, r?.57 at posttreatment; P<.001, r?0.66 at follow-up), and personal distress (P=.03, r=0.43 at posttreatment; P=.03, r=0.46 at follow-up), while increases in self-compassion (P?.02, r?0.50 at posttreatment; P?.006, r?0.59 at follow-up) and mindfulness (nonreactivity: P?.001, r?0.69 at posttreatment; P?.004, r?0.58 at follow-up; nonjudgment: P?.009, r?0.50 at posttreatment; P?.03, r?0.60 at follow-up). In addition, the second study reported significant decreases in worry (P=.04, r=0.40 at posttreatment; P=.006, r=0.58 at follow-up), sleep disturbances (P=.04, r=0.42 at posttreatment; P=.01, r=0.53 at follow-up), and difficulties in emotion regulation (P=.005, r=0.54 at posttreatment; P<.001, r=0.70 at follow-up). However, no changes were observed over time for depression or perspective taking and empathic concern. Finally, both studies revealed significant positive correlations between burnout and anxiety (cynicism: r?0.38; P?.04; emotional exhaustion: r?0.58; P?.001). Conclusions: To our knowledge, this research is the first where clinicians were involved in designing an intervention targeting burnout. These findings suggest that this digital MT serves as a viable and effective tool for alleviating burnout and anxiety among physicians. Trial Registration: ClinicalTrials.gov NCT06145425; https://clinicaltrials.gov/study/NCT06145425 UR - https://formative.jmir.org/2025/1/e63197 UR - http://dx.doi.org/10.2196/63197 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63197 ER - TY - JOUR AU - Rizzi, Silvia AU - Pavesi, Chiara Maria AU - Moser, Alessia AU - Paolazzi, Francesca AU - Marchesoni, Michele AU - Poggianella, Stefania AU - Gadotti, Erik AU - Forti, Stefano PY - 2025/1/17 TI - A Mindfulness-Based App Intervention for Pregnant Women: Qualitative Evaluation of a Prototype Using Multiple Case Studies JO - JMIR Form Res SP - e58265 VL - 9 KW - mindfulness KW - promoting well-being KW - pregnancy KW - eHealth KW - mHealth KW - mobile apps KW - development KW - usability KW - user-centered design KW - well-being KW - maternal health KW - digital health KW - intervention KW - design KW - preliminary testing KW - technology-based KW - interview KW - multidisciplinary approach KW - mother KW - women KW - WhatsApp KW - email KW - midwife N2 - Background: Pregnancy is a complex period characterized by significant transformations. How a woman adapts to these changes can affect her quality of life and psychological well-being. Recently developed digital solutions have assumed a crucial role in supporting the psychological well-being of pregnant women. However, these tools have mainly been developed for women who already present clinically relevant psychological symptoms or mental disorders. Objective: This study aimed to develop a mindfulness-based well-being intervention for all pregnant women that can be delivered electronically and guided by an online assistant with wide reach and dissemination. This paper aimed to describe a prototype technology-based mindfulness intervention?s design and development process for pregnant women, including the exploration phase, intervention content development, and iterative software development (including design, development, and formative evaluation of paper and low-fidelity prototypes). Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=15), domain experts including mindfulness experts (n=2), communication experts (n=2), and psychologists (n=3), and target users including pregnant women (n=2), mothers with young children (n=2), and midwives (n=4). User-centered and service design methods, such as interviews and usability testing, were included to ensure user involvement in each phase. Domain experts evaluated a paper prototype, while target users evaluated a low-fidelity prototype. Intervention content was developed by psychologists and mindfulness experts based on the Mindfulness-Based Childbirth and Parenting program and adjusted to an electronic format through multiple iterations with stakeholders. Results: An 8-session intervention in a prototype electronic format using text, audio, video, and images was designed. In general, the prototypes were evaluated positively by the users involved. The questionnaires showed that domain experts, for instance, positively evaluated chatbot-related aspects such as empathy and comprehensibility of the terms used and rated the mindfulness traces present as supportive and functional. The target users found the content interesting and clear. However, both parties regarded the listening as not fully active. In addition, the interviews made it possible to pick up useful suggestions in order to refine the intervention. Domain experts suggested incorporating auditory components alongside textual content or substituting text entirely with auditory or audiovisual formats. Debate surrounded the inclusion of background music in mindfulness exercises, with opinions divided on its potential to either distract or aid in engagement. The target users proposed to supplement the app with some face-to-face meetings at crucial moments of the course, such as the beginning and the end. Conclusions: This study illustrates how user-centered and service designs can be applied to identify and incorporate essential stakeholder aspects in the design and development process. Combined with evidence-based concepts, this process facilitated the development of a mindfulness intervention designed for the end users, in this case, pregnant women. UR - https://formative.jmir.org/2025/1/e58265 UR - http://dx.doi.org/10.2196/58265 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58265 ER - TY - JOUR AU - Park, Sehwan AU - Cho, Young Hee AU - Park, Young Jin AU - Chung, Kyungmi AU - Jhung, Kyungun PY - 2025/1/17 TI - Development and Evaluation of a Mindfulness-Based Mobile Intervention for Perinatal Mental Health: Randomized Controlled Trial JO - J Med Internet Res SP - e56601 VL - 27 KW - anxiety KW - perinatal mental health KW - depression KW - mobile health care KW - mindfulness KW - mobile phone N2 - Background: Perinatal mental health problems, such as anxiety, stress, and depression, warrant particularly close monitoring and intervention, but they are often unaddressed in both obstetric and psychiatric clinics, with limited accessibility and treatment resources. Mobile health interventions may provide an effective and more accessible solution for addressing perinatal mental health. Development and evaluation of a mobile mental health intervention specifically for pregnant women are warranted. Objective: This study aimed to evaluate the effectiveness of a 4-week, self-administered mobile mindfulness intervention in reducing anxiety, depression, and stress, and improving emotional well-being, maternal-fetal attachment, and mindfulness skills in a general population of pregnant women. Methods: Pregnant women were recruited and randomized to an intervention or a wait-list control group. The intervention group participated in a self-administered 4-week smartphone-based mindfulness program. Anxiety, depression, and stress were assessed as primary outcomes at baseline and postintervention. Secondary outcomes were mental health well-being, maternal-fetal attachment, and skills of mindfulness. The usability of the mobile intervention was also evaluated. Results: A total of 133 pregnant women were randomly assigned to the intervention (n=66) or the control group (n=67). The overall dropout rate was 30% (39/133). Anxiety scores of the intervention group significantly decreased from baseline to postintervention (P=.03, Wilcoxon Signed-Rank test), whereas no significant changes were observed in the control group. Depression and stress scores showed no significant changes. Emotional well-being significantly improved in the intervention group (P=.01). Improvements were observed in maternal-fetal attachment, particularly in attributing characteristics to the fetus (P=.003) and in differentiating the self from the fetus (P=.006). Mindfulness awareness also showed significant improvement (P=.008). Significant between-group effects were identified for mindfulness awareness (P=.006) and attributing characteristics to the fetus (P=.002). After applying the false discovery rate corrections, within-group improvements in emotional well-being, maternal-fetal attachment, and mindfulness awareness remained significant, while between-group differences for emotional well-being and differentiation were not significant. Conclusions: A mobile mindfulness program effectively reduced anxiety and improved emotional well-being, maternal-fetal attachment, and mindfulness awareness in the general population of pregnant women. Mobile interventions may offer a cost-effective and feasible method for promoting perinatal mental health. Trial Registration: Clinical Research Information Service KCT0007166; https://tinyurl.com/458vfc4r UR - https://www.jmir.org/2025/1/e56601 UR - http://dx.doi.org/10.2196/56601 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56601 ER - TY - JOUR AU - Komariah, Maria AU - Maulana, Sidik AU - Amirah, Shakira AU - Platini, Hesti AU - Rahayuwati, Laili AU - Yusuf, Ah AU - Firdaus, Hasymi Mohd Khairul Zul PY - 2025/1/16 TI - Benefits of Remote-Based Mindfulness on Physical Symptom Outcomes in Cancer Survivors: Systematic Review and Meta-Analysis JO - JMIR Cancer SP - e54154 VL - 11 KW - cancer KW - physical symptoms KW - mindfulness KW - remote-based intervention KW - quality of life N2 - Background: Many cancer survivors experience a wide range of symptoms closely linked to psychological problems, highlighting the need for psychological treatment, one of the most popular being mindfulness. The use of the internet has greatly increased in the last decade, and has encouraged the use of remote-based interventions to help people living with cancer access treatment remotely via devices. Objective: The primary aim of this study was to explore the efficacy of internet-based mindfulness interventions on the physical symptoms of people living with cancer, where physical symptoms are defined as distressing somatic experiences (eg fatigue, insomnia, and pain) regardless of the underlying cause. The secondary aim was to investigate interventions for the quality of life (QoL). Methods: This study followed the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. Relevant articles were systematically searched using electronic databases, namely Scopus, Medline through PubMed, Cumulated Index in Nursing and Allied Health Literature (CINAHL) through EBSCOhost, and Cochrane Central Database. Randomized controlled and pilot trials involving adults and/or older adults with cancer and using remote-based mindfulness interventions compared to usual care were included. The quality of the trials included in this study was assessed using the revised Cochrane risk of bias, version 2.0. This study estimated the standardized mean difference (SMD) and mean difference (MD) with 95% CI. The I2 test was used to identify potential causes of heterogeneity. Publication bias was assessed using contour-enhanced funnel plots and the Egger linear regression test to reveal a small study effect. Results: The initial search yielded 1985 records, of which 13 studies were ultimately included. After treatment, remote-based mindfulness significantly reduced fatigue (SMD ?0.94; 95% CI: ?1.56 to ?0.33; P=.002), sleep disturbance (SMD ?0.36; 95% CI: ?0.60 to ?0.12; P=.004), and improved physical function (SMD .25; 95% CI: 0.09 to 0.41; P=.002) compared to that observed before treatment. However, compared with usual care, remote-based mindfulness showed a statistically significant reduction only in sleep disturbance (SMD: ?0.37; 95% CI: ?0.58 to ?0.16; P=.0006) after treatment. Moreover, remote-based mindfulness was not statistically significant in reducing pain both within and between groups. Conclusions: Remote-based mindfulness shows promise in reducing sleep disturbances; however, its impact on fatigue, pain, and physical function may be limited. UR - https://cancer.jmir.org/2025/1/e54154 UR - http://dx.doi.org/10.2196/54154 ID - info:doi/10.2196/54154 ER - TY - JOUR AU - Holley, Dan AU - Brooks, Amanda AU - Hartz, Matthew AU - Rao, Sudhir AU - Zaubler, Thomas PY - 2025/1/10 TI - mHealth-Augmented Care for Reducing Depression Symptom Severity Among Patients With Chronic Pain: Exploratory, Retrospective Cohort Study JO - JMIR Mhealth Uhealth SP - e52764 VL - 13 KW - mHealth KW - mobile health KW - app KW - behavioral health care KW - depression KW - mental health KW - screening KW - pain KW - chronic pain KW - psychiatric screenings KW - digital health care KW - psychiatry KW - psychiatric KW - longitudinal KW - assessment KW - behavioral KW - self-help KW - integrated KW - comorbidity KW - augmented care N2 - Background: Depression and chronic pain are commonly comorbid, mutually reinforcing, and debilitating. Emerging approaches to mobile behavioral health care (mHealth) promise to improve outcomes for patients with comorbid depression and chronic pain by integrating with existing care models to bolster support and continuity between clinical visits; however, the evidence base supporting the use of mHealth to augment care for this patient population is limited. Objective: To develop an evidence base that sets the stage for future research, we aimed to explore the associations between changes in depression severity and various integrated care models, with and without mHealth augmentation, among patients with comorbid depression and nonmalignant chronic pain. Methods: Our team leveraged retrospective, real-world data from 3837 patients with comorbid depression and nonmalignant chronic pain who received integrated behavioral health care (IBH) at a subspecialty pain clinic. We analyzed one IBH-only, non-mHealth cohort (n=2765), an mHealth-augmented cohort (n=844), and a collaborative care (CoCM)+mHealth cohort (n=136), which were supported by the NeuroFlow mHealth platform, and a pre-CoCM mHealth cohort (n=92), which was supported by the mHealth platform for 3 months prior to beginning the chronic pain treatment. We evaluated changes in depression severity between treatment cohorts via longitudinal analyses of both clinician- and mHealth-administered Patient Health Questionnaire-9 (PHQ-9) assessments. Results: mHealth-augmented integrated care led to significantly greater proportions of patients reaching clinical benchmarks for reduction (725/844, 86% vs 2112/2765, 76%), response (689/844, 82% vs 2027/2765, 73%), and remission (629/844, 75% vs 1919/2765, 69%) compared with integrated care alone. Furthermore, hierarchical regression modeling revealed that patients who received mHealth-augmented psychiatric CoCM experienced the greatest sustained reductions in on-average depression severity compared with other cohorts, irrespective of clinical benchmarks. In addition, patients who engaged with an mHealth platform before entering CoCM experienced a 7.2% reduction in average depression severity before starting CoCM treatment. Conclusions: Our findings suggest that mHealth platforms have the potential to improve treatment outcomes for patients with comorbid chronic pain and depression by providing remote measurement?based care, tailored interventions, and improved continuity between appointments. Moreover, our study set the stage for further research, including randomized controlled trials to evaluate causal relationships between mHealth engagement and treatment outcomes in integrated care settings. UR - https://mhealth.jmir.org/2025/1/e52764 UR - http://dx.doi.org/10.2196/52764 ID - info:doi/10.2196/52764 ER - TY - JOUR AU - Zhang, Lin AU - Huang, Shuang AU - Liu, Sha AU - Huang, Yuanxiu AU - Chen, Shan AU - Hu, Jinsong AU - Xu, Mingzhong PY - 2024/12/18 TI - Effectiveness of an Internet-Based Acceptance and Commitment Therapy Intervention for Reducing Psychological Distress in Health Care Professionals: Randomized Controlled Trial JO - J Med Internet Res SP - e59093 VL - 26 KW - acceptance and commitment therapy KW - internet-based intervention KW - stress KW - anxiety KW - depression KW - burnout KW - health care professionals KW - randomized controlled trial N2 - Background: Psychological distress is prevalent among health care professionals and can lead to poor-quality patient care. Internet-based acceptance and commitment therapy (iACT) is a promising intervention for improving mental health due to its low cost and easy access. However, there is limited evidence of its effectiveness in reducing health care professionals? psychological distress. Objective: This study aims to examine the effects of iACT on psychological distress (stress, anxiety, and depression) among health care professionals in China. Methods: From October 2022 to February 2023, a total of 108 health care professionals were recruited via WeChat and randomized into a 6-week iACT intervention program with therapist support (n=54) or waitlist control group (n=54). The intervention included 21 self-guided sessions combining teaching videos, mindfulness practices, and journal writing, followed by 7 live conferences to share experiences and discuss questions, all conducted via WeChat. Primary outcomes (stress, anxiety, and depression) and secondary outcomes (burnout and psychological flexibility) were collected using the Sojump platform, the most popular web-based survey platform in China. Generalized estimating equations were used to compare the outcomes between groups and assess the effects of group, time, and group-by-time interaction. Subgroup and sensitive analyses were performed to test the robustness of our findings across various groups. Results: Among the 108 health care professionals, 68 (63%) completed the follow-up assessment at week 10, including 35 (64.8%) in the iACT group and 33 (61.1%) in the waitlist control group. Of the 54 participants in the iACT group, all attended at least 2 sessions, and 25 attended all 28 sessions. On average, participants attended 20 (71%) sessions. The iACT group showed significant improvement in the Depression Anxiety and Stress Scales-21 total score (d=0.82, 95% CI 0.39-1.26), and the effects were sustained for 4 weeks after the intervention (d=1.08, 95% CI 0.57-1.59). Compared to the control group, the iACT group showed significantly lower scores in burnout at week 6 (d=1.42, 95% CI 0.95-1.89) and week 10 (d=1.52, 95% CI 0.98-2.06). The iACT group showed significantly higher psychological flexibility at week 6 (d=1.23, 95% CI 0.77-1.69) and week 10 (d=1.15, 95% CI 0.64-1.66). Conclusions: The iACT effectively decreased health care professionals? psychological distress and burnout and improved their psychological flexibility. Our findings provide implications and guidance for the development and broad implementation of iACT in health care settings to improve the mental health of health care professionals. Trial Registration: Chinese Clinical Trial Register ChiCTR2400093584; https://tinyurl.com/38werwsk UR - https://www.jmir.org/2024/1/e59093 UR - http://dx.doi.org/10.2196/59093 UR - http://www.ncbi.nlm.nih.gov/pubmed/39693127 ID - info:doi/10.2196/59093 ER - TY - JOUR AU - Anto, Ailin AU - Basu, Arunima AU - Selim, Rania AU - Foscht, Thomas AU - Eisingerich, Benedikt Andreas PY - 2024/12/17 TI - Open-World Games? Affordance of Cognitive Escapism, Relaxation, and Mental Well-Being Among Postgraduate Students: Mixed Methods Study JO - J Med Internet Res SP - e63760 VL - 26 KW - open-world games KW - cognitive escapism KW - relaxation KW - mental well-being KW - students KW - video games KW - stress KW - freedom to explore N2 - Background: Open-world games, characterized by their expansive and interactive environments, may offer unique cognitive escapism opportunities, potentially leading to relaxation and enhanced well-being. These games, such as ?The Legend of Zelda: Breath of the Wild? and ?The Legend of Zelda: Tears of the Kingdom,? allow players to experience a sense of freedom and autonomy, which can reduce stress and improve mental health. While previous research has examined the general impact of video games on mental well-being, specific studies on the effects of open-world games among postgraduate students are limited. Objective: This study aims to investigate the relationships between cognitive escapism provided by open-world games and their effects on relaxation and well-being. The goal was to understand how the immersive nature of these games contributes to stress reduction and overall mental health improvement among postgraduate students. Methods: A mixed methods approach was used, which involved in-depth exploratory qualitative interviews and a survey of 609 players of popular open-world games. Quantitative data were collected using standardized questionnaires to measure open-world games? affordance of cognitive escapism, relaxation, and well-being. Qualitative data were obtained through 32 in-depth interviews that explored players? experiences and perceptions of cognitive escapism, relaxation, and mental well-being. Results: Qualitative data (n=32; n=15, 47% female; n=16, 50% male; n=1, 3% preferred not to disclose gender; mean age 23.19, SD 2.19 y) revealed that cognitive escapism through immersive game worlds allowed players to temporarily disconnect from real-world stressors, resulting in enhanced mood and psychological well-being. Players indicated that the nonlinear gameplay and freedom to explore interactive environments provided a sense of relaxation and mental rejuvenation. Quantitative analysis (N=609) showed a substantial mediating role of relaxation in the relationship between cognitive escapism offered by open-world games and well-being. Specifically, cognitive escapism had a significant positive effect on players? relaxation (?=.15; SE 0.04; P<.001; 95% CI 0.0695-0.2331), which in turn had a significant and positive effect on players? well-being scores (?=.12; SE 0.04; P=.002; 95% CI 0.0445-0.2032). Conclusions: The study demonstrates that open-world games offer substantial benefits for cognitive escapism, significantly improving relaxation and well-being among postgraduate students. The immersive and autonomous nature of these games is crucial in reducing stress and enhancing mental health. Future research may investigate the long-term effects of regular engagement with open-world games and explore their potential therapeutic applications for managing stress and anxiety. UR - https://www.jmir.org/2024/1/e63760 UR - http://dx.doi.org/10.2196/63760 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63760 ER - TY - JOUR AU - Xian, Xuechang AU - Zhang, Xiaoran AU - Zheng, Danhe AU - Wang, Yanlin PY - 2024/12/16 TI - Mental Health Benefits of Listening to Music During COVID-19 Quarantine: Cross-Sectional Study JO - JMIR Form Res SP - e46497 VL - 8 KW - COVID-19 KW - quarantine KW - social connectedness KW - sense of security KW - mental well-being KW - cross-sectional study KW - contagion KW - treatment KW - music KW - security KW - mental health KW - questionnaire KW - China KW - intervention KW - relaxation KW - meditation KW - mental illness KW - stimuli KW - environmental N2 - Background: COVID-19 has posed a significant global threat to public health due to its high contagion risk and lack of effective treatment. While quarantine measures have been crucial in controlling the virus? spread, they have also contributed to negative impacts on individuals? mental health. Music listening has emerged as a potential coping mechanism, yet it remains unclear whether mental well-being varies across music preferences. Objective: This study examined individuals? music-listening preferences in the context of COVID-19 quarantine and assessed the mediation pathways linking 5 types of music to mental health levels, mediated by perceived social connectedness as well as sense of security. Methods: A web-based survey was conducted among people with quarantine experience in September 2022, in mainland China. A total of 712 valid questionnaires were returned and 596 samples were finally included in our study for mediation analysis. Results: The results revealed that the vast majority (596/623, 96%) of respondents had music-listening experiences during the COVID-19 quarantine, with pop music emerging as the most popular preference among respondents, while quyi was the least listened-to genre. Additionally, listening to music across 5 different genres appeared as a significant parameter indirectly linked to mental health through perceived social connectedness. Specifically, engaging with quyi was associated with higher levels of perceived social connectedness and sense of security, which in turn correlated with improved mental well-being. Conversely, individuals listening to jazz reported lower social connectedness and sense of security, which was subsequently linked to increased mental health problems. The potential reasons for these findings and implications are discussed. Conclusions: This study significantly contributes to the understanding of the mechanisms behind music-listening preferences in stressful environments. Specifically, our findings highlight the mediating roles of perceived social connectedness and sense of security in the relationship between music preferences and mental health outcomes during the quarantine period. These insights provide valuable guidance for developing interventions that use music to enhance mental health, thereby broadening the scope of studies on environmental stimuli and their impact on mental well-being. UR - https://formative.jmir.org/2024/1/e46497 UR - http://dx.doi.org/10.2196/46497 ID - info:doi/10.2196/46497 ER - TY - JOUR AU - Thimmapuram, Jayaram AU - Patel, D. Kamlesh AU - Bhatt, Deepti AU - Chauhan, Ajay AU - Madhusudhan, Divya AU - Bhatt, K. Kashyap AU - Deshpande, Snehal AU - Budhbhatti, Urvi AU - Joshi, Chaitanya PY - 2024/12/16 TI - Effect of a Web-Based Heartfulness Program on the Mental Well-Being, Biomarkers, and Gene Expression Profile of Health Care Students: Randomized Controlled Trial JO - JMIR Bioinform Biotech SP - e65506 VL - 5 KW - heartfulness KW - meditation KW - stress KW - anxiety KW - depression KW - interleukins KW - gene expression KW - dehydroepiandrosterone KW - DHEA KW - gene KW - mental health KW - randomized study KW - web-based program KW - mental well-being KW - well-being KW - mental KW - health care students KW - student KW - mRNA KW - messenger ribonucleic acid KW - youth KW - young adults KW - web-based KW - biomarker KW - RNA KW - bioinformatics KW - randomized KW - statistical analysis KW - nursing KW - physiotherapy KW - pharmacy N2 - Background: Health care students often experience high levels of stress, anxiety, and mental health issues, making it crucial to address these challenges. Variations in stress levels may be associated with changes in dehydroepiandrosterone sulfate (DHEA-S) and interleukin-6 (IL-6) levels and gene expression. Meditative practices have demonstrated effectiveness in reducing stress and improving mental well-being. Objective: This study aims to assess the effects of Heartfulness meditation on mental well-being, DHEA-S, IL-6, and gene expression profile. Methods: The 78 enrolled participants were randomly assigned to the Heartfulness meditation (n=42, 54%) and control (n=36, 46%) groups. The participants completed the Perceived Stress Scale (PSS) and Depression Anxiety Stress Scale (DASS-21) at baseline and after week 12. Gene expression with messenger RNA sequencing and DHEA-S and IL-6 levels were also measured at baseline and the completion of the 12 weeks. Statistical analysis included descriptive statistics, paired t test, and 1-way ANOVA with Bonferroni correction. Results: The Heartfulness group exhibited a significant 17.35% reduction in PSS score (from mean 19.71, SD 5.09 to mean 16.29, SD 4.83; P<.001) compared to a nonsignificant 6% reduction in the control group (P=.31). DASS-21 scores decreased significantly by 27.14% in the Heartfulness group (from mean 21.15, SD 9.56 to mean 15.41, SD 7.87; P<.001) while it increased nonsignificantly by 17% in the control group (P=.04). For the DASS-21 subcomponents?the Heartfulness group showed a statistically significant 28.53% reduction in anxiety (P=.006) and 27.38% reduction in stress (P=.002) versus an insignificant 22% increase in anxiety (P=.02) and 6% increase in stress (P=.47) in the control group. Further, DHEA-S levels showed a significant 20.27% increase in the Heartfulness group (from mean 251.71, SD 80.98 to mean 302.74, SD 123.56; P=.002) compared to an insignificant 9% increase in the control group (from mean 285.33, SD 112.14 to mean 309.90, SD 136.90; P=.10). IL-6 levels showed a statistically significant difference in both the groups (from mean 4.93, SD 1.35 to mean 3.67, SD 1.0; 28.6%; P<.001 [Heartfulness group] and from mean 4.52, SD 1.40 to mean 2.72, SD 1.74; 40%; P<.001 [control group]). Notably, group comparison at 12 weeks revealed a significant difference in perceived stress, DASS-21 and its subcomponents, and IL-6 (all P<.05/4). The gene expression profile with messenger RNA sequencing identified 875 upregulated genes and 1539 downregulated genes in the Heartfulness group compared to baseline, and there were 292 upregulated genes and 1180 downregulated genes in the Heartfulness group compared to the control group after the intervention. Conclusions: Heartfulness practice was associated with decreased depression, anxiety, and stress scores and improved health measures in DHEA-S and IL-6 levels. The gene expression data point toward possible mechanisms of alleviation of symptoms of stress, anxiety and depression. Trial Registration: ISRCTN Registry ISRCTN82860715; https://doi.org/10.1186/ISRCTN82860715 UR - https://bioinform.jmir.org/2024/1/e65506 UR - http://dx.doi.org/10.2196/65506 UR - http://www.ncbi.nlm.nih.gov/pubmed/39680432 ID - info:doi/10.2196/65506 ER - TY - JOUR AU - Tanaka-Kanegae, Ryohei AU - Yamada, Koji AU - Cook, M. Chad AU - Blonquist, M. Traci AU - Taggart, D. Kristen AU - Hamada, Koichiro PY - 2024/12/10 TI - Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e63078 VL - 12 KW - mindfulness KW - guided tea meditation KW - meditation KW - matcha KW - green tea KW - mobile app KW - smartphone KW - stress KW - mood KW - mHealth KW - mobile health KW - well-being KW - wellness N2 - Background: Mindfulness practices, such as breathing meditation (BM), reduce stress and enhance mood. One such practice is mindful eating, where a practitioner focuses on the five senses while eating or drinking. A novel set of prototypes has been developed, incorporating principles of mindful eating. These prototypes include matcha green tea and a mobile app that provides audio guidance for meditation during the preparation and consumption of the beverage (hereafter referred to as guided tea meditation [GTM]). Objective: This study assessed the feasibility and efficacy of GTM, evaluating meditation time, frequency, and prototype acceptability over 8 weeks, alongside changes in stress and mood. Additionally, other benefits of GTM were explored. Methods: A comparator group was established in which participants performed traditional BM without an app or audio guide (active control). This unblinded randomized controlled trial involved 100 healthy American volunteers (n=49 GTM, n=51 BM). During the 8-week study period, participants were encouraged to perform either GTM or BM for 10 minutes daily. The meditation activity was self-reported the following day. Only the GTM group assessed the prototype acceptability. The Perceived Stress Scale-10 was used to measure stress levels, while the Two-Dimensional Mood Scale was used to evaluate mood changes. Other meditation benefits were explored using a questionnaire. All questionnaires were presented and completed via an app. An intention-to-treat analysis was performed. Results: No significant between-group differences were found in total meditation time (P=.15) or frequency (P=.36). However, the weekly time and frequency of the GTM group remained above 50 minutes per week and 4 days per week, respectively. Over half of the GTM participants (?28/49, ?57%) accepted the prototype. The GTM group exhibited significant stress reductions at weeks 4 and 8 (both P<.001), similar to the BM group. Improvements in mood metrics were observed after a single GTM session on days 1 and 56, similar to the BM group. Moreover, increases in premeditation scores for relaxed and calm from day 1 to day 56 were significantly higher for the GTM group (P=.04 and .048, respectively). The majority of participants (?25/49, ?51%) assigned to GTM experienced positive changes in happiness, time management, quality of life, relationships, sleep, and work performance as they continued meditating. However, no significant between-group differences were found in these exploratory outcomes (P>.08). Conclusions: We believe that GTM exhibits good feasibility. Meanwhile, GTM reduced stress, improved mood, and let the practitioners feel other benefits, similar to BM. Long-term practitioners of GTM may even feel more relaxed and calmer in the state of premeditation than those who practice BM. Trial Registration: ClinicalTrials.gov NCT05832645; https://clinicaltrials.gov/study/NCT05832645 UR - https://mhealth.jmir.org/2024/1/e63078 UR - http://dx.doi.org/10.2196/63078 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63078 ER - TY - JOUR AU - Ng, Hydra Hei-Yin AU - Wu, W. Changwei AU - Hsu, Hao-Che AU - Huang, Chih-Mao AU - Hsu, Ai-Ling AU - Chao, Yi-Ping AU - Jung, Tzyy-Ping AU - Chuang, Chun-Hsiang PY - 2024/12/6 TI - Neurological Evidence of Diverse Self-Help Breathing Training With Virtual Reality and Biofeedback Assistance: Extensive Exploration Study of Electroencephalography Markers JO - JMIR Form Res SP - e55478 VL - 8 KW - biofeedback KW - virtual reality KW - breathing training KW - EEG KW - electroencephalography KW - effective connectivity N2 - Background: Recent advancements in virtual reality (VR) and biofeedback (BF) technologies have opened new avenues for breathing training. Breathing training has been suggested as an effective means for mental disorders, but it is difficult to master the technique at the beginning. VR-BF technologies address the problem of breathing, and visualizing breathing may facilitate the learning of breathing training. This study explores the integration of VR and BF to enhance user engagement in self-help breathing training, which is a multifaceted approach encompassing mindful breathing, guided breathing, and breath counting techniques. Objective: We identified 3 common breathing training techniques in previous studies, namely mindful breathing, guided breathing, and breath counting. Despite the availability of diverse breathing training methods, their varying effectiveness and underlying neurological mechanisms remain insufficiently understood. We investigated using electroencephalography (EEG) indices across multiple breathing training modalities to address this gap. Methods: Our automated VR-based breathing training environment incorporated real-time EEG, heart rate, and breath signal BF. We examined 4 distinct breathing training conditions (resting, mindful breathing, guided breathing, and breath counting) in a cross-sectional experiment involving 51 healthy young adults, who were recruited through online forum advertisements and billboard posters. In an experimental session, participants practiced resting state and each breathing training technique for 6 minutes. We then compared the neurological differences across the 4 conditions in terms of EEG band power and EEG effective connectivity outflow and inflow with repeated measures ANOVA and paired t tests. Results: The analyses included the data of 51 participants. Notably, EEG band power across the theta, alpha, low-beta, high-beta, and gamma bands varied significantly over the entire scalp (t ?1.96, P values <.05). Outflow analysis identified condition-specific variations in the delta, alpha, and gamma bands (P values <.05), while inflow analysis revealed significant differences across all frequency bands (P values <.05). Connectivity flow analysis highlighted the predominant influence of the right frontal, central, and parietal brain regions in the neurological mechanisms underlying the breathing training techniques. Conclusions: This study provides neurological evidence supporting the effectiveness of self-help breathing training through the combined use of VR and BF technologies. Our findings suggest the involvement of internal-external attention focus and the dorsal attention network in different breathing training conditions. There is a huge potential for the use of breathing training with VR-BF techniques in terms of clinical settings, the new living style since COVID-19, and the commercial value of introducing VR-BF breathing training into consumer-level digital products. Furthermore, we propose avenues for future research with an emphasis on the exploration of applications and the gamification potential in combined VR and BF breathing training. Trial Registration: ClinicalTrials.gov NCT06656741; https://clinicaltrials.gov/study/NCT06656741 UR - https://formative.jmir.org/2024/1/e55478 UR - http://dx.doi.org/10.2196/55478 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55478 ER - TY - JOUR AU - Blackmore, Rebecca AU - Giles, Claudia AU - Tremain, Hailey AU - Kelly, Ryan AU - Foley, Fiona AU - Fletcher, Kathryn AU - Nedeljkovic, Maja AU - Wadley, Greg AU - Seabrook, Elizabeth AU - Thomas, Neil PY - 2024/12/6 TI - Examining the Use of Virtual Reality to Support Mindfulness Skills Practice in Mood and Anxiety Disorders: Mixed Methods Study JO - J Med Internet Res SP - e45640 VL - 26 KW - virtual reality KW - mindfulness KW - mood disorders KW - anxiety disorders KW - depression KW - bipolar disorder N2 - Background: Virtual reality (VR) has been proposed as a technology to support mindfulness practice through promoting increased engagement and presence. The proposed benefits of this technology have been largely unexamined with clinical populations. Further research is required to understand its clinical potential and utility in improving and managing mental health symptoms. Objective: This study aims to investigate the proximal impacts of a single, brief, VR-supported mindfulness practice for individuals with a mood or anxiety disorder and to understand user experiences, which may affect the acceptability and efficacy of VR mindfulness for this population. Methods: This mixed methods study recruited 28 participants with a primary diagnosis of major depressive disorder, bipolar disorder, or anxiety disorder. Participants completed a mindfulness practice wearing a VR headset that was presenting an omnidirectional video of a forest scene, which was overlaid with a guided audio voiceover. Before and after the practice, measures were completed assessing state mindfulness (Toronto Mindfulness Scale), affect (Positive and Negative Affect Schedule), and anxiety (State-Trait Anxiety Inventory Y-1; n=27). Semistructured interviews were then held inquiring about the user experience and were analyzed using thematic analysis (n=24). Results: After completing the VR-supported mindfulness practice, both measures of state mindfulness on the Toronto Mindfulness Scale, mean curiosity and decentering, increased significantly (Cohen d=1.3 and 1.51, respectively; P<.001). Negative affect on the Positive and Negative Affect Schedule (Cohen d=0.62; P=.003) and State-Trait Anxiety Inventory Y-1 state anxiety (Cohen d=0.84; P<.001) significantly reduced. There was no significant change in positive affect (Cohen d=0.29; P=.08). Qualitative analysis of interviews identified 14 themes across 5 primary theme categories. The results suggested that being mindful during the use of the app was experienced as relatively effortless because of the visual and immersive elements. It was also experienced as convenient and safe, including when compared with prior traditional experiences of mindfulness. Participants also identified the uses for VR-supported mindfulness in managing emotions and symptoms of mental illness. Conclusions: The results provide preliminary evidence that VR-supported mindfulness can improve emotional states and manage mental health symptoms for those with mood or anxiety disorders. It offers some potential clinical applications for those with mood or anxiety disorders for exploration within future research. UR - https://www.jmir.org/2024/1/e45640 UR - http://dx.doi.org/10.2196/45640 UR - http://www.ncbi.nlm.nih.gov/pubmed/39641990 ID - info:doi/10.2196/45640 ER - TY - JOUR AU - Peng, L. Mary AU - Monin, Joan AU - Ovchinnikova, Polina AU - Levi, Amanda AU - McCall, Terika PY - 2024/12/3 TI - Psychedelic Art and Implications for Mental Health: Randomized Pilot Study JO - JMIR Form Res SP - e66430 VL - 8 KW - digital art KW - mental health KW - psychedelic art KW - well-being KW - pilot trial KW - digital health tool KW - art therapy N2 - Background: Psychedelic art (PA) emerged in the 1960s during the psychedelic era; then characterized by visuals induced by the ingestion of psychedelic drugs, it is now an art form known for its vibrant colors, distorted forms, and intricate patterns. Building upon the existing research on art viewing as an effective means to improving physiological and psychological well-being, viewing PA is postulated to evoke positive emotions and provide a meditative experience, contributing to improved mental well-being. Objective: This study aims to investigate how digitally rendered PA influences viewers? perceived emotional, mental, and physical states compared to imagery of natural scenery, offering insights into potential applications in mental health care and well-being. Methods: Overall, 102 participants age 18 to 35 years were randomly assigned to either the experimental group viewing 300 seconds of PA imagery (50/102, 49%) or the control group viewing 300 seconds of scenic imagery (52/102, 51%), after which every participant completed a survey that gathered qualitative data on the perceived impact of viewing their given imagery on their physical, mental, and emotional states through open-ended questions. Thematic analysis was conducted to identify the patterns of experiences reported by the participants. Results: Qualitative analysis unveiled a greater intensity and diversity of emotional, mental, and physical impacts induced by PA compared to natural scenery, including the sense of relaxation and peace, anxiety and stress alleviation, joy, thrill and sense of euphoria, sensations of awe and wonder, hypnotizing effect, holistic meditative effect, provocation of creative thoughts, induced hyperawareness of bodily states, and transitions from induced overstimulation or anxious thoughts to feelings of calmness. Conclusions: The preliminary findings of this study suggest that PA is a rich and complex form of visual art that has the potential to facilitate healing and promote well-being and mental health. PA presents promising avenues for integration into mental health care, therapeutic practices, digital health, health care environment, and medical research. UR - https://formative.jmir.org/2024/1/e66430 UR - http://dx.doi.org/10.2196/66430 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/66430 ER - TY - JOUR AU - Emezue, Chuka AU - Dan-Irabor, Dale AU - Froilan, Andrew AU - Dunlap, Aaron AU - Zamora, Pablo AU - Negron, Sarah AU - Simmons, Janiya AU - Watkins, Jayla AU - Julion, A. Wrenetha AU - Karnik, S. Niranjan PY - 2024/11/26 TI - Evaluating an App-Based Intervention for Preventing Firearm Violence and Substance Use in Young Black Boys and Men: Usability Evaluation Study JO - JMIR Form Res SP - e60918 VL - 8 KW - telemedicine KW - mobile app KW - adolescent KW - violence KW - substance-related disorder KW - African American KW - user-computer interface KW - software validation KW - software development KW - mobile phone N2 - Background: Young Black male individuals are 24 times more likely to be impacted by firearm injuries and homicides but encounter significant barriers to care and service disengagement, even in program-rich cities across the United States, leaving them worryingly underserved. Existing community-based interventions focus on secondary and tertiary prevention after firearm violence has occurred and are typically deployed in emergency settings. To address these service and uptake issues, we developed BrotherlyACT?a nurse-led, culturally tailored, multicomponent app?to reduce the risk and effects of firearm injuries and homicides and to improve access to precrisis and mental health resources for young Black male individuals (aged 15-24 years) in low-resource and high-violence settings. Grounded in Acceptance and Commitment Therapy, the app provides life skills coaching, safety planning, artificial intelligence?powered talk therapy, and zip code?based service connections directly to young Black male individuals at risk for violence and substance use. Objective: The primary aim of this study is to evaluate the usability, engagement, and satisfaction of BrotherlyACT among target young Black male users and mobile health (mHealth) experts, using a combination of formative usability testing (UT) and heuristic evaluation (HE). Methods: Using a convergent mixed methods approach, we evaluated the BrotherlyACT app using HE by 8 mHealth specialists and conducted UT with 23 participants, comprising 15 young Black male users (aged 15-24 years), alongside 4 adult internal team testers and 4 high school students who were part of our youth advisory board. UT included the System Usability Scale and thematic analysis of think-aloud interviews and cognitive walkthroughs. HE involved mHealth experts applying the Nielsen severity rating scale (score 0-3, with 3 indicating a major issue). All testing was conducted via REDCap (Research Electronic Data Capture) and Zoom or in person. Results: Qualitative usability issues were categorized into 8 thematic groups, revealing only minor usability concerns. The app achieved an average System Usability Scale score of 79, equivalent to an A-minus grade and placing it in the 85th percentile, indicating near-excellent usability. Similarly, the HE by testers identified minor and cosmetic usability issues, with a median severity score of 1 across various heuristics (on a scale of 0-3), indicating minimal impact on user experience. Overall, minor adjustments were recommended to enhance navigation, customization, and guidance for app users, while the app?s visual and functional design was generally well received. Conclusions: BrotherlyACT was considered highly usable and acceptable. Testers in the UT stage gave the app a positive overall rating and emphasized that several key improvements were made. Findings from our UT prompted revisions to the app prototype. Moving forward, a pilot study with a pretest-posttest design will evaluate the app?s efficacy in community health and emergency care settings. International Registered Report Identifier (IRRID): RR2-10.2196/43842 UR - https://formative.jmir.org/2024/1/e60918 UR - http://dx.doi.org/10.2196/60918 UR - http://www.ncbi.nlm.nih.gov/pubmed/39589765 ID - info:doi/10.2196/60918 ER - TY - JOUR AU - Malandrone, Francesca AU - Urru, Sara AU - Berchialla, Paola AU - Rossini, Gilbert Pierre AU - Oliva, Francesco AU - Bianchi, Silvia AU - Ottaviano, Manuel AU - Gonzalez-Martinez, Sergio AU - Carli, Vladimir AU - Valenza, Gaetano AU - Scilingo, Pasquale Enzo AU - Carletto, Sara AU - Ostacoli, Luca PY - 2024/11/21 TI - Exploring the Effects of Variety and Amount of Mindfulness Practices on Depression, Anxiety, and Stress Symptoms: Longitudinal Study on a Mental Health?Focused eHealth System for Patients With Breast or Prostate Cancer JO - JMIR Ment Health SP - e57415 VL - 11 KW - depression KW - anxiety KW - stress KW - internet-based KW - mental health KW - mindfulness KW - breast cancer KW - prostate cancer KW - cancer-related mental distress KW - emotional distress KW - psychological distress KW - mindfulness-based interventions KW - MBI KW - e-MBI KW - dispositional mindfulness KW - self-compassion KW - mental wellbeing KW - mobile phone N2 - Background: Patients with cancer often face depression and anxiety, and mindfulness-based interventions, including internet-based versions, can effectively reduce these symptoms and improve their quality of life. This study aims to investigate the impact of internet-based mindfulness-based interventions (e-MBIs) on anxiety, depression, and stress symptoms in patients with prostate or breast cancer. Objective: The primary aims are to assess the association between the amount and variety of e-MBI practices and symptom reduction. Second, this study aims to examine how baseline information such as sociodemographic characteristics, dispositional mindfulness (DM), and dispositional self-compassion (DSC) correlate with both app usage and symptom reduction. Methods: Participants included 107 patients with cancer (68 women with breast cancer and 38 men with prostate cancer) enrolled in a hospital setting. They were assigned to the intervention group of the NEVERMIND project, using the e-BMI module via the NEVERMIND app. A longitudinal design involved Pearson correlation analysis to determine the relationship between the amount and duration of e-MBI practices. Linear regression analysis was conducted to gauge the dose-response effect, evaluating the impact of DM and DSC on depression, anxiety, and stress. Negative binomial regression was conudcted to study sociodemographic factors? influence on the amount of practice in e-MBIs. Results: The participants with more diverse and sustained mindfulness practices experienced significant reductions in depression, anxiety, and stress. A high correlation (0.94) between e-MBI practices and symptom reduction was also highlighted. Male, married, and highly educated patients were more likely to engage in mindfulness. Even if DM and DSC did not impact the amount or variety of practices correlated, they were correlated with symptom reduction, showing that higher levels were associated with significant reductions in depression, anxiety, and stress. Conclusions: While more e-MBI practice is linked to reduced anxiety, depression, and stress, this study emphasizes the crucial role of variety of practice over amount. DM and DSC are key in shaping intervention effectiveness and may act as protectors against psychological distress. Using app log data, our research provides a unique perspective on e-MBI impact, contributing to cancer care understanding and guiding future studies. UR - https://mental.jmir.org/2024/1/e57415 UR - http://dx.doi.org/10.2196/57415 ID - info:doi/10.2196/57415 ER - TY - JOUR AU - Wiita, Farah AU - Ho, K. Aileen AU - Weinstein, Netta PY - 2024/11/21 TI - Web-Based Intervention Using Self-Compassionate Writing to Induce Positive Mood in Family Caregivers of Older Adults: Quantitative Study JO - JMIR Form Res SP - e52883 VL - 8 KW - self-compassion KW - caregivers KW - mindfulness KW - intervention KW - writing KW - experimental N2 - Background: Caregiver burden can impact the mental health of family caregivers, but self-compassion may help reduce this impact. Brief self-compassion interventions have been shown to be useful but have not been tested in family caregivers of older adults. Objective: This study aimed to test the effects of a brief self-compassion intervention and its components (self-kindness, common humanity, and mindfulness) on mental well-being and mood when reflecting on difficult family caregiving experiences. Methods: British caregivers were recruited through a web-based panel. Three experimental studies manipulated the self-compassion intervention. In study 1 (n=206) and study 2 (n=224), participants wrote about a difficult caregiving experience while focusing on 1 self-compassion component (self-kindness, common humanity, or mindfulness). In study 3 (n=222) participants focused on all components. Self-compassion, serenity, guilt, and sadness were measured. Results: In studies 1 and 2, condition effects showed mindfulness unexpectedly lowered mood. Inconsistent and modest benefits to affect were achieved by engagement in self-kindness and common humanity in study 1 (guilt [lowered]: P=.02 and sadness [lowered]: P=.04; serenity [nonsignificantly raised]: P=.20) and also in study 2 (sadness [nonsignificantly lowered]: P=.23 and guilt [nonsignificantly lowered]: P=.26; serenity [raised]: P=.33); significant benefits for self-compassion and mood were found in study 3 (serenity [raised]: P=.01, kindness [raised]: P=.003, and common humanity [raised]: P?.001; guilt [lowered]: P<.001 and sadness [lowered]: P?.001). More intensive efforts should be made to promote self-compassion in caregivers of older adults, with caution advised when relying primarily on mindfulness approaches. Conclusions: Self-compassionate writing may be beneficial for family caregivers, but more intensive interventions are needed. Further research is needed to determine the optimal dosage and content for achieving the greatest effects. UR - https://formative.jmir.org/2024/1/e52883 UR - http://dx.doi.org/10.2196/52883 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/52883 ER - TY - JOUR AU - Mace, A. Ryan AU - Law, E. Makenna AU - Cohen, E. Joshua AU - Ritchie, S. Christine AU - Okereke, I. Olivia AU - Hoeppner, B. Bettina AU - Brewer, A. Judson AU - Bartels, J. Stephen AU - Vranceanu, Ana-Maria AU - PY - 2024/11/21 TI - A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial JO - JMIR Res Protoc SP - e64149 VL - 13 KW - lifestyle KW - cognitive decline KW - brain health KW - mindfulness KW - mind-body therapies KW - telemedicine KW - digital health KW - randomized clinical trial N2 - Background: Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer disease and Alzheimer disease?related dementias (AD/ADRD). We are iteratively developing and testing My Healthy Brain (MHB), the first mindfulness-based lifestyle group program targeting AD/ADRD risk factors in older adults with subjective cognitive decline. Our pilot studies (National Institutes of Health [NIH] stage 1A) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes. Objective: We will compare the feasibility of MHB versus an education control (health enhancement program [HEP]) in 50 older adults (aged ?60 y) with subjective cognitive decline and AD/ADRD risk factors. In an NIH stage 1B randomized controlled trial (RCT), we will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms. Methods: We are recruiting through clinics, flyers, web-based research platforms, and community partnerships. Participants are randomized to MHB or the HEP, both delivered in telehealth groups over 8 weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Assessments are repeated after the intervention and at a 6-month follow-up. Our primary outcomes are feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity benchmarks. The secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol and tobacco use, and mental and social activity) behaviors. Data analyses will include the proportion of MHB and HEP participants who meet each benchmark (primary outcome) and paired samples 2-tailed t tests, Cohen d effect sizes, and the minimal clinically important difference for each measure (secondary outcomes). Results: Recruitment began in January 2024. We received 225 inquiries. Of these 225 individuals, 40 (17.8%) were eligible. Of the 40 eligible participants, 21 (52.5%) were enrolled in 2 group cohorts, 17 (42.5%) were on hold for future group cohorts, and 2 (5%) withdrew before enrollment. All participants have completed before the intervention assessments. All cohort 1 participants (9/21, 43%) have completed either MHB or the HEP (?6 of 8 sessions) and after the intervention assessments. The intervention for cohort 2 (12/21, 57%) is ongoing. Adherence rates for the Garmin Vivosmart 5 (128/147, 87.1% weeks) and daily surveys (105/122, 86.1% weeks) are high. No enrolled participants have dropped out. Enrollment is projected to be completed by December 2024. Conclusions: The RCT will inform the development of a larger efficacy RCT (NIH stage 2) of MHB versus the HEP in a more diverse sample of older adults, testing mechanisms of improvements through theoretically driven mediators and moderators. The integration of mindfulness with lifestyle behavior change in MHB has the potential to be an effective and sustainable approach for increasing the uptake of AD/ADRD risk reduction strategies among older adults. Trial Registration: ClinicalTrials.gov NCT05934136; https://www.clinicaltrials.gov/study/NCT05934136 International Registered Report Identifier (IRRID): DERR1-10.2196/64149 UR - https://www.researchprotocols.org/2024/1/e64149 UR - http://dx.doi.org/10.2196/64149 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64149 ER - TY - JOUR AU - Becker, Elizabeth Molly AU - Stratton Levey, Nadine AU - Yeh, Y. Gloria AU - Giacino, Joseph AU - Iverson, Grant AU - Silverberg, Noah AU - Parker, A. Robert AU - McKinnon, Ellen AU - Siravo, Caitlin AU - Shah, Priyanca AU - Vranceanu, Ana-Maria AU - Greenberg, Jonathan PY - 2024/11/8 TI - Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study JO - JMIR Form Res SP - e64540 VL - 8 KW - concussions KW - mind-body KW - preventions KW - young adults KW - feasibility KW - persistence KW - open pilot KW - mind-body program KW - preliminary feasibility KW - mild traumatic brain injuries KW - United States KW - adults KW - psychological factors KW - mind-body interventions N2 - Background: Concussions are common, particularly among young adults, and often are associated with persistent, debilitating, and hard-to-treat symptoms. Anxiety and concussion symptoms often amplify each other, and growing evidence indicates that anxiety plays a key role in symptoms persistence after concussion. Targeting anxiety early after concussion may be a promising means of helping prevent persistent concussion symptoms in this population. We developed the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program tailored for young adults with a recent concussion and anxiety, aiming to prevent persistent concussion symptoms. Objective: This study aims to conduct an open pilot of TOR-C to test preliminary feasibility, signal of change in measures, and treatment perceptions. Methods: Five young adults (aged 18-24 years) attended 4 weekly one-on-one live video sessions with a clinician. Participants completed questionnaires measuring treatment targets (ie, pain catastrophizing, mindfulness, fear avoidance, limiting behaviors, and all-or-nothing behaviors) and outcomes (ie, postconcussive symptoms, physical function, anxiety, depression, and pain) at baseline, immediately following the intervention, and 3 months after intervention completion. At the conclusion of the program, participants attended a qualitative interview and provided feedback about the program to help optimize study content and procedures. Results: Feasibility markers were excellent for credibility and expectancy (5/5, 100% of participants scored above the credibility and expectancy scale midpoint), client satisfaction (4/5, 80% of participants scored above the Client Satisfaction Questionnaire midpoint), therapist adherence (97% adherence), acceptability of treatment (5/5, 100% of participants attended 3 or more sessions), adherence to homework (87% home practice completion), and feasibility of assessments (no measures fully missing). The feasibility of recruitment was good (5/7, 71% of eligible participants agreed to participate). There were preliminary signals of improvements from pre-post comparisons in treatment targets (d=0.72-2.20) and outcomes (d=0.41-1.38), which were sustained after 3 months (d=0.38-2.74 and d=0.71-1.63 respectively). Exit interviews indicated overall positive perceptions of skills and highlighted barriers (eg, busyness) and facilitators (eg, accountability) to engagement. Conclusions: TOR-C shows preliminary feasibility, is associated with a signal of improvement in treatment targets and outcomes, and has the potential to support recovery from concussion. The quantitative findings along with the qualitative feedback obtained from the exit interviews will help optimize TOR-C in preparation for an upcoming randomized controlled trial of TOR-C versus an active control condition of health education for concussion recovery. International Registered Report Identifier (IRRID): RR2-10.2196/25746 UR - https://formative.jmir.org/2024/1/e64540 UR - http://dx.doi.org/10.2196/64540 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64540 ER - TY - JOUR AU - Yatziv, Shai-Lee AU - Pedrelli, Paola AU - Baror, Shira AU - DeCaro, Ann Sydney AU - Shachar, Noam AU - Sofer, Bar AU - Hull, Sunday AU - Curtiss, Joshua AU - Bar, Moshe PY - 2024/11/7 TI - Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial JO - J Med Internet Res SP - e56201 VL - 26 KW - depression KW - cognitive neuroscience KW - facilitating thought progression KW - FTP KW - mobile phone KW - digital health KW - gamification KW - depression symptoms KW - randomized controlled trial KW - RCT KW - app KW - depressive disorder KW - web-based platforms KW - effectiveness N2 - Background: The constant rise in the prevalence of major depressive disorder calls for new, effective, and accessible interventions that can rapidly and effectively reach a wide range of audiences. Recent developments in the digital health domain suggest that dedicated online platforms may potentially address this gap. Focusing on targeting ruminative thought, a major symptomatic hallmark of depression, in this study we hypothesized that delivering a digital health?based intervention designed to systematically facilitate thought progression would substantially alleviate depression. Objective: The study aims to investigate the efficacy of a novel digital intervention on the reduction of depressive symptoms. This intervention was designed as an easy-to-use gamified app specifically aimed to facilitate thought progression through intense practicing of associative, semantically broad, fast, and creative thought patterns. Methods: A randomized clinical trial was conducted, comparing changes in depression symptoms between participants who used the app in the intervention group (n=74) and waitlist control group (n=27) over the course of 8 weeks. All participants filled out a battery of clinical questionnaires to assess the severity of depression at baseline and 4 and 8 weeks after starting the study. These primarily included the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire-9 as well as the Positive Affect Negative Affect Scale-Negative Affect Score, Ruminative Response Scale, and Symptoms of Depression Questionnaire. Additional questionnaires were implemented to assess anxiety, positive affect, anhedonia, and quality of life. Results: The results indicate that across multiple clinical measurements, participants in the intervention group who played the gamified app showed greater and faster improvement in depressive symptoms compared with their waitlist control counterparts. The difference between the groups in MADRS improvement was ?7.01 points (95% CI ?10.72 to ?3.29; P<.001; Cohen d=0.67). Furthermore, the difference in improvement between groups persisted up to 4 weeks posttrial (MADRS differences at week 12: F49,2=6.62; P=.003; ?p2=0.21). At the end of the trial, participants who played the app showed high interest in continuing using the app. Conclusions: The results demonstrate that a gamified app designed to facilitate thought progression is associated with improvement in depressive symptoms. Given its innovative and accessibility features, this gamified method aiming to facilitate thought progression may successfully complement traditional treatments for depression in the future, providing a safe and impactful way to enhance the lives of individuals experiencing depression and anxiety. Trial Registration: ClinicalTrials.gov NCT05685758; https://clinicaltrials.gov/study/NCT05685758 UR - https://www.jmir.org/2024/1/e56201 UR - http://dx.doi.org/10.2196/56201 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56201 ER - TY - JOUR AU - Larson, Elizabeth AU - Mattie, L. Rebecca AU - Riffkin, A. Sophia PY - 2024/10/31 TI - Assessment of Acceptability, Usage, and Impact on Caregivers of Children With Autism?s Stress and Mindfulness: Multiple-Method Feasibility Study of the 5Minutes4Myself App?s Mindfulness Module JO - JMIR Hum Factors SP - e54171 VL - 11 KW - autism KW - caregiver KW - activities KW - mindfulness KW - mobile application KW - stress KW - wellness KW - app KW - application KW - usage KW - children KW - developmental disability KW - usability KW - acceptability KW - meditation KW - wellness application N2 - Background: Caregiver wellness programs need to be easily accessible to address caregivers? constraints to participation. Objective: We aimed to assess the feasibility of 5Minutes4Myself app?s mindfulness module (usability, usage, and impact on caregivers? levels of mindfulness and perceived stress). Methods: Before and after participation in the 5Minutes4Myself program, 15 participants were asked to complete the Perceived Stress Scale (PSS) and Five Facet Mindfulness Questionnaire (FFMQ). Data on the usage of app-delivered meditations were collected electronically via the app, and app usability was rated on the Modified System Usability Scale. Analyses assessed participants? frequency of use of app-delivered meditations, app usability, and changes in participants? stress and mindfulness post intervention. Results: Overall, participants completed 10.9 minutes of mindfulness meditations per week and rated the app 76.7, indicating above-average usability. Related samples t tests (2-tailed) found that group PSS (t10=1.20, P=.26) and FFMQ (t10=?1.57, P=.15) pre- or postintervention mean scores were not significantly different. However, a visualization of pre- and post-PSS and mindfulness scores suggested there was a group of responders who had decreased stress with increased mindfulness. This was confirmed via an individual change analysis. The effect size of the FFMQ scores (d=0.47) suggests there may be treatment effects with a larger sample. A hierarchical multiple regression analysis examined the degree mindfulness impacted perceived stress; 20% of the variance in participants? perceived stress could be attributed to increases in self-rated mindfulness (P=.04) when controlling for preintervention stress levels. Conclusions: Caregivers found the app highly usable and on average used low-dose levels of mindfulness meditations (10 min/wk). For responders, increased mindfulness was related to stress reduction to population-based levels. Trial Registration: ClinicalTrials.gov NCT03771001; https://clinicaltrials.gov/study/NCT03771001 UR - https://humanfactors.jmir.org/2024/1/e54171 UR - http://dx.doi.org/10.2196/54171 ID - info:doi/10.2196/54171 ER - TY - JOUR AU - Dantes, Rasben Gede AU - Asril, Maylani Nice AU - Liem, Andrian AU - Suwastini, Arie Ni Komang AU - Keng, Shian-Ling AU - Mahayanti, Surya Ni Wayan PY - 2024/10/23 TI - Brief Mobile App?Based Mindfulness Intervention for Indonesian Senior High School Teachers: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e56693 VL - 13 KW - digital mental health KW - telemedicine KW - anxiety KW - stress KW - self-efficacy KW - life satisfaction KW - self-compassion KW - mindfulness KW - feasibility study KW - mobile app KW - mindfulness-based stress reduction KW - stress management N2 - Background: The COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app. Objective: The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness?based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants. Methods: We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers? Sense of Efficacy Scale (TSES), the Self-Compassion Scale?Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations. Results: Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry. Conclusions: This study aims to determine the feasibility and efficacy of the BM-MA, a digital mental health intervention developed using an existing mindfulness-based app, and assess its potential for widespread use. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068085; https://tinyurl.com/2d2x4bxk International Registered Report Identifier (IRRID): DERR1-10.2196/56693 UR - https://www.researchprotocols.org/2024/1/e56693 UR - http://dx.doi.org/10.2196/56693 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56693 ER - TY - JOUR AU - Aubert, Morghane AU - Clavel, Céline AU - Le Scanff, Christine AU - Martin, Jean-Claude PY - 2024/10/15 TI - Intervention to Improve Well-Being, Nutrition, and Physical Activity in Adults: Experimental Study JO - JMIR Form Res SP - e47251 VL - 8 KW - mindfulness KW - well-being KW - affects KW - nutrition KW - physical activity KW - intervention KW - lifestyle habits KW - mindfulness exercises N2 - Background: Mindfulness improves well-being, improves emotional regulation, reduces impulses to eat, and is linked to increased physical activity. Mindfulness interventions usually focus on 1 aspect but do not offer an approach to holistically improving lifestyle. Objective: This study aims to address this gap by designing and evaluating a holistic mindfulness intervention. Methods: Committing to a 12-week intervention with 2-hour sessions without knowing whether you will enjoy it can be a hindrance for someone completely unfamiliar with mindfulness. For this reason, we decided to design a mindfulness intervention with short sessions over a reduced number of weeks. The aim is to enable novices to discover different aspects of mindfulness while at the same time offering a satisfactory practice for people who are already practicing mindfulness. We designed and evaluated a web-based mindfulness intervention in 5 sessions of 5 to 10 minutes each on well-being, diet, and physical activity to support a healthier lifestyle. The first 2 sessions focus on formal mindfulness meditation to enable novices to discover mindfulness and its main principles. Then there are 2 sessions about food. The first session about food aims to develop a sense of satisfaction with the food we eat and to focus our attention on new sensations. The second session about food aims to develop the ability to resist the lure of unhealthy foods. Finally, there is a session on physical activity. The aim is to develop a particular awareness of the body during movement, to increase satisfaction with physical activity, and to develop regular exercise. Results: In total, 32 participants completed the intervention. After the intervention, we observed decreases in negative affect, anxiety, and emotional distress, and an increase in dispositional mindfulness. There was no effect on reported healthy eating habits and physical activity habits. Few participants repeated the exercises as recommended. The majority of our participants were new to mindfulness. The majority of our participants reported being satisfied with the different sessions. A few minor difficulties were mentioned, mainly related to the environment in which the participants carried out the sessions. Only 1 session was less satisfactory for one-third of the participants. The session on resistance to unhealthy foods was formulated too strictly and the idea of banning certain foods was a hindrance for one-third of the participants. A reformulation is needed. Conclusions: The mindfulness exercises were well accepted and promoted a state of mindfulness. It would be interesting to provide easier technical access to the exercises via a mobile app so that they can be repeated easily. UR - https://formative.jmir.org/2024/1/e47251 UR - http://dx.doi.org/10.2196/47251 UR - http://www.ncbi.nlm.nih.gov/pubmed/39405102 ID - info:doi/10.2196/47251 ER - TY - JOUR AU - Travis, Aniyah AU - O?Donnell, Arden AU - Giraldo-Santiago, Natalia AU - Stone, M. Sarah AU - Torres, Daniel AU - Adler, R. Shelley AU - Vranceanu, Ana-Maria AU - Ritchie, S. Christine PY - 2024/10/11 TI - Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia JO - JMIR Res Protoc SP - e58356 VL - 13 KW - mindfulness KW - caregiver KW - self-compassion KW - ADRD KW - Alzheimer?s disease and related dementias KW - mental health N2 - Background: Stress related to Alzheimer disease and related dementias (ADRD) is common, particularly among those who care for persons with challenging behaviors and personality or mood changes. Mindfulness and self-compassion programs are efficacious for managing stress. The skills of mindfulness and self-compassion, however, must be integrated with behavioral management skills in order to effectively improve caregiver stress. Objective: In this study, we aimed to describe the development of the Mindful and Self-Compassionate Care (MASC) program, the first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress, and its evaluation in the Supporting Our Caregivers in ADRD Learning (SOCIAL) study. Methods: Using the National Institutes of Health (NIH) stage model, we describe 3 phases of work encompassing NIH Stages 1A and 1B. In phase 1, we conducted 5 focus groups (N=28) of stressed individuals caring for persons with ADRD and challenging behaviors. Rapid data analysis informed the development of a 6-week online intervention. Phase 2 (NIH stage 1A) includes an open pilot (N>10) with optional exit interviews. Phase 3 (NIH stage 1B) is a feasibility randomized controlled trial of the intervention versus the Health Education Program control. Primary outcomes focus on feasibility with secondary outcomes encompassing acceptability, credibility, fidelity, and signals of preliminary efficacy. Phase 1 follows traditional recommendations for qualitative analyses (at the point of thematic saturation) which was achieved after 5 focus groups (N=28). For the phase 2 open pilot, up to 12 participants will be recruited. For the phase 3 feasibility study, recruitment of 80 caregivers will allow the assessment of feasibility benchmarks. Data for phase 1 included 5 focus groups. In phases 2 and 3, data collection will occur through REDCap (Research Electronic Data Capture; Vanderbilt University) surveys and an optional qualitative exit interview. Analyses will include hybrid inductive-deductive analyses for qualitative data and assessment of changes in our intervention targets and outcomes using t tests and correlation analyses. Results: In phase 1, caregivers reported interest in a brief, online stress management program. Participants held misconceptions about mindfulness and self-compassion, but after detailed explanation thoughts, these skills could be helpful when directly linked to implementation during caregiving routines. Phases 2 and 3 will be completed by the end of 2025. Conclusions: We describe the protocol for the Supporting Our Caregivers in ADRD Learning study, as well as the development and feasibility testing of the Mindful and Self-Compassionate Care intervention. Future work will include a fully powered efficacy-effectiveness randomized controlled trial. Trial Registration: ClinicalTrials NCT05847153; https://clinicaltrials.gov/study/NCT05847153; and ClinicalTrials.gov NCT06276023; https://clinicaltrials.gov/study/NCT06276023 International Registered Report Identifier (IRRID): DERR1-10.2196/58356 UR - https://www.researchprotocols.org/2024/1/e58356 UR - http://dx.doi.org/10.2196/58356 UR - http://www.ncbi.nlm.nih.gov/pubmed/39392675 ID - info:doi/10.2196/58356 ER - TY - JOUR AU - Puah, Shermain AU - Pua, Yee Ching AU - Shi, Jing AU - Lim, Mui Sok PY - 2024/10/7 TI - The Effectiveness of a Digital Mental Fitness Program (Positive Intelligence) on Perceived Stress, Self-Compassion, and Ruminative Thinking of Occupational Therapy Undergraduate Students: Longitudinal Study JO - J Med Internet Res SP - e49505 VL - 26 KW - mental health KW - students KW - digital wellness KW - mobile health (mHealth) KW - perceived stress KW - self-compassion KW - rumination N2 - Background: Health care students often endure numerous stressors throughout their undergraduate education that can have lasting negative effects on their mental well-being. Positive Intelligence (PQ) is a digital mental fitness program designed to enhance self-mastery and help individuals reach their potential by strengthening various ?mental muscles.? Objective: This study aims to evaluate the effectiveness of a 6-week app-delivered PQ program in reducing perceived stress, increasing self-compassion, and decreasing rumination tendencies among health care undergraduates. We hypothesized that students would show reductions in perceived stress, increases in self-compassion, and decreases in rumination tendencies by the end of the PQ program, compared with their preprogram scores. We adopted an exploratory approach for the 5-month follow-up due to the limited research consensus on the sustained effects of app-based programs over varying periods. Methods: The PQ program includes weekly hour-long videos, weekly group meetings, and daily 15-minute app-guided practices. Participants were first-year students from the occupational therapy program at a university in Singapore. Participants completed surveys measuring self-compassion, perceived stress, and rumination levels before and after the PQ program, and again at a 5-month follow-up. Data were analyzed using repeated measures ANOVA to assess differences across the pretest, immediate posttest, and follow-up posttest. Results: Out of 87 students enrolled in the study, the final sample consisted of 64 students (n=47, 73%, female; mean age 23 years, SD 5.06 years) with complete data. At the end of the 6 weeks, students exhibited significant increases in self-compassion (before the intervention: mean 3.07, SD 0.35; after the intervention: mean 3.34, SD 0.35; P<.001) and reductions in rumination tendencies (before the intervention: mean 3.57, SD 0.40; after the intervention: mean 3.27, SD 0.34; P<.001). However, no significant change in perceived stress levels was observed (before the intervention: 2.99, SD 0.14; after the intervention: mean 2.97, SD 0.16; P=.50). These effects were not influenced by the daily app-based practice of PQ exercises, and there were no sustained effects on self-compassion (mean 3.17, SD 0.27; P=.09) or rumination tendencies (mean 3.42, SD 0.38; P=.06) at the 5-month follow-up. Additionally, there was a significant increase in perceived stress at follow-up (mean 3.17, SD 0.21; P<.001) compared with pre- and postintervention levels. Conclusions: The PQ program did not directly alter stress perceptions but may have reframed students? automatic negative thought processes, increased their awareness of self-sabotaging behaviors, and enhanced their self-compassion while reducing ruminative thinking. These findings highlight the importance of self-awareness for students? well-being. Students can benefit from practices such as mindfulness and peer discussions to enhance self-compassion and reduce rumination. Educators trained in the PQ program can foster a supportive environment that encourages self-compassion, challenges negative self-talk, and helps students manage stress. UR - https://www.jmir.org/2024/1/e49505 UR - http://dx.doi.org/10.2196/49505 UR - http://www.ncbi.nlm.nih.gov/pubmed/39374067 ID - info:doi/10.2196/49505 ER - TY - JOUR AU - Jackson, Walton Riley AU - Cao-Nasalga, Ann AU - Chieng, Amy AU - Pirkl, Amy AU - Jagielo, D. Annemarie AU - Xu, Cindy AU - Goldenhersch, Emilio AU - Rosencovich, Nicolas AU - Waitman, Cristian AU - Prochaska, J. Judith PY - 2024/7/23 TI - Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center?s Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study JO - JMIR Form Res SP - e54817 VL - 8 KW - tobacco cessation KW - virtual reality KW - exposure therapy KW - cancer care KW - mobile phone N2 - Background: Smoking contributes to 1 in 3 cancer deaths. At the Stanford Cancer Center, tobacco cessation medication management and counseling are provided as a covered benefit. Patients charted as using tobacco are contacted by a tobacco treatment specialist and offered cessation services. As a novel addition, this study examined the acceptability of a virtual reality (VR) mindful exposure therapy app for quitting smoking called MindCotine. Objective: The objective of this study was to determine the feasibility and acceptability of offering 6 weeks of MindCotine treatment as a part of Stanford?s Tobacco Treatment Services for patients seen for cancer care. Methods: As part of a single-group pilot study, the MindCotine VR program was offered to English- or Spanish-speaking patients interested in quitting smoking. Given the visual interface, epilepsy was a medical exclusion. Viewed from a smartphone with an attachable VR headset, MindCotine provides a digital environment with audiovisual content guiding mindfulness exercises (eg, breathing techniques, body awareness, and thought recognition), text-based coaching, and cognitive behavioral therapy-based self-reflections for quitting smoking. Interested patients providing informed consent were mailed a MindCotine headset and asked to use the app for 10+ minutes a day. At the end of 6 weeks, participants completed a feedback survey. Results: Of the 357 patients reached by the tobacco treatment specialist, 62 (17.3%) were ineligible, 190 (53.2%) were not interested in tobacco treatment services, and 78 (21.8%) preferred other tobacco treatment services. Among the 105 eligible and interested in assistance with quitting, 27 (25.7%) were interested in MindCotine, of whom 20 completed the informed consent, 9 used the program, and 8 completed their end-of-treatment survey. Participants using MindCotine completed, on average, 13 (SD 20.2) program activities, 19 (SD 26) journal records, and 11 (SD 12.3) coaching engagements. Of the 9 participants who used MindCotine, 4 (44%) reported some dizziness with app use that resolved and 7 (78%) would recommend MindCotine to a friend. In total, 2 participants quit tobacco (22.2% reporting, 10% overall), 2 others reduced their smoking by 50% or more, and 2 quit for 24 hours and then relapsed. Conclusions: In a feasibility and acceptability pilot study of a novel VR tobacco treatment app offered to patients at a cancer center, 4 of 9 (44%) reporting and 4 of 20 (20%) overall substantially reduced or quit using tobacco after 6 weeks and most would recommend the app to others. Further testing on a larger sample is warranted. Trial Registration: ClinicalTrials.gov NCT05220254; https://clinicaltrials.gov/study/NCT05220254 UR - https://formative.jmir.org/2024/1/e54817 UR - http://dx.doi.org/10.2196/54817 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54817 ER - TY - JOUR AU - Wang, Ting AU - Tang, Chulei AU - Jiang, Xiaoman AU - Guo, Yinning AU - Zhu, Shuqin AU - Xu, Qin PY - 2024/6/25 TI - Effectiveness of Web-Based Mindfulness-Based Interventions for Patients With Cancer: Systematic Review and Meta-Analyses JO - J Med Internet Res SP - e47704 VL - 26 KW - cancer KW - mindfulness-based interventions KW - mental health KW - randomized controlled trial KW - systematic review KW - meta-analysis KW - mindfulness KW - web-based intervention KW - oncology KW - delivery mode KW - efficacy KW - quality of life KW - program KW - adherence KW - mobile phone N2 - Background: Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown. Objective: This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings. Methods: Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ?18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings. Results: Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD ?0.36, 95% CI ?0.71 to ?0.01; P=.04), anxiety (SMD ?0.48, 95% CI ?0.75 to ?0.20; P<.001), depression (SMD ?0.36, 95% CI ?0.61 to ?0.11; P=.005), distress (SMD ?0.50, 95% CI ?0.75 to ?0.26; P<.001), and perceived stress (SMD ?0.89, 95% CI ?1.33 to ?0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD ?0.30, 95% CI ?1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI ?0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer. Conclusions: App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms. Trial Registration: PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219 UR - https://www.jmir.org/2024/1/e47704 UR - http://dx.doi.org/10.2196/47704 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/47704 ER - TY - JOUR AU - Hooshmand Zaferanieh, Mohammad AU - Shi, Lu AU - Jindal, Meenu AU - Chen, Liwei AU - Zhang, Lingling AU - Lopes, Snehal AU - Jones, Karyn AU - Wang, Yucheng AU - Meggett, Kinsey AU - Walker, Beth Cari AU - Falgoust, Grace AU - Zinzow, Heidi PY - 2024/6/18 TI - Web-Based Mindfulness-Based Cognitive Therapy for Adults With a History of Depression: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e53966 VL - 13 KW - mindfulness-based cognitive therapy KW - MBCT KW - mindfulness-based interventions KW - depression KW - depressive symptoms KW - virtual delivery KW - mindfulness KW - mental health KW - depressive KW - distress KW - stress KW - remote KW - randomized KW - controlled trial KW - controlled trials KW - RCT KW - psychotherapy KW - cognitive therapy N2 - Background: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. Objective: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. Methods: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. Results: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. Conclusions: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT?s efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. Trial Registration: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719 International Registered Report Identifier (IRRID): DERR1-10.2196/53966 UR - https://www.researchprotocols.org/2024/1/e53966 UR - http://dx.doi.org/10.2196/53966 UR - http://www.ncbi.nlm.nih.gov/pubmed/38888958 ID - info:doi/10.2196/53966 ER - TY - JOUR AU - Kerry, Camrie AU - Mann, Prabhdeep AU - Babaei, Nazanin AU - Katz, Joel AU - Pirbaglou, Meysam AU - Ritvo, Paul PY - 2024/6/12 TI - Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial JO - JMIR Ment Health SP - e55283 VL - 11 KW - body dysmorphic disorder KW - BDD KW - dysmorphophobia KW - obsessive-compulsive and related disorders KW - OCD KW - internet-delivered cognitive behavior therapy KW - iCBT KW - cognitive behavior therapy KW - mindfulness-based cognitive therapy KW - mindfulness KW - eMental health KW - randomized controlled trial N2 - Background: Internet-based cognitive behavioral therapy (CBT) and stand-alone mindfulness meditation interventions are gaining empirical support for a wide variety of mental health conditions. In this study, we test the efficacy of web-based therapist-guided mindfulness-based cognitive behavioral therapy (CBT-M) for body dysmorphic disorder (BDD), a psychiatric disorder characterized by preoccupations with perceived defects in appearance. Objective: This study aims to determine whether CBT-M for BDD delivered on the web is feasible and acceptable and whether mindfulness meditation adds to CBT treatment effects for BDD. Methods: In this 8-week, 2-arm, parallel pilot randomized controlled trial, n=28 adults (aged between 18 and 55 years) were randomly allocated to an experimental group (web-based therapist-guided CBT-M) or a control group (web-based therapist-guided CBT). Study retention, accrual, and intervention adherence were assessed, along with self-report measures for BDD, depression, anxiety, and pain intensity taken at baseline and postintervention. Results: This study was feasible to implement and deemed acceptable by participants. After 8 weeks, significant improvements were found on all outcome measures for both treatment groups, and large between-group effect sizes favoring CBT-M were found for BDD symptom severity (d=?0.96), depression (d=?1.06), pain severity (d=?1.12), and pain interference (d=?1.28). However, linear mixed models demonstrated no significant differences between the groups over 8 weeks. Conclusions: The results suggest that mindfulness meditation may add to beneficial web-based CBT treatment effects for BDD. An adequately powered randomized control trial of web-based CBT-M is warranted. Trial Registration: ClinicalTrials.gov NCT05402475, http://clinicaltrials.gov/ct2/show/NCT05402475 UR - https://mental.jmir.org/2024/1/e55283 UR - http://dx.doi.org/10.2196/55283 UR - http://www.ncbi.nlm.nih.gov/pubmed/38865704 ID - info:doi/10.2196/55283 ER - TY - JOUR AU - Togo, Eiichi AU - Takami, Miki AU - Ishigaki, Kyoko PY - 2024/6/12 TI - Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device: Randomized Controlled Trial JO - JMIR Nursing SP - e56616 VL - 7 KW - mindfulness KW - sleep KW - cardiac potential KW - low frequency KW - high frequency KW - mobile phone N2 - Background: One issue to be considered in universities is the need for interventions to improve sleep quality and educational systems for university students. However, sleep problems remain unresolved. As a clinical practice technique, a mindfulness-based stress reduction method can help students develop mindfulness skills to cope with stress, self-healing skills, and sleep. Objective: We aim to verify the effectiveness of mindful breathing exercises using a tablet device. Methods: In total, 18 nursing students, aged 18-22 years, were randomly assigned and divided equally into mindfulness (Mi) and nonmindfulness (nMi) implementation groups using tablet devices. During the 9-day experimental period, cardiac potentials were measured on days 1, 5, and 9. In each sleep stage (sleep with sympathetic nerve dominance, shallow sleep with parasympathetic nerve dominance, and deep sleep with parasympathetic nerve dominance), low frequency (LF) value, high frequency (HF) value, and LF/HF ratios obtained from the cardiac potentials were evaluated. Results: On day 5, a significant correlation was observed between sleep duration and each sleep stage in both groups. In comparison to each experimental day, the LF and LF/HF ratios of the Mi group were significantly higher on day 1 than on days 5 and 10. LF and HF values in the nMi group were significantly higher on day 1 than on day 5. Conclusions: The correlation between sleep duration and each sleep stage on day 5 suggested that sleep homeostasis in both groups was activated on day 5, resulting in similar changes in sleep stages. During the experimental period, the cardiac potentials in the nMi group showed a wide range of fluctuations, whereas the LF values and LF/HF ratio in the Mi group showed a decreasing trend over time. This finding suggests that implementing mindful breathing exercises using a tablet device may suppress sympathetic activity during sleep. Trial Registration: UMIN-CTR Clinical Trials Registry UMIN000054639; https://tinyurl.com/mu2vdrks UR - https://nursing.jmir.org/2024/1/e56616 UR - http://dx.doi.org/10.2196/56616 UR - http://www.ncbi.nlm.nih.gov/pubmed/38865177 ID - info:doi/10.2196/56616 ER - TY - JOUR AU - Chandhiruthil Sathyan, Anjana AU - Yadav, Pramod AU - Gupta, Prashant AU - Mahapathra, Kumar Arun AU - Galib, Ruknuddin PY - 2024/6/10 TI - In Silico Approaches to Polyherbal Synergy: Protocol for a Scoping Review JO - JMIR Res Protoc SP - e56646 VL - 13 KW - polyherbal formulation KW - Ayurveda system KW - Ayurveda KW - Ayurvedic medicine KW - Ayurvedic treatment KW - herbal KW - herbal drug KW - pharmacodynamic KW - pharmacology KW - computer-aided drug design KW - in silico methodology KW - scoping review N2 - Background: According to the World Health Organization, more than 80% of the world?s population relies on traditional medicine. Traditional medicine is typically based on the use of single herbal drugs or polyherbal formulations (PHFs) to manage diseases. However, the probable mode of action of these formulations is not well studied or documented. Over the past few decades, computational methods have been used to study the molecular mechanism of phytochemicals in single herbal drugs. However, the in silico methods applied to study PHFs remain unclear. Objective: The aim of this protocol is to develop a search strategy for a scoping review to map the in silico approaches applied in understanding the activity of PHFs used as traditional medicines worldwide. Methods: The scoping review will be conducted based on the methodology developed by Arksey and O?Malley and the recommendations of the Joanna Briggs Institute (JBI). A set of predetermined keywords will be used to identify the relevant studies from five databases: PubMed, Embase, Science Direct, Web of Science, and Google Scholar. Two independent reviewers will conduct the search to yield a list of relevant studies based on the inclusion and exclusion criteria. Mendeley version 1.19.8 will be used to remove duplicate citations, and title and abstract screening will be performed with Rayyan software. The JBI System for the Unified Management, Assessment, and Review of Information tool will be used for data extraction. The scoping review will be reported based on the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Results: Based on the core areas of the scoping review, a 3-step search strategy was developed. The initial search produced 3865 studies. After applying filters, 875 studies were short-listed for further review. Keywords were further refined to yield more relevant studies on the topic. Conclusions: The findings are expected to determine the extent of the knowledge gap in the applications of computational methods in PHFs for any traditional medicine across the world. The study can provide answers to open research questions related to the phytochemical identification of PHFs, criteria for target identification, strategies applied for in silico studies, software used, and challenges in adopting in silico methods for understanding the mechanisms of action of PHFs. This study can thus provide a better understanding of the application and types of in silico methods for investigating PHFs. International Registered Report Identifier (IRRID): PRR1-10.2196/56646 UR - https://www.researchprotocols.org/2024/1/e56646 UR - http://dx.doi.org/10.2196/56646 UR - http://www.ncbi.nlm.nih.gov/pubmed/38857494 ID - info:doi/10.2196/56646 ER - TY - JOUR AU - Schläpfer, Sonja AU - Schneider, Fabian AU - Santhanam, Prabhakaran AU - Eicher, Manuela AU - Kowatsch, Tobias AU - Witt, M. Claudia AU - Barth, Jürgen PY - 2024/5/31 TI - Engagement With a Relaxation and Mindfulness Mobile App Among People With Cancer: Exploratory Analysis of Use Data and Self-Reports From a Randomized Controlled Trial JO - JMIR Cancer SP - e52386 VL - 10 KW - mobile health KW - mHealth KW - digital health KW - eHealth KW - smartphone KW - mobile phone KW - implementation KW - adherence KW - self-guided KW - unguided KW - fully automated KW - conversational agent KW - chatbot KW - behavior change KW - tailoring KW - self-care KW - cancer KW - app development N2 - Background: Mobile health (mHealth) apps offer unique opportunities to support self-care and behavior change, but poor user engagement limits their effectiveness. This is particularly true for fully automated mHealth apps without any human support. Human support in mHealth apps is associated with better engagement but at the cost of reduced scalability. Objective: This work aimed to (1) describe the theory-informed development of a fully automated relaxation and mindfulness app to reduce distress in people with cancer (CanRelax app 2.0), (2) describe engagement with the app on multiple levels within a fully automated randomized controlled trial over 10 weeks, and (3) examine whether engagement was related to user characteristics. Methods: The CanRelax app 2.0 was developed in iterative processes involving input from people with cancer and relevant experts. The app includes evidence-based relaxation exercises, personalized weekly coaching sessions with a rule-based conversational agent, 39 self-enactable behavior change techniques, a self-monitoring dashboard with gamification elements, highly tailored reminder notifications, an educational video clip, and personalized in-app letters. For the larger study, German-speaking adults diagnosed with cancer within the last 5 years were recruited via the web in Switzerland, Austria, and Germany. Engagement was analyzed in a sample of 100 study participants with multiple measures on a micro level (completed coaching sessions, relaxation exercises practiced with the app, and feedback on the app) and a macro level (relaxation exercises practiced without the app and self-efficacy toward self-set weekly relaxation goals). Results: In week 10, a total of 62% (62/100) of the participants were actively using the CanRelax app 2.0. No associations were identified between engagement and level of distress at baseline, sex assigned at birth, educational attainment, or age. At the micro level, 71.88% (3520/4897) of all relaxation exercises and 714 coaching sessions were completed in the app, and all participants who provided feedback (52/100, 52%) expressed positive app experiences. At the macro level, 28.12% (1377/4897) of relaxation exercises were completed without the app, and participants? self-efficacy remained stable at a high level. At the same time, participants raised their weekly relaxation goals, which indicates a potential relative increase in self-efficacy. Conclusions: The CanRelax app 2.0 achieved promising engagement even though it provided no human support. Fully automated social components might have compensated for the lack of human involvement and should be investigated further. More than one-quarter (1377/4897, 28.12%) of all relaxation exercises were practiced without the app, highlighting the importance of assessing engagement on multiple levels. UR - https://cancer.jmir.org/2024/1/e52386 UR - http://dx.doi.org/10.2196/52386 UR - http://www.ncbi.nlm.nih.gov/pubmed/38819907 ID - info:doi/10.2196/52386 ER - TY - JOUR AU - Schillings, Christine AU - Meißner, Echo AU - Erb, Benjamin AU - Bendig, Eileen AU - Schultchen, Dana AU - Pollatos, Olga PY - 2024/5/28 TI - Effects of a Chatbot-Based Intervention on Stress and Health-Related Parameters in a Stressed Sample: Randomized Controlled Trial JO - JMIR Ment Health SP - e50454 VL - 11 KW - chatbot KW - intervention KW - stress KW - interoception KW - interoceptive sensibility KW - mindfulness KW - emotion regulation KW - RCT KW - randomized controlled trial N2 - Background: Stress levels and the prevalence of mental disorders in the general population have been rising in recent years. Chatbot-based interventions represent novel and promising digital approaches to improve health-related parameters. However, there is a lack of research on chatbot-based interventions in the area of mental health. Objective: The aim of this study was to investigate the effects of a 3-week chatbot-based intervention guided by the chatbot ELME, specifically with respect to the ability to reduce stress and improve various health-related parameters in a stressed sample. Methods: In this multicenter two-armed randomized controlled trial, 118 individuals with medium to high stress levels were randomized to the intervention group (n=59) or the treatment-as-usual control group (n=59). The ELME chatbot guided participants of the intervention group through 3 weeks of training based on the topics stress, mindfulness, and interoception, with practical and psychoeducative elements delivered in two daily interactive intervention sessions via a smartphone (approximately 10-20 minutes each). The primary outcome (perceived stress) and secondary outcomes (mindfulness; interoception or interoceptive sensibility; subjective well-being; and emotion regulation, including the subfacets reappraisal and suppression) were assessed preintervention (T1), post intervention (T2; after 3 weeks), and at follow-up (T3; after 6 weeks). During both conditions, participants also underwent ecological momentary assessments of stress and interoceptive sensibility. Results: There were no significant changes in perceived stress (?03=?.018, SE=.329; P=.96) and momentary stress. Mindfulness and the subfacet reappraisal significantly increased in the intervention group over time, whereas there was no change in the subfacet suppression. Well-being and momentary interoceptive sensibility increased in both groups over time. Conclusions: To gain insight into how the intervention can be improved to achieve its full potential for stress reduction, besides a longer intervention duration, specific sample subgroups should be considered. The chatbot-based intervention seems to have the potential to improve mindfulness and emotion regulation in a stressed sample. Future chatbot-based studies and interventions in health care should be designed based on the latest findings on the efficacy of rule-based and artificial intelligence?based chatbots. Trial Registration: German Clinical Trials Register DRKS00027560; https://drks.de/search/en/trial/DRKS00027560 International Registered Report Identifier (IRRID): RR2-doi.org/10.3389/fdgth.2023.1046202 UR - https://mental.jmir.org/2024/1/e50454 UR - http://dx.doi.org/10.2196/50454 UR - http://www.ncbi.nlm.nih.gov/pubmed/38805259 ID - info:doi/10.2196/50454 ER - TY - JOUR AU - Zainal, Hani Nur AU - Newman, G. Michelle PY - 2024/5/24 TI - Examining the Effects of a Brief, Fully Self-Guided Mindfulness Ecological Momentary Intervention on Empathy and Theory-of-Mind for Generalized Anxiety Disorder: Randomized Controlled Trial JO - JMIR Ment Health SP - e54412 VL - 11 KW - empathy KW - theory-of-mind KW - mindfulness KW - ecological momentary intervention KW - generalized anxiety disorder KW - randomized controlled trial KW - mobile phone N2 - Background: The utility of brief mindfulness ecological momentary interventions (EMIs) to improve empathy and theory-of-mind has been underinvestigated, particularly in generalized anxiety disorder (GAD). Objective: In this randomized controlled trial, we aimed to examine the efficacy of a 14-day, fully self-guided, mindfulness EMI on the empathy and theory-of-mind domains for GAD. Methods: Adults (aged ?18 y) diagnosed with GAD were randomized to a mindfulness EMI (68/110, 61.8%) or self-monitoring app (42/110, 38.2%) arm. They completed the Interpersonal Reactivity Index self-report empathy measure and theory-of-mind test (Bell-Lysaker Emotion Recognition Task) at prerandomization, postintervention, and 1-month follow-up (1MFU) time points. Hierarchical linear modeling was conducted with the intent-to-treat principle to determine prerandomization to postintervention (pre-post intervention) and prerandomization to 1MFU (pre-1MFU) changes, comparing the mindfulness EMI to self-monitoring. Results: Observed effects were generally stronger from pre-1MFU than from pre-post intervention time points. From pre-post intervention time points, the mindfulness EMI was more efficacious than the self-monitoring app on fantasy (the ability to imagine being in others? shoes; between-intervention effect size: Cohen d=0.26, P=.007; within-intervention effect size: Cohen d=0.22, P=.02 for the mindfulness EMI and Cohen d=?0.16, P=.10 for the self-monitoring app). From pre-1MFU time points, the mindfulness EMI, but not the self-monitoring app, improved theory-of-mind (a window into others? thoughts and intentions through abstract, propositional knowledge about their mental states, encompassing the ability to decipher social cues) and the fantasy, personal distress (stress when witnessing others? negative experiences), and perspective-taking (understanding others? perspective) empathy domains. The effect sizes were small to moderate (Cohen d=0.15-0.36; P<.001 to P=.01) for significant between-intervention effects from pre-1MFU time points. Furthermore, the within-intervention effect sizes for these significant outcomes were stronger for the mindfulness EMI (Cohen d=0.30-0.43; P<.001 to P=.03) than the self-monitoring app (Cohen d=?0.12 to 0.21; P=.001 to P>.99) from pre-1MFU time points. No between-intervention and within-intervention effects on empathic concern (feeling affection, compassion, and care when observing others in distress, primarily attending to their emotional well-being) were observed from pre-post intervention and pre-1MFU time points. Conclusions: The brief mindfulness EMI improved specific domains of empathy (eg, fantasy, personal distress, and perspective-taking) and theory-of-mind with small to moderate effect sizes in persons with GAD. Higher-intensity, self-guided or coach-facilitated, multicomponent mindfulness EMIs targeting the optimization of social relationships are likely necessary to improve the empathic concern domain in this population. Trial Registration: ClinicalTrials.gov NCT04846777; https://clinicaltrials.gov/study/NCT04846777 UR - https://mental.jmir.org/2024/1/e54412 UR - http://dx.doi.org/10.2196/54412 UR - http://www.ncbi.nlm.nih.gov/pubmed/38787613 ID - info:doi/10.2196/54412 ER - TY - JOUR AU - Zainal, Hani Nur AU - Tan, Han Hui AU - Hong, Shiun Ryan Yee AU - Newman, Gayle Michelle PY - 2024/4/19 TI - Testing the Efficacy of a Brief, Self-Guided Mindfulness Ecological Momentary Intervention on Emotion Regulation and Self-Compassion in Social Anxiety Disorder: Randomized Controlled Trial JO - JMIR Ment Health SP - e53712 VL - 11 KW - social anxiety disorder KW - mindfulness KW - ecological momentary intervention KW - randomized controlled trial KW - emotion regulation KW - self-compassion KW - mechanisms of change KW - mobile phone KW - momentary interventions KW - self-monitoring app KW - regulations KW - participant N2 - Background: Theories propose that brief, mobile, self-guided mindfulness ecological momentary interventions (MEMIs) could enhance emotion regulation (ER) and self-compassion. Such changes are posited to be mechanisms of change. However, rigorous tests of these theories have not been conducted. Objective: In this assessor-blinded, parallel-group randomized controlled trial, we aimed to test these theories in social anxiety disorder (SAD). Methods: Participants with SAD (defined as having a prerandomization cut-off score ?20 on the Social Phobia Inventory self-report) were randomized to a 14-day fully self-guided MEMI (96/191, 50.3%) or self-monitoring app (95/191, 49.7%) arm. They completed web-based self-reports of 6 clinical outcome measures at prerandomization, 15-day postintervention (administered the day after the intervention ended), and 1-month follow-up time points. ER and self-compassion were assessed at preintervention and 7-day midintervention time points. Multilevel modeling determined the efficacy of MEMI on ER and self-compassion domains from pretrial to midintervention time points. Bootstrapped parallel multilevel mediation analysis examined the mediating role of pretrial to midintervention ER and self-compassion domains on the efficacy of MEMI on 6 clinical outcomes. Results: Participants demonstrated strong compliance, with 78% (149/191) engaging in at least 80% of the MEMI and self-monitoring prompts. MEMI was more efficacious than the self-monitoring app in decreasing ER goal?directed behavior difficulties (between-group Cohen d=?0.24) and lack of emotional clarity (Cohen d=0.16) and increasing self-compassion social connectedness (Cohen d=0.19), nonidentification with emotions (Cohen d=0.16), and self-kindness (Cohen d=0.19) from pretrial to midintervention time points. The within-group effect sizes from pretrial to midintervention were larger in the MEMI arm than in the self-monitoring app arm (ER goal?directed behavior difficulties: Cohen d=?0.73 vs ?0.29, lack of emotional clarity: Cohen d=?0.39 vs ?0.21, self-compassion domains of social connectedness: Cohen d=0.45 vs 0.19, nonidentification with emotions: Cohen d=0.63 vs 0.48, and self-kindness: Cohen d=0.36 vs 0.10). Self-monitoring, but not MEMI, alleviated ER emotional awareness issues (between-group Cohen d=0.11 and within-group: Cohen d=?0.29 vs ?0.13) and reduced self-compassion acknowledging shared human struggles (between-group Cohen d=0.26 and within-group: Cohen d=?0.23 vs 0.13). No ER and self-compassion domains were mediators of the effect of MEMI on SAD symptoms (P=.07-<.99), generalized anxiety symptoms (P=.16-.98), depression severity (P=.20-.94), repetitive negative thinking (P=.12-.96), and trait mindfulness (P=.18-.99) from pretrial to postintervention time points. Similar nonsignificant mediation effects emerged for all of these clinical outcomes from pretrial to 1-month follow-up time points (P=.11-.98). Conclusions: Brief, fully self-guided, mobile MEMIs efficaciously increased specific self-compassion domains and decreased ER difficulties associated with goal pursuit and clarity of emotions from pretrial to midintervention time points. Higher-intensity MEMIs may be required to pinpoint the specific change mechanisms in ER and self-compassion domains of SAD. Trial Registration: Open Science Framework (OSF) Registries; osf.io/m3kxz https://osf.io/m3kxz UR - https://mental.jmir.org/2024/1/e53712 UR - http://dx.doi.org/10.2196/53712 UR - http://www.ncbi.nlm.nih.gov/pubmed/38640015 ID - info:doi/10.2196/53712 ER - TY - JOUR AU - Gagnon, M. Michelle AU - Brilz, R. Alexandra AU - Alberts, M. Nicole AU - Gordon, L. Jennifer AU - Risling, L. Tracie AU - Stinson, N. Jennifer PY - 2024/4/8 TI - Understanding Adolescents? Experiences With Menstrual Pain to Inform the User-Centered Design of a Mindfulness-Based App: Mixed Methods Investigation Study JO - JMIR Pediatr Parent SP - e54658 VL - 7 KW - adolescent health KW - endometriosis KW - pain management, biopsychosocial KW - women?s health KW - dysmenorrhea KW - thematic analysis KW - mHealth KW - mobile health KW - app KW - apps KW - applications KW - attitude KW - attitudes KW - opinion KW - perception KW - perceptions KW - perspective KW - perspectives KW - interest KW - intent KW - intention KW - survey KW - surveys KW - focus group KW - focus groups KW - content analysis KW - mindfulness KW - meditation KW - menstrual KW - menstruation KW - experience KW - experiences KW - pain KW - youth KW - adolescent KW - adolescents KW - teen KW - teens KW - teenager KW - teenagers N2 - Background: Digital interventions are increasingly popular for the provision of nonpharmacological pain interventions, but few exist for adolescents with menstrual pain. User-centered design involves incorporating users across phases of digital health intervention design, development, and implementation and leads to improved user engagement and outcomes. A needs assessment is the first step of this approach. Objective: The goal of this study was to conduct a needs assessment to understand menstrual pain management needs and preferences and mindfulness experiences, preferences, and knowledge of adolescents with menstrual pain to inform the future development of an app for managing menstrual pain. Methods: We used an explanatory sequential mixed method design that included a survey followed by focus groups. Adolescents aged 13-17 years completed a survey (n=111) and participated in focus groups (n=16). Data were analyzed using descriptive statistics and thematic content analysis and synthesized to provide specific recommendations based on adolescent responses. Results: Adolescents (n=111) who completed the survey reported a moderate understanding of mindfulness and menstrual pain. Over three-quarters (n=87, 78%) of participants practiced some form of mindfulness and 87% (n=97) of survey participants used nonpharmacological pain management strategies. Teens had a moderate perception that mindfulness could help their menstrual pain (mean 4.51/10, SD 2.45, with higher scores suggesting more interest). Themes were generated related to mindfulness experiences, menstrual pain knowledge and experiences, and app functionality. These themes underscored adolescents? need for continued support and flexible access to mindfulness activities; their awareness of multiple influences to pain, with potential for further education in this area; and the need for menstrual pain?specific content, along with content relevant to typical day-to-day experiences of adolescents. Conclusions: Adolescents with menstrual pain have an interest in using a mindfulness app for pain but have unique needs that need to be addressed to ensure app engagement and relevance for this population. Concrete recommendations for future app development are provided. UR - https://pediatrics.jmir.org/2024/1/e54658 UR - http://dx.doi.org/10.2196/54658 UR - http://www.ncbi.nlm.nih.gov/pubmed/38587886 ID - info:doi/10.2196/54658 ER - TY - JOUR AU - Stefana, Alberto AU - Vieta, Eduard AU - Fusar-Poli, Paolo AU - Youngstrom, A. Eric PY - 2024/4/8 TI - Enhancing Psychotherapy Outcomes by Encouraging Patients to Regularly Self-Monitor, Reflect on, and Share Their Affective Responses Toward Their Therapist: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e55369 VL - 13 KW - adult patients KW - evidence-based assessment KW - patient?s perspective KW - psychotherapy KW - randomized controlled trial KW - systematic client feedback KW - therapeutic relationship KW - treatment outcome N2 - Background: The quality of the therapeutic relationship is pivotal in determining psychotherapy outcomes. However, facilitating patients? self-awareness, reflection on, and sharing of their affective responses toward their therapist remains underexplored as a potential tool for enhancing this relationship and subsequent treatment outcomes. Objective: The primary objective of this study is to examine whether and how the patients? regular self-monitoring and self-reflection (fostered by the systematic compilation of a brief postsession battery) on their affective reactions toward the psychotherapist impact the quality of the therapeutic relationship and treatment outcomes in individual psychotherapy. Secondary objectives are to (1) explore whether and how the characteristics of the patient, the therapist, and the process moderate the effect of regular self-monitoring on the therapeutic relationship and outcomes; (2) examine the relationships between the affective response of the patient, the alliance, and the result of the therapy session outcome; and (3) explore how the affective responses of the patient unfold or change throughout the course of the therapy. Methods: We conducted a 1:1 randomized controlled trial of adults in individual psychotherapy versus individual psychotherapy plus self-monitoring. Participants will be enrolled through the web-based recruitment platforms ?ResearchMatch? and ?Research for Me,? and data will be collected through web-based surveys. Participants in the control group will receive only their regular individual psychotherapy (treatment as usual) and will not complete postsession questionnaires. Participants in the intervention group will continue their regular individual psychotherapy sessions and complete the ?in-Session Patient Affective Reactions Questionnaire? and the ?Rift In-Session Questionnaire? following each therapy session in the 10 weeks of the trial. Additionally, after completion of the postsession battery, they will receive general written feedback encouraging them to discuss their feelings and reflections with their therapist. Participants in both groups will complete a comprehensive psychological assessment at baseline, midtrial (week 5), and end-of-trial (week 10). The primary outcome measure of the trial is the ?Clinical Outcomes in Routine Evaluation-Outcome Measure,? while the secondary outcomes are the ?Real Relationship Inventory-Client-Short Form,? the ?Working Alliance Inventory-Short Revised,? and the number of scheduled therapy sessions that the patient has missed or canceled. Results: The trial was approved by the institutional review board of the University of North Carolina at Chapel Hill. Recruitment started in September 2023. A total of 475 individuals completed the baseline assessment. Data collection was completed in February 2024. The results are expected to be published in the autumn of 2024. Conclusions: This study could reveal key information on how regular self-monitoring and introspection can influence both the therapeutic relationship and treatment outcomes. Findings have the potential to shape interventions, enhance the efficacy of psychotherapeutic sessions, and possibly offer a cost-effective strategy for improving patients? well-being. Trial Registration: ClinicalTrials.gov NCT06038747; https://classic.clinicaltrials.gov/ct2/show/NCT06038747 International Registered Report Identifier (IRRID): DERR1-10.2196/55369 UR - https://www.researchprotocols.org/2024/1/e55369 UR - http://dx.doi.org/10.2196/55369 UR - http://www.ncbi.nlm.nih.gov/pubmed/38587881 ID - info:doi/10.2196/55369 ER - TY - JOUR AU - O'Kane, K. Kiarah M. AU - Otamendi, Thalia AU - Silverberg, D. Noah AU - Choi, Esther AU - Sicard, Veronik AU - Zemek, Roger AU - Healey, Katherine AU - Brown, Olivier AU - Butterfield, Lauren AU - Smith, Andra AU - Goldfield, Gary AU - Kardish, Rachel AU - Saab, J. Bechara AU - Ledoux, Andrée-Anne AU - Cairncross, Molly PY - 2024/3/22 TI - Development of Therapeutic Alliance and Social Presence in a Digital Intervention for Pediatric Concussion: Qualitative Exploratory Study JO - JMIR Form Res SP - e49133 VL - 8 KW - adolescent KW - concussion KW - digital therapeutics KW - eHealth KW - mHealth KW - mindfulness KW - mobile health KW - social presence KW - working alliance N2 - Background: Despite the promising benefits of self-guided digital interventions for adolescents recovering from concussion, attrition rates for such interventions are high. Evidence suggests that adults can develop therapeutic alliance with self-guided digital interventions, which is in turn associated with intervention engagement. However, no research has examined whether adolescents develop therapeutic alliance with self-guided digital interventions and what factors are important to its development. Additionally, social presence?the extent to which digital encounters feel like they are occurring in person?may be another relevant factor to understanding the nature of the connection between adolescents and a self-guided digital intervention, though this has yet to be explored. Objective: This qualitative study explored the extent to which adolescents recovering from concussion developed therapeutic alliance and social presence during their use of a self-guided digital mindfulness-based intervention. Additionally, this study aimed to determine factors important to adolescents? development of therapeutic alliance and social presence with the intervention. Methods: Adolescents aged between 12 and 17.99 years who sustained a concussion were recruited from 2 sites: a pediatric emergency department up to 48 hours after a concussion and a tertiary care clinic over 1 month following a concussion to capture adolescents who had both acute and persisting symptoms after concussion. Participants (N=10) completed a 4-week mindfulness-based intervention delivered through a smartphone app. Within the app, participants listened to audio recordings of mindfulness guides (voice actors) narrating psychoeducation and mindfulness practices. At 4 weeks, participants completed questionnaires and a semistructured interview exploring their experience of therapeutic alliance and social presence with the mindfulness guides in the intervention. Results: Themes identified within the qualitative results revealed that participants developed therapeutic alliance and social presence by ?developing a genuine connection? with their mindfulness guides and ?sensing real people.? Particularly important to the development of therapeutic alliance and social presence were the mindfulness guides? ?personal backgrounds and voices,? such that participants felt more connected to the guides by knowing information about them and through the guides? calm tone of voice in audio recordings. Quantitative findings supported qualitative results; participants? average score for therapeutic alliance was far above the scale midpoint, while the mixed results for social presence measures aligned with qualitative findings that participants felt that the mindfulness guides seemed real but not quite as real as an in-person connection would. Conclusions: Our data suggest that adolescents can develop therapeutic alliance and social presence when using digital interventions with no direct human contact. Adolescents? development of therapeutic alliance and social presence with self-guided digital interventions can be bolstered by increasing human-like qualities (eg, real voices) within interventions. Maximizing therapeutic alliance and social presence may be a promising way to reduce attrition in self-guided digital interventions while providing accessible treatment. UR - https://formative.jmir.org/2024/1/e49133 UR - http://dx.doi.org/10.2196/49133 UR - http://www.ncbi.nlm.nih.gov/pubmed/38517472 ID - info:doi/10.2196/49133 ER - TY - JOUR AU - Elliott, Mary AU - Khallouf, Camille AU - Hirsch, Jennifer AU - de Camps Meschino, Diane AU - Zamir, Orit AU - Ravitz, Paula PY - 2024/3/14 TI - Novel Web-Based Drop-In Mindfulness Sessions (Pause-4-Providers) to Enhance Well-Being Among Health Care Workers During the COVID-19 Pandemic: Descriptive and Qualitative Study JO - JMIR Form Res SP - e43875 VL - 8 KW - COVID-19 KW - pandemic KW - health care worker KW - resilience KW - mental health KW - burnout KW - well-being KW - mindfulness meditation KW - web-based group KW - drop-in KW - mindfulness KW - health care staff KW - meditation KW - worker KW - job KW - occupational health N2 - Background: The COVID-19 pandemic exerted extraordinary pressure on health care workers (HCWs), imperiling their well-being and mental health. In response to the urgent demand to provide barrier-free support for the health care workforce, Pause-4-Providers implemented 30-minute live web-based drop-in mindfulness sessions for HCWs. Objective: This study aims to evaluate the use, feasibility, satisfaction, and acceptability of a novel mindfulness program aimed at enhancing the well-being of HCWs during the COVID-19 pandemic. Methods: Accrual for the study continued throughout the first 3 pandemic waves, and attendees of ?1 session were invited to participate. The evaluation framework included descriptive characteristics, including participant demographics, resilience at work, and single-item burnout scores; feedback questionnaires on reasons attended, benefits, and satisfaction; qualitative interviews to further understand participant experience, satisfaction, benefits, enablers, and barriers; and the number of participants in each session summarized according to the pandemic wave. Results: We collected descriptive statistics from 50 consenting HCWs. Approximately half of the participants (24/50, 48%) attended >1 session. The study participants were predominantly female individuals (40/50, 80%) and comprised physicians (17/50, 34%), nurses (9/50, 18%), and other HCWs (24/50, 48%), who were largely from Ontario (41/50, 82%). Of 50 attendees, 26 (52%) endorsed feeling burned out. The highest attendance was in May 2020 and January 2021, corresponding to the first and second pandemic waves. The participants endorsed high levels of satisfaction (43/47, 92%). The most cited reasons for attending the program were to relax (38/48, 79%), manage stress or anxiety (36/48, 75%), wish for loving kindness or self-compassion (30/48, 64%), learn mindfulness (30/48, 64%), and seek help with emotional reactivity (25/48, 53%). Qualitative interviews with 15 out of 50 (30%) participants identified positive personal and professional impacts. Personal impacts revealed that participation helped HCWs to relax, manage stress, care for themselves, sleep better, reduce isolation, and feel recognized. Professional impacts included having a toolbox of mindfulness techniques, using mindfulness moments, and being calmer at work. Some participants noted that they shared techniques with their colleagues. The reported barriers included participants? needing time to prioritize themselves, fatigue, forgetting to apply skills on the job, and finding a private place to participate. Conclusions: The Pause-4-Providers participants reported that the web-based groups were accessible; appreciated the format, content, and faculty; and had high levels of satisfaction with the program. Both novel format (eg, drop-in, live, web-based, anonymous, brief, and shared activity with other HCWs) and content (eg, themed mindfulness practices including micropractices, with workplace applications) were enablers to participation. This study of HCW support sessions was limited by the low number of consenting participants and the rolling enrollment project design; however, the findings suggest that a drop-in web-based mindfulness program has the potential to support the well-being of HCWs. UR - https://formative.jmir.org/2024/1/e43875 UR - http://dx.doi.org/10.2196/43875 UR - http://www.ncbi.nlm.nih.gov/pubmed/38180869 ID - info:doi/10.2196/43875 ER - TY - JOUR AU - Gao, Yu AU - Shi, Lu AU - Fu, Ning AU - Yang, Nan AU - Weeks-Gariepy, Tracy AU - Mao, Yuping PY - 2024/3/8 TI - Mobile-Delivered Mindfulness Intervention on Anxiety Level Among College Athletes: Randomized Controlled Trial JO - J Med Internet Res SP - e40406 VL - 26 KW - anxiety KW - athletes KW - body KW - calmness KW - cognition KW - college students KW - college KW - feasibility KW - feedback KW - intervention KW - meditation KW - mHealth KW - mindfulness KW - mobile KW - participant KW - positive KW - program KW - relaxation KW - sleep KW - students N2 - Background: College athletes are a group often affected by anxiety. Few interventional studies have been conducted to address the anxiety issues in this population. Objective: We conducted a mobile-delivered mindfulness intervention among college athletes to study its feasibility and efficacy in lowering their anxiety level and improving their mindfulness (measured by the Five Facet Mindfulness Questionnaire [FFMQ]). Methods: In April 2019, we recruited 290 college athletes from a public university in Shanghai, China, and 288 of them were randomized into an intervention group and a control group (closed trial), with the former (n=150) receiving a therapist-guided, smartphone-delivered mindfulness-based intervention and the latter receiving mental health promotion messages (n=138). We offered in-person instructions during the orientation session for the intervention group in a classroom, with the therapist interacting with the participants on the smartphone platform later during the intervention. We used generalized linear modeling and the intent-to-treat approach to compare the 2 groups' outcomes in dispositional anxiety, precompetition anxiety, and anxiety during competition, plus the 5 dimensions of mindfulness (measured by the FFMQ). Results: Our intent-to-treat analysis and generalized linear modeling found no significant difference in dispositional anxiety, precompetition anxiety, or anxiety during competition. Only the ?observation? facet of mindfulness measures had a notable difference between the changes experienced by the 2 groups, whereby the intervention group had a net gain of .214 yet fell short of reaching statistical significance (P=.09). Participants who specialized in group sports had a higher level of anxiety (?=.19; SE=.08), a lower level of ?nonjudgemental inner experience? in FFMQ (?=?.07; SE=.03), and a lower level of ?nonreactivity? (?=?.138; SE=.052) than those specializing in individual sports. Conclusions: No significant reduction in anxiety was detected in this study. Based on the participant feedback, the time availability for mindfulness practice and session attendance for these student athletes in an elite college could have compromised the intervention?s effectiveness. Future interventions among this population could explore a more student-friendly time schedule (eg, avoid final exam time) or attempt to improve cognitive and scholastic outcomes. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024449; https://www.chictr.org.cn/showproj.html?proj=40865 UR - https://www.jmir.org/2024/1/e40406 UR - http://dx.doi.org/10.2196/40406 UR - http://www.ncbi.nlm.nih.gov/pubmed/38457201 ID - info:doi/10.2196/40406 ER - TY - JOUR AU - Jones, Grant AU - Herrmann, Felipe AU - Bear, Adam AU - Carhart-Harris, Robin AU - Kettner, Hannes PY - 2024/3/4 TI - The Relationship Between Changes in Mindfulness and Subsequent Changes in Well-Being Following Psychedelic Use: Prospective Cohort Study JO - JMIR Form Res SP - e54632 VL - 8 KW - psychedelics KW - mindfulness KW - observational KW - web-based survey KW - psychedelic KW - meditation KW - mental health KW - anxiety KW - depression KW - survey KW - surveys KW - drug KW - drugs KW - substance use KW - hallucinogen KW - hallucinogens UR - https://formative.jmir.org/2024/1/e54632 UR - http://dx.doi.org/10.2196/54632 UR - http://www.ncbi.nlm.nih.gov/pubmed/38437005 ID - info:doi/10.2196/54632 ER - TY - JOUR AU - Badaghi, Nasim AU - van Kruijsbergen, Mette AU - Speckens, Anne AU - Vilé, Joëlle AU - Prins, Judith AU - Kelders, Saskia AU - Kwakkenbos, Linda PY - 2024/2/21 TI - Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial JO - JMIR Form Res SP - e52338 VL - 8 KW - cancer KW - eHeath KW - online interventions KW - mindfulness KW - psycho-oncology KW - qualitative research KW - oncology KW - CBT KW - blended KW - eMBCT KW - iCBT KW - cognitive therapy KW - unguided KW - psychotherapy KW - MBCT KW - co-creation KW - therapist KW - self-guided KW - peer-support KW - co-design KW - participatory N2 - Background: Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. Objective: The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. Methods: Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. Results: We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). Conclusions: Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. Trial Registration: ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916 UR - https://formative.jmir.org/2024/1/e52338 UR - http://dx.doi.org/10.2196/52338 UR - http://www.ncbi.nlm.nih.gov/pubmed/38381493 ID - info:doi/10.2196/52338 ER - TY - JOUR AU - Zou, Huijing AU - Chair, Ying Sek AU - Feng, Bilong AU - Liu, Qian AU - Liu, Jia Yu AU - Cheng, Xin Yu AU - Luo, Dan AU - Wang, Qin Xiao AU - Chen, Wei AU - Huang, Leiqing AU - Xianyu, Yunyan AU - Yang, Xiang Bing PY - 2024/2/20 TI - A Social Media?Based Mindfulness Psycho-Behavioral Intervention (MCARE) for Patients With Acute Coronary Syndrome: Randomized Controlled Trial JO - J Med Internet Res SP - e48557 VL - 26 KW - acute coronary syndrome KW - psychological distress KW - depression KW - anxiety KW - mindfulness KW - mindfulness-based intervention KW - quality of life KW - risk factors KW - cardiac rehabilitation KW - social media N2 - Background: Psychological distress is common among patients with acute coronary syndrome (ACS) and has considerable adverse impacts on disease progression and health outcomes. Mindfulness-based intervention is a promising complementary approach to address patients? psychological needs and promote holistic well-being. Objective: This study aims to examine the effects of a social media?based mindfulness psycho-behavioral intervention (MCARE) on psychological distress, psychological stress, health-related quality of life (HRQoL), and cardiovascular risk factors among patients with ACS. Methods: This study was a 2-arm, parallel-group randomized controlled trial. We recruited 178 patients (mean age 58.7, SD 8.9 years; 122/178, 68.5% male) with ACS at 2 tertiary hospitals in Jinan, China. Participants were randomly assigned to the MCARE group (n=89) or control group (n=89). The 6-week intervention consisted of 1 face-to-face session (phase I) and 5 weekly WeChat (Tencent Holdings Ltd)?delivered sessions (phase II) on mindfulness training and health education and lifestyle modification. The primary outcomes were depression and anxiety. Secondary outcomes included psychological stress, HRQoL, and cardiovascular risk factors (ie, smoking status, physical activity, dietary behavior, BMI, blood pressure, blood lipids, and blood glucose). Outcomes were measured at baseline (T0), immediately after the intervention (T1), and 12 weeks after the commencement of the intervention (T2). Results: The MCARE group showed significantly greater reductions in depression (T1: ?=?2.016, 95% CI ?2.584 to ?1.449, Cohen d=?1.28, P<.001; T2: ?=?2.089, 95% CI ?2.777 to ?1.402, Cohen d=?1.12, P<.001) and anxiety (T1: ?=?1.024, 95% CI ?1.551 to ?0.497, Cohen d=?0.83, P<.001; T2: ?=?0.932, 95% CI ?1.519 to ?0.346, Cohen d=?0.70, P=.002). Significantly greater improvements were also observed in psychological stress (?=?1.186, 95% CI ?1.678 to ?0.694, Cohen d=?1.41, P<.001), physical HRQoL (?=0.088, 95% CI 0.008-0.167, Cohen d=0.72, P=.03), emotional HRQoL (?=0.294, 95% CI 0.169-0.419, Cohen d=0.81, P<.001), and general HRQoL (?=0.147, 95% CI 0.070-0.224, Cohen d=1.07) at T1, as well as dietary behavior (?=0.069, 95% CI 0.003-0.136, Cohen d=0.75, P=.04), physical activity level (?=177.542, 95% CI ?39.073 to 316.011, Cohen d=0.51, P=.01), and systolic blood pressure (?=?3.326, 95% CI ?5.928 to ?0.725, Cohen d=?1.32, P=.01) at T2. The overall completion rate of the intervention (completing ?5 sessions) was 76% (68/89). Positive responses to the questions of the acceptability questionnaire ranged from 93% (76/82) to 100% (82/82). Conclusions: The MCARE program generated favorable effects on psychological distress, psychological stress, HRQoL, and several aspects of cardiovascular risk factors in patients with ACS. This study provides clues for guiding clinical practice in the recognition and management of psychological distress and integrating the intervention into routine rehabilitation practice. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000033526; https://www.chictr.org.cn/showprojEN.html?proj=54693 UR - https://www.jmir.org/2024/1/e48557 UR - http://dx.doi.org/10.2196/48557 UR - http://www.ncbi.nlm.nih.gov/pubmed/38376899 ID - info:doi/10.2196/48557 ER - TY - JOUR AU - Peterson, E. Neil AU - Thomas, Michael AU - Hunsaker, Stacie AU - Stewart, Tevin AU - Collett, J. Claire PY - 2024/2/16 TI - mHealth Gratitude Exercise Mindfulness App for Resiliency Among Neonatal Intensive Care Unit Staff: Three-Arm Pretest-Posttest Interventional Study JO - JMIR Nursing SP - e54561 VL - 7 KW - burnout KW - compassion fatigue KW - compassion satisfaction KW - secondary trauma KW - trauma KW - satisfaction KW - compassion KW - gratitude KW - resilience KW - quality of life KW - QoL KW - mindfulness KW - meditation KW - exercise KW - happiness KW - mHealth KW - mobile health KW - app KW - apps KW - applications KW - neonatal intensive care unit KW - NICU KW - intensive care unit KW - ICU KW - intensive care KW - nurse KW - nurses KW - nursing KW - health care worker KW - health care workers KW - provider KW - providers KW - phone app KW - physical activity KW - resiliency KW - mobile phone N2 - Background: Health care is highly complex and can be both emotionally and physically challenging. This can lead health care workers to develop compassion fatigue and burnout (BO), which can negatively affect their well-being and patient care. Higher levels of resilience can potentially prevent compassion fatigue and BO. Strategies that enhance resilience include gratitude, exercise, and mindfulness. Objective: The purpose of this study was to determine if a 3-week daily resiliency practice, prompted via a gratitude, exercise, and mindfulness smartphone app, impacted the professional quality of life, physical activity, and happiness level of health care workers in a newborn intensive care unit setting. Methods: In total, 65 participants from a level III newborn intensive care unit at a regional hospital in the western United States completed this study. The Professional Quality of Life Scale, Physical Activity Vital Sign, and Subjective Happiness Score instruments were used to evaluate the effects of the mobile health (mHealth) intervention. Further, 2-tailed dependent paired t tests were used to evaluate participant pre- and postintervention instrument scores. Multiple imputation was used to predict scores of participants who practiced an intervention but did not complete the 3 instruments post intervention. Results: Dependent t tests using the original data showed that participants, as a whole, significantly improved in BO (t35=2.30, P=.03), secondary trauma stress (STS; t35=2.11, P=.04), and happiness (t35=?3.72, P<.001) scores. Compassion satisfaction (CS; t35=?1.94, P=.06) and exercise (t35=?1.71, P=.10) were trending toward, but did not reach, significance. Using the original data, only the gratitude intervention group experienced significant improvements (CS, BO, and happiness), likely due to the higher number of participants in this group. Analysis using imputed data showed that participants, as a whole, had significant improvements in all areas: CS (t64=?4.08, P<.001), BO (t64=3.39, P=.001), STS (t64=4.08, P<.001), exercise (t64=?3.19, P=.002), and happiness (t64=?3.99, P<.001). Looking at the intervention groups separately using imputed data, the gratitude group had significant improvements in CS, BO, STS, and happiness; the exercise group had significant improvements in STS and exercise; and the mindfulness group had significant improvements in CS and happiness. Conclusions: Phone app delivery of resilience-enhancing interventions is a potentially effective intervention model for health care workers. Potential barriers to mHealth strategies are the technical issues that can occur with this type of intervention. Additional longitudinal and experimental studies with larger sample sizes need to be completed to better evaluate this modality. UR - https://nursing.jmir.org/2024/1/e54561 UR - http://dx.doi.org/10.2196/54561 UR - http://www.ncbi.nlm.nih.gov/pubmed/38363595 ID - info:doi/10.2196/54561 ER - TY - JOUR AU - Orasud, Siritorn Ariel AU - Uchiyama, Mai AU - Pagano, Ian AU - Bantum, Erin PY - 2024/2/12 TI - Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e47745 VL - 13 KW - cancer KW - cancer survivorship KW - mindfulness meditation KW - mHealth KW - well-being KW - quality of life KW - mobile health KW - coaching KW - coach KW - mindfulness KW - meditation KW - survivor KW - survivorship KW - oncology KW - mental health KW - anxiety KW - neuropathy KW - survivors KW - RCT KW - randomized KW - clinical trial KW - clinical trials N2 - Background: Anxiety- and cancer-related neuropathy are two persistent effects related to treatment for cancer. Mindfulness meditation has been used with substantial impact as a nonpharmacologic intervention to mitigate side and late effects of treatment. Mobile apps are ubiquitous for most of the general population, yet have a particular relevance for cancer survivors, given that physical and geographic limitations can be present. Objective: This study aims to describe an ongoing trial of the Mindfulness Coach mobile app for cancer survivors. Methods: In this randomized waitlist controlled trial, cancer survivors experiencing anxiety- or cancer-related neuropathy (200 for neuropathy and 200 for anxiety) and who had finished primary cancer treatment were invited to participate. Data were collected at 3 time points regardless of randomization condition: baseline, 8 weeks, and 16 weeks. Both face-to-face and web-based recruitment strategies were used. The trial was opened for 2 separate primary outcomes (anxiety- or cancer-related neuropathy). The goal was not to compare these groups but to compare treatment and waitlist groups for each condition. In addition to evaluating the impact of mobile mindfulness on reported anxiety- or cancer-related neuropathy, other pain, fatigue, trauma, sleep, and satisfaction with the Mindfulness Coach app will also be assessed. Results: Outcomes of the study are expected in early 2024. Conclusions: Mindfulness meditation has become widely practiced, and the use of mobile technology has become ubiquitous. Finding ways to deliver mindfulness meditation to people who have been treated for cancer allows for the intervention to be accessible to a larger number of survivors. The results of this intervention could have implications for further understanding the impact of mindfulness meditation on 2 persistent side and late effects of treatment of cancer, namely anxiety- and cancer-related neuropathy. Trial Registration: ClinicalTrials.gov NCT03581357; https://ClinicalTrials.gov/study/NCT03581357 International Registered Report Identifier (IRRID): DERR1-10.2196/47745 UR - https://www.researchprotocols.org/2024/1/e47745 UR - http://dx.doi.org/10.2196/47745 UR - http://www.ncbi.nlm.nih.gov/pubmed/38345843 ID - info:doi/10.2196/47745 ER - TY - JOUR AU - Jaiswal, Satish AU - Purpura, R. Suzanna AU - Manchanda, K. James AU - Nan, Jason AU - Azeez, Nihal AU - Ramanathan, Dhakshin AU - Mishra, Jyoti PY - 2024/1/22 TI - Design and Implementation of a Brief Digital Mindfulness and Compassion Training App for Health Care Professionals: Cluster Randomized Controlled Trial JO - JMIR Ment Health SP - e49467 VL - 11 KW - compassion KW - digital app KW - digital health KW - digital intervention KW - digital mental health KW - digital mindfulness KW - EEG KW - health workers KW - healthcare professionals KW - mindfulness KW - neuroplasticity KW - physicians KW - training N2 - Background: Several studies show that intense work schedules make health care professionals particularly vulnerable to emotional exhaustion and burnout. Objective: In this scenario, promoting self-compassion and mindfulness may be beneficial for well-being. Notably, scalable, digital app?based methods may have the potential to enhance self-compassion and mindfulness in health care professionals. Methods: In this study, we designed and implemented a scalable, digital app?based, brief mindfulness and compassion training program called ?WellMind? for health care professionals. A total of 22 adult participants completed up to 60 sessions of WellMind training, 5-10 minutes in duration each, over 3 months. Participants completed behavioral assessments measuring self-compassion and mindfulness at baseline (preintervention), 3 months (postintervention), and 6 months (follow-up). In order to control for practice effects on the repeat assessments and calculate effect sizes, we also studied a no-contact control group of 21 health care professionals who only completed the repeated assessments but were not provided any training. Additionally, we evaluated pre- and postintervention neural activity in core brain networks using electroencephalography source imaging as an objective neurophysiological training outcome. Results: Findings showed a post- versus preintervention increase in self-compassion (Cohen d=0.57; P=.007) and state-mindfulness (d=0.52; P=.02) only in the WellMind training group, with improvements in self-compassion sustained at follow-up (d=0.8; P=.01). Additionally, WellMind training durations correlated with the magnitude of improvement in self-compassion across human participants (?=0.52; P=.01). Training-related neurophysiological results revealed plasticity specific to the default mode network (DMN) that is implicated in mind-wandering and rumination, with DMN network suppression selectively observed at the postintervention time point in the WellMind group (d=?0.87; P=.03). We also found that improvement in self-compassion was directly related to the extent of DMN suppression (?=?0.368; P=.04). Conclusions: Overall, promising behavioral and neurophysiological findings from this first study demonstrate the benefits of brief digital mindfulness and compassion training for health care professionals and compel the scale-up of the digital intervention. Trial Registration: Trial Registration: International Standard Randomized Controlled Trial Number Registry ISRCTN94766568, https://www.isrctn.com/ISRCTN94766568 UR - https://mental.jmir.org/2024/1/e49467 UR - http://dx.doi.org/10.2196/49467 UR - http://www.ncbi.nlm.nih.gov/pubmed/38252479 ID - info:doi/10.2196/49467 ER - TY - JOUR AU - Dover, Saunya AU - Ahmet, Alexandra AU - Bluth, Karen AU - Feldman, M. Brian AU - Goldbloom, B. Ellen AU - Goldfield, S. Gary AU - Hamilton, Sarah AU - Imran, Omar AU - Khalif, Adam AU - Khatchadourian, Karine AU - Lawrence, Sarah AU - Leonard, Andrew AU - Liu, Kuan AU - Ouyang, Yongdong AU - Peeters, Corien AU - Shah, Jai AU - Spector, Noah AU - Zuijdwijk, Caroline AU - Robinson, Marie-Eve PY - 2023/12/26 TI - Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e53935 VL - 12 KW - anxiety KW - depression KW - diabetes distress KW - disordered eating KW - mental health KW - mindful self-compassion KW - pediatrics KW - randomized controlled trial KW - type 1 diabetes N2 - Background: Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one?s own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught and therefore represents an opportunity for intervention. Objective: The overall aim of this study is to assess the effectiveness of a web-based mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicidal ideation experienced by youth with T1D (aged between 12 and 17 years) compared with a waitlist control group (standard of care). We will also explore (1) if the effect of the MSC-T intervention changes over time, (2) if the MSC-T intervention has a positive impact on measures of glycemic control, and (3) if the effect of the MSC-T intervention differs based on self-reported gender. Methods: We will conduct a single-center, parallel-group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the waitlist control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes-Teen (PAID-T) version at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety Disorder 7-item [GAD-7] scale), depression (Patient Health Questionnaire-9 [PHQ-9]), diabetes-related disordered eating (Diabetes Eating Problem Survey-Revised [DEPS-R] version), and suicidal ideation (using 1 question from the PHQ-9). Results: Study recruitment began in October 2022 and was completed in March 2023, with a total of 141 participants enrolling. Data collection will be ongoing until March 2024. The first results are expected in June 2024. Conclusions: This study will be the first randomized trial to assess the effectiveness of the web-based MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount. Trial Registration: ClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874 International Registered Report Identifier (IRRID): DERR1-10.2196/53935 UR - https://www.researchprotocols.org/2023/1/e53935 UR - http://dx.doi.org/10.2196/53935 UR - http://www.ncbi.nlm.nih.gov/pubmed/38048480 ID - info:doi/10.2196/53935 ER - TY - JOUR AU - Balsam, Donna AU - Bounds, T. Dawn AU - Rahmani, M. Amir AU - Nyamathi, Adeline PY - 2023/12/25 TI - Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study JO - JMIR Pediatr Parent SP - e53933 VL - 6 KW - mindfulness app KW - pregnancy KW - pregnant KW - maternal KW - obstetric KW - obstetrics KW - stress KW - anxiety KW - heart rate variability KW - mindfulness KW - mHealth KW - mobile health KW - app KW - apps KW - applications KW - mental health KW - meditation KW - mind-body KW - complementary KW - alternative KW - heart rate KW - sleep KW - mobile phone N2 - Background: Stress and anxiety during pregnancy are extremely prevalent and are associated with numerous poor outcomes, among the most serious of which are increased rates of preterm birth and low birth weight infants. Research supports that while in-person mindfulness training is effective in reducing pregnancy stress and anxiety, there are barriers limiting accessibility. Objective: The aim of this paper is to determine if mindfulness meditation training with the Headspace app is effective for stress and anxiety reduction during pregnancy. Methods: A longitudinal, single-arm trial was implemented with 20 pregnant women who were instructed to practice meditation via the Headspace app twice per day during the month-long trial. Validated scales were used to measure participant?s levels of stress and anxiety pre- and postintervention. Physiological measures reflective of stress (heart rate variability and sleep) were collected via the Oura Ring. Results: Statistically significant reductions were found in self-reported levels of stress (P=.005), anxiety (P=.01), and pregnancy anxiety (P<.0001). Hierarchical linear modeling revealed a statistically significant reduction in the physiological data reflective of stress in 1 of 6 heart rate variability metrics, the low-frequency power band, which decreased by 13% (P=.006). A total of 65% of study participants (n=13) reported their sleep improved during the trial, and 95% (n=19) stated that learning mindfulness helped with other aspects of their lives. Participant retention was 100%, with 65% of participants (n=13) completing about two-thirds of the intervention, and 50% of participants (n=10) completing ?95%. Conclusions: This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy. UR - https://pediatrics.jmir.org/2023/1/e53933 UR - http://dx.doi.org/10.2196/53933 UR - http://www.ncbi.nlm.nih.gov/pubmed/38145479 ID - info:doi/10.2196/53933 ER - TY - JOUR AU - Presciutti, Mattia Alexander AU - Woodworth, Emily AU - Rochon, Elizabeth AU - Neale, Molly AU - Motta, Melissa AU - Piazza, Joseph AU - Vranceanu, Ana-Maria AU - Hwang, Yi-Gin David PY - 2023/10/25 TI - A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial JO - JMIR Res Protoc SP - e50860 VL - 12 KW - severe acute brain injury KW - coma KW - caregiver KW - resilience KW - mindfulness KW - brain injury KW - emotional distress KW - decision-making KW - emotional support KW - intervention KW - support KW - self-report assessment KW - mental health N2 - Background: Caregivers of patients with severe acute brain injuries (SABI) that lead to coma and require intensive care unit (ICU) treatment often experience chronic emotional distress. To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers. Objective: We will conduct an open pilot trial of COMA-F (National Institutes of Health Stage IA). Here we describe our study protocol and proposed intervention content. Methods: We will enroll 15 caregivers of patients with SABIs during their loved one?s hospital course from 3 enrollment centers. A clinical psychologist will deliver the COMA-F intervention (6 sessions) over Zoom (Zoom Video Communications, Inc) or in person. We will iterate COMA-F after each caregiver completes the intervention and an exit interview. English-speaking adults who have emotional distress confirmed by the clinical team and are the primary caregivers of a patient with SABI are eligible. The adult patient must have been admitted to the neuro-ICU for SABI and (1) have had a Glasgow Coma Scale score below 9 while not intubated or an inability to follow meaningful commands while intubated at any point during their hospitalization for >24 hours due to SABI; (2) will be undergoing either tracheostomy or percutaneous endoscopic or surgical gastrostomy tube placement or have already received one or both; and (3) have a prognosis of survival >3 months. We will identify eligible caregivers through screening patients? medical records and through direct referrals from clinicians in the neuro-ICU. During the intervention we will teach caregivers mind-body and resilience skills, including deep breathing, mindfulness, meditation, dialectical thinking, acceptance, cognitive restructuring, effective communication, behavioral activation, and meaning-making. Caregivers will complete self-report assessments (measures of emotional distress and resilience) before and after the intervention. Primary outcomes are feasibility (recruitment, quantitative measures, adherence, and therapist fidelity) and acceptability (treatment satisfaction, credibility, and expectancy). We will conduct brief qualitative exit interviews to gather feedback on refining the program and study procedures. We will examine frequencies and proportions to determine feasibility and acceptability and will analyze qualitative exit interview data using thematic analysis. We will also conduct 2-tailed t tests to explore signals of improvement in emotional distress and treatment targets. We will then conduct an explanatory-sequential mixed methods analysis to integrate quantitative and qualitative data to refine the COMA-F manual and study procedures. Results: This study has been approved by the institutional review board at 1 of the 3 enrollment centers (2023P000536), with approvals at the other 2 centers pending. We anticipate that the study will be completed by late 2024. Conclusions: We will use our findings to refine the COMA-F intervention and prepare for a feasibility randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT05761925; https://clinicaltrials.gov/study/NCT05761925 International Registered Report Identifier (IRRID): PRR1-10.2196/50860 UR - https://www.researchprotocols.org/2023/1/e50860 UR - http://dx.doi.org/10.2196/50860 UR - http://www.ncbi.nlm.nih.gov/pubmed/37878376 ID - info:doi/10.2196/50860 ER - TY - JOUR AU - Davis, A. Jacqueline AU - Ohan, L. Jeneva AU - Gregory, Sonia AU - Kottampally, Keerthi AU - Silva, Desiree AU - Prescott, L. Susan AU - Finlay-Jones, L. Amy PY - 2023/10/17 TI - Perinatal Women?s Perspectives of, and Engagement in, Digital Emotional Well-Being Training: Mixed Methods Study JO - J Med Internet Res SP - e46852 VL - 25 KW - perinatal KW - digital mental health interventions KW - well-being KW - mindfulness KW - self-compassion KW - engagement KW - ORIGINS N2 - Background: Psychological distress in the early postpartum period can have long-lasting deleterious effects on a mother?s well-being and negatively affect her infant?s development. Intervention approaches based in contemplative practices such as mindfulness and loving-kindness and compassion are intended to alleviate distress and cultivate well-being and can be delivered effectively as digital mental health interventions (DMHIs). Objective: To understand the feasibility of engaging perinatal women in digital interventions, this study aimed to document participants? experiences in the Mums Minds Matter (MMM) study, a pilot randomized controlled trial comparing mindfulness, loving-kindness and compassion, and progressive muscle relaxation training delivered in a digital format and undertaken during pregnancy. To assess the different stages of engagement during and after the intervention, we adapted the connect, attend, participate, enact (CAPE) framework that is based on the idea that individuals go through different stages of engagement before they are able to enact change. Methods: The MMM study was nested within a longitudinal birth cohort, The ORIGINS Project. We aimed to recruit 25 participants per randomization arm. Data were collected sequentially during the intervention through regular web-based surveys over 8 weeks, with opportunities to provide regular feedback. In the postintervention phase, qualitative data were collected through purposive sampling. Results: Of 310 eligible women, 84 (27.1% [connect rate]) enrolled to participate in MMM. Of the remaining 226 women who did not proceed to randomization, 223 (98.7%) failed to complete the baseline surveys and timed out of eligibility (after 30 weeks? gestation), and 3 (1.3%) displayed high psychological distress scores. Across all program groups, 17 (20% [attend rate]) of the 84 participants actively opted out, although more may have disengaged from the intervention but did not withdraw. The main reasons for withdrawal were busy life and other priorities. In this study, we assessed active engagement and ongoing skills use (participate and enact) through postintervention interviews. We undertook 15 participant interviews, conducted 1 month to 3 months after the intervention. Our results provide insights into participant barriers and enablers as well as app changes, such as the ability to choose topics, daily reminders, case studies, and diversity in sounds. Implementing a DMHI that is brief, includes frequent prompts or nudges, and is easily accessible is a key strategy to target perinatal women. Conclusions: Our research will enable future app designs that are sufficiently nuanced to maximize the uptake, engagement, and application of mental health skills and contemplative practices in the perinatal period. Providing convenient access to engaging and effective prevention programs is critical and should be part of prenatal self-care. Our research underscores the appeal and feasibility of digital intervention approaches based in contemplative practices for perinatal women. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) 12620000672954p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000672954p International Registered Report Identifier (IRRID): RR2-10.2196/19803 UR - https://www.jmir.org/2023/1/e46852 UR - http://dx.doi.org/10.2196/46852 UR - http://www.ncbi.nlm.nih.gov/pubmed/37847537 ID - info:doi/10.2196/46852 ER - TY - JOUR AU - Kirk, Ulrich AU - Staiano, Walter AU - Hu, Emily AU - Ngnoumen, Christelle AU - Kunkle, Sarah AU - Shih, Emily AU - Clausel, Alicia AU - Purvis, Clare AU - Lee, Lauren PY - 2023/10/13 TI - App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e47371 VL - 11 KW - Mindfulness KW - mental health KW - stress KW - smartphone KW - technology KW - Headspace KW - mobile phone N2 - Background: Stress-related mental health disorders have steadily increased and contributed to a worldwide disease burden with up to 50% experiencing a stress-related mental health disorder worldwide. Data suggest that only approximately 20%-65% of individuals receive treatment. This gap in receiving treatment may be attributed to barriers such as limited treatment access, negative stigma surrounding mental health treatment, approachability (ie, not having a usual treatment plan or provider), affordability (ie, lack of insurance coverage and high treatment cost), and availability (ie, long waits for appointments) leaving those who need treatment without necessary care. To mitigate the limited access mental health treatment, there has been a rise in the application and study of digital mental health interventions. As such, there is an urgent need and opportunity for effective digital mental health interventions to alleviate stress symptoms, potentially reducing adverse outcomes of stress-related disorders. Objective: This study examined if app-based guided mindfulness could improve subjective levels of stress and influence physiological markers of stress reactivity in a population with elevated symptoms of stress. Methods: The study included 163 participants who had moderate to high perceived stress as assessed by the Perceived Stress Scale (PSS-10). Participants were randomly allocated to 1 of 5 groups: a digital guided program designed to alleviate stress (Managing Stress), a digital mindfulness fundamentals course (Basics), digitally delivered breathing exercises, an active control intervention (Audiobook), and a Waitlist Control group. The 3 formats of mindfulness interventions (Managing Stress, Basics, and Breathing) all had a total duration of 300 minutes spanning 20-30 days. Primary outcome measures were perceived stress using the PSS-10, self-reported sleep quality using the Pittsburgh Sleep Quality Index, and trait mindfulness using the Mindful Attention Awareness Scale. To probe the effects of physiological stress, an acute stress manipulation task was included, specifically the cold pressor task (CPT). Heart rate variability was collected before, during, and after exposure to the CPT and used as a measure of physiological stress. Results: The results showed that PSS-10 and Pittsburgh Sleep Quality Index scores for the Managing Stress (all P<.001) and Basics (all P?.002) groups were significantly reduced between preintervention and postintervention periods, while no significant differences were reported for the other groups. No significant differences among groups were reported for Mindful Attention Awareness Scale (P=.13). The physiological results revealed that the Managing Stress (P<.001) and Basics (P=.01) groups displayed reduced physiological stress reactivity between the preintervention and postintervention periods on the CPT. There were no significant differences reported for the other groups. Conclusions: These results demonstrate efficacy of app-based mindfulness in a population with moderate to high stress on improving self-reported stress, sleep quality, and physiological measures of stress during an acute stress manipulation task. Trial Registration: ClinicalTrials.gov NCT05832632; https://www.clinicaltrials.gov/ct2/show/NCT05832632 UR - https://mhealth.jmir.org/2023/1/e47371 UR - http://dx.doi.org/10.2196/47371 UR - http://www.ncbi.nlm.nih.gov/pubmed/37831493 ID - info:doi/10.2196/47371 ER - TY - JOUR AU - Min, Beomjun AU - Park, Heyeon AU - Kim, Inhyang Johanna AU - Lee, Sungmin AU - Back, Soyoung AU - Lee, Eunhwa AU - Oh, Sohee AU - Yun, Je-Yeon AU - Kim, Bung-Nyun AU - Kim, Yonghoon AU - Hwang, JungHyun AU - Lee, Sanghyop AU - Kim, Jeong-Hyun PY - 2023/10/3 TI - The Effectiveness of a Neurofeedback-Assisted Mindfulness Training Program Using a Mobile App on Stress Reduction in Employees: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e42851 VL - 11 KW - mindfulness KW - neurofeedback KW - stress KW - resilience KW - mobile app KW - employee N2 - Background: Mindfulness-based training programs have consistently shown efficacy in stress reduction. However, questions regarding the optimal duration and most effective delivery methods remain. Objective: This research explores a 4-week neurofeedback-assisted mindfulness training for employees via a mobile app. The study?s core query is whether incorporating neurofeedback can amplify the benefits on stress reduction and related metrics compared with conventional mindfulness training. Methods: A total of 92 full-time employees were randomized into 3 groups: group 1 received mobile mindfulness training with neurofeedback assistance (n=29, mean age 39.72 years); group 2 received mobile mindfulness training without neurofeedback (n=32, mean age 37.66 years); and group 3 were given self-learning paper materials on stress management during their first visit (n=31, mean age 38.65 years). The primary outcomes were perceived stress and resilience scales. The secondary outcomes were mindfulness awareness, emotional labor, occupational stress, insomnia, and depression. Heart rate variability and electroencephalography were measured for physiological outcomes. These measurements were collected at 3 different times, namely, at baseline, immediately after training, and at a 4-week follow-up. The generalized estimating equation model was used for data analysis. Results: The 4-week program showed significant stress reduction (Wald ?22=107.167, P<.001) and improvements in psychological indices including resilience, emotional labor, insomnia, and depression. A significant interaction was observed in resilience (time × group, Wald ?42=10.846, P=.02). The post hoc analysis showed a statistically significant difference between groups 1 (least squares mean [LSM] 21.62, SE 0.55) and 3 (LSM 19.90, SE 0.61) at the posttraining assessment (P=.008). Group 1 showed a significant improvement (P<.001) at the posttraining assessment, with continued improvements through the 1-month follow-up assessment period (LSM 21.55, SE 0.61). Physiological indices were analyzed only for data of 67 participants (22 in group 1, 22 in group 2, and 23 in group 3) due to the data quality. The relaxation index (ratio of alpha to high beta power) from the right electroencephalography channel showed a significant interaction (time × group, Wald ?22=6.947, P=.03), with group 1 revealing the highest improvement (LSM 0.43, SE 0.15) compared with groups 2 (LSM ?0.11, SE 0.10) and 3 (LSM 0.12, SE 0.10) at the 1-month follow-up assessment. Conclusions: The study demonstrated that the neurofeedback-assisted group achieved superior outcomes in resilience and relaxation during the 4-week mobile mindfulness program. Further research with larger samples and long-term follow-up is warranted. Trial Registration: ClinicalTrials.gov NCT03787407; https://clinicaltrials.gov/ct2/show/NCT03787407 UR - https://mhealth.jmir.org/2023/1/e42851 UR - http://dx.doi.org/10.2196/42851 UR - http://www.ncbi.nlm.nih.gov/pubmed/37788060 ID - info:doi/10.2196/42851 ER - TY - JOUR AU - Osborne, Louise Emma AU - Ainsworth, Ben AU - Hooper, Nic AU - Atkinson, Jayne Melissa PY - 2023/9/28 TI - Experiences of Using Digital Mindfulness-Based Interventions: Rapid Scoping Review and Thematic Synthesis JO - J Med Internet Res SP - e44220 VL - 25 KW - mindfulness KW - digital intervention KW - dropout KW - eHealth KW - engagement KW - mobile health KW - mHealth KW - psychosocial intervention KW - qualitative research KW - scoping review KW - thematic synthesis KW - mobile phone N2 - Background: Digital mindfulness-based interventions (MBIs) are a promising approach to deliver accessible and scalable mindfulness training and have been shown to improve a range of health outcomes. However, the success of digital MBIs is reliant on adequate engagement, which remains a crucial challenge. Understanding people?s experiences of using digital MBIs and identifying the core factors that facilitate or act as barriers to engagement is essential to inform intervention development and maximize engagement and outcomes. Objective: This study aims to systematically map the literature on people?s experiences of using digital MBIs that target psychosocial variables (eg, anxiety, depression, distress, and well-being) and identify key barriers to and facilitators of engagement. Methods: We conducted a scoping review to synthesize empirical qualitative research on people?s experiences of using digital MBIs. We adopted a streamlined approach to ensure that the evidence could be incorporated into the early stages of intervention development. The search strategy identified articles with at least one keyword related to mindfulness, digital, user experience, and psychosocial variables in their title or abstract. Inclusion criteria specified that articles must have a qualitative component, report on participants? experiences of using a digital MBI designed to improve psychosocial variables, and have a sample age range that at least partially overlapped with 16 to 35 years. Qualitative data on user experience were charted and analyzed using inductive thematic synthesis to generate understandings that go beyond the content of the original studies. We used the Quality of Reporting Tool to critically appraise the included sources of evidence. Results: The search identified 530 studies, 22 (4.2%) of which met the inclusion criteria. Overall, the samples were approximately 78% female and 79% White; participants were aged between 16 and 69 years; and the most used measures in intervention studies were mindfulness, psychological flexibility, and variables related to mental health (including depression, anxiety, stress, and well-being). All studies were judged to be adequately reported. We identified 3 themes characterizing barriers to and facilitators of engagement: responses to own practice (ie, negative reactions to one?s own practice are common and can deplete motivation), making mindfulness a habit (ie, creating a consistent training routine is essential yet challenging), and leaning on others (ie, those engaging depend on someone else for support). Conclusions: The themes identified in this review provide crucial insights as to why people frequently stop engaging with digital MBIs. Researchers and developers should consider using person-based coparticipatory methods to improve acceptability of and engagement with digital MBIs, increase their effectiveness, and support their translation to real-world use. Such strategies must be grounded in relevant literature and meet the priorities and needs of the individuals who will use the interventions. UR - https://www.jmir.org/2023/1/e44220 UR - http://dx.doi.org/10.2196/44220 UR - http://www.ncbi.nlm.nih.gov/pubmed/37768709 ID - info:doi/10.2196/44220 ER - TY - JOUR AU - Cearns, Micah AU - Clark, R. Scott PY - 2023/9/19 TI - The Effects of Dose, Practice Habits, and Objects of Focus on Digital Meditation Effectiveness and Adherence: Longitudinal Study of 280,000 Digital Meditation Sessions Across 103 Countries JO - J Med Internet Res SP - e43358 VL - 25 KW - mindfulness KW - meditation KW - digital meditation KW - mindfulness dose-response KW - meditation dose-response KW - dose-response KW - meditation adherence KW - mindfulness adherence KW - longitudinal meditation research KW - outcome KW - ecological memory assessment KW - mental well-being KW - healthy lifestyle KW - digital health intervention N2 - Background: The efficacy of digital meditation is well established. However, the extent to which the benefits remain after 12 weeks in real-world settings remains unknown. Additionally, findings related to dosage and practice habits have been mixed, and the studies were conducted on small and homogeneous samples and used a limited range of analytical procedures and meditation techniques. Findings related to the predictors of adherence are also lacking and may help inform future meditators and meditation programs on how to best structure healthy sustainable practices. Objective: This study aimed to measure outcome change across a large and globally diverse population of meditators and meditations in their naturalistic practice environments, assess the dose-response relationships between practice habits and outcome change, and identify predictors of adherence. Methods: We used ecological momentary assessment to assess participants? well-being over a 14-month period. We engineered outcomes related to the variability of change over time (equanimity) and recovery following a drop in mood (resilience) and established the convergent and divergent validity of these outcomes using a validated scale. Using linear mixed-effects and generalized additive mixed-effects models, we modeled outcome changes and patterns of dose-response across outcomes. We then used logistic regression to study the practice habits of participants in their first 30 sessions to derive odds ratios of long-term adherence. Results: Significant improvements were observed in all outcomes (P<.001). Generalized additive mixed models revealed rapid improvements over the first 50-100 sessions, with further improvements observed until the end of the study period. Outcome change corresponded to 1 extra day of improved mood for every 5 days meditated and half-a-day-faster mood recovery compared with baseline. Overall, consistency of practice was associated with the largest outcome change (4-7 d/wk). No significant differences were observed across session lengths in linear models (mood: P=.19; equanimity: P=.10; resilience: P=.29); however, generalized additive models revealed significant differences over time (P<.001). Longer sessions (21-30 min) were associated with the largest magnitude of change in mood from the 20th session onward and fewer sessions to recovery (increased resilience); midlength sessions (11-20 min) were associated with the largest decreases in recovery; and mood stability was similar across session lengths (equanimity). Completing a greater variety of practice types was associated with significantly greater improvements across all outcomes. Adhering to a long-term practice was best predicted by practice consistency (4-7 d/wk), a morning routine, and maintaining an equal balance between interoceptive and exteroceptive meditations. Conclusions: Long-term real-world digital meditation practice is effective and associated with improvements in mood, equanimity, and resilience. Practice consistency and variety rather than length best predict improvement. Long-term sustainable practices are best predicted by consistency, a morning routine, and a practice balanced across objects of focus that are internal and external to the body. UR - https://www.jmir.org/2023/1/e43358 UR - http://dx.doi.org/10.2196/43358 UR - http://www.ncbi.nlm.nih.gov/pubmed/37725801 ID - info:doi/10.2196/43358 ER - TY - JOUR AU - Hedbom, Towe AU - Liljeroos, Maria AU - Thylén, Ingela AU - Orwelius, Lotti AU - Jaarsma, Tiny AU - Strömberg, Anna PY - 2023/9/13 TI - Expectations of Tele-Yoga in Persons With Long-Term Illness: Qualitative Content Analysis JO - J Med Internet Res SP - e36808 VL - 25 KW - yoga KW - telerehabilitation KW - eHealth KW - chronic illness KW - heart failure KW - implantable cardioverter defibrillator KW - postintensive care N2 - Background: Yoga is a mind-body exercise that has demonstrated its feasibility and safety even for individuals with severe long-term illness. Engaging in yoga has the potential to yield positive effects on both physical and mental well-being. Tele-yoga is a novel approach to rehabilitation in which participants practice group yoga with a live-streamed yoga instructor digitally via a tablet. This is especially beneficial for individuals who may find it difficult to leave their homes to participate in an exercise session. As part of our ongoing evaluation of the tele-yoga intervention in individuals with long-term illness, we have undertaken an exploration of participants? expectations regarding yoga in general and tele-yoga specifically. Understanding these expectations is crucial, as they can significantly impact their satisfaction with treatment and care and influence overall intervention outcomes. Objective: This study aims to explore the expectations of tele-yoga among individuals with long-term illness before starting a tele-yoga intervention. Methods: The study employed an inductive qualitative design and is part of a process evaluation within an ongoing randomized controlled trial. A total of 89 participants were interviewed before the start of the tele-yoga intervention. The interview guide encompassed questions about their general perceptions of yoga and the specific expectations they held for the upcoming tele-yoga sessions. The interviews were transcribed and analyzed using inductive qualitative content analysis. Results: Participants expressed their expectations for tele-yoga, focusing on the anticipated improvements in physical function and overall health. These expectations included hopes for reduced respiratory issues; relief from discomfort, aches, and pains; as well as increased physical flexibility, coordination, and overall well-being. Besides, they expected to achieve improved psychological well-being and performance; to acquire strategies to manage stress, anger, and anxiety; and to have their motivational drive strengthened and influence other activities. Participants described tele-yoga as a new and exciting technical solution that would facilitate the delivery of yoga. A few participants remained a little hesitant toward the use of technology, with some expectations based on previous experiences. When asked about expectations, some had no idea about what to expect. Participants also had varying perspectives on yoga, with some finding it mysterious and difficult to understand. Participants expressed thoughts that they found the idea of tele-yoga taking place in groups exciting and enjoyable. They also had expectations that being part of a group would provide opportunities for mutual inspiration and encouragement among the group members. Conclusions: Expectations before an intervention can provide valuable insights into understanding the factors influencing adherence to tele-yoga and its outcomes. Our findings provide a wide range of expectations for tele-yoga, spanning both physical and mental aspects. Moreover, the technology?s potential to facilitate yoga delivery and the supportive nature of digital group interactions were evident from the results. Trial Registration: ClinicalTrials.gov NCT03703609; https://clinicaltrials.gov/ct2/show/NCT03703609 UR - https://www.jmir.org/2023/1/e36808 UR - http://dx.doi.org/10.2196/36808 UR - http://www.ncbi.nlm.nih.gov/pubmed/37703082 ID - info:doi/10.2196/36808 ER - TY - JOUR AU - Listiyandini, Arruum Ratih AU - Andriani, Annisa AU - Kusristanti, Chandradewi AU - Moulds, Michelle AU - Mahoney, Alison AU - Newby, M. Jill PY - 2023/8/31 TI - Culturally Adapting an Internet-Delivered Mindfulness Intervention for Indonesian University Students Experiencing Psychological Distress: Mixed Methods Study JO - JMIR Form Res SP - e47126 VL - 7 KW - psychological distress KW - mindfulness KW - cultural adaptation KW - internet-delivered KW - students KW - Indonesia KW - mobile phone N2 - Background: Psychological distress is prevalent among university students. However, the availability of evidence-based mental health treatment remains limited in many low- and middle-income countries, including Indonesia. Internet-delivered, mindfulness-based interventions that reduce distress have potential for treating university student distress at scale. Unfortunately, evidence-based, internet-delivered mindfulness treatments are not yet available in Indonesia. Cultural adaptation of established evidence-based, internet-delivered mindfulness interventions is needed. Objective: In this paper, we describe the process of culturally adapting an Australian internet-delivered mindfulness program (Introduction to Mindfulness) to be relevant and appropriate for treating Indonesian university students? psychological distress. Methods: To assist the cultural adaptation process, we used a systematic cultural adaptation framework and a mixed methods approach combining quantitative and qualitative methods. In study 1 (information gathering), we administered an internet-delivered questionnaire to Indonesian university students (n=248) to examine their preferences regarding an internet-delivered mindfulness intervention. In study 2 (preliminary design), a draft program was developed and independently reviewed by Indonesian stakeholders. Stakeholders (n=25) included local Indonesian mindfulness and mental health professionals (n=6) and university students (n=19), who were selected to maximize sample representativeness regarding personal and professional characteristics. To evaluate the initial design and cultural congruence of the internet-delivered mindfulness program in the Indonesian context, we conducted interviews and focus groups with stakeholders. Stakeholders also completed the Cultural Relevance Questionnaire. Results: In study 1, most Indonesian university students (240/248, 96.8%) reported openness to an internet-delivered mindfulness program. Most of interested students (127/240, 52.9%) preferred the length of the program to be 3 to 4 sessions, with 45.8% (110/240) preferring brief lessons taking only 15 to 30 minutes to complete. They (194/240, 80.8%) recommended that the program be accessible both through websites and mobile phones. In study 2, Indonesian stakeholders generally found the internet-delivered program to be highly culturally appropriate in terms of language, concepts, context, treatment goals, and depictions of students? emotional and behavioral experiences. However, stakeholders also recommended some specific adaptations regarding the program?s delivery model (eg, combining visual and audio modalities when delivering psychoeducation), cultural components (eg, including more social and spiritual activities), program practicality (eg, including rewards to promote engagement), and design elements (eg, including additional culturally relevant illustrations). Following stakeholder feedback, a new culturally adapted Indonesian internet-delivered mindfulness program called Program Intervensi Mindfulness Daring Mahasiswa Indonesia was created. Conclusions: This study highlights the process and importance of cultural adaptation of an evidence-based mindfulness treatment and demonstrates how this may be achieved for internet-delivered psychotherapy programs. We found that a culturally adapted internet-delivered mindfulness program was relevant for Indonesian students with some adjustments to the programs? content and delivery. Future research is now needed to evaluate the clinical benefit of this program. UR - https://formative.jmir.org/2023/1/e47126 UR - http://dx.doi.org/10.2196/47126 UR - http://www.ncbi.nlm.nih.gov/pubmed/37651168 ID - info:doi/10.2196/47126 ER - TY - JOUR AU - Schwartz, Katrin AU - Ganster, Marie Fabienne AU - Tran, S. Ulrich PY - 2023/8/4 TI - Mindfulness-Based Mobile Apps and Their Impact on Well-Being in Nonclinical Populations: Systematic Review of Randomized Controlled Trials JO - J Med Internet Res SP - e44638 VL - 25 KW - mindfulness KW - well-being KW - mobile app KW - systematic review KW - randomized controlled trial KW - RCT KW - mobile phone N2 - Background: Mindfulness-based mobile apps have become popular tools for enhancing well-being in today?s fast-paced world. Their ability to reduce geographical, financial, and social barriers makes them a promising alternative to traditional interventions. Objective: As most available apps lack a theoretical framework, this review aimed to evaluate their effectiveness and assess their quality. We expected to find small sample sizes, high dropout rates, and small effect sizes in the included studies. Methods: A systematic literature search was conducted using PsycInfo, PsycNet, PubMed, an institutional search engine (u:search), and Google Scholar. Randomized controlled trials assessing the impact of mobile mindfulness apps on well-being in nonclinical samples were included. Study selection, risk of bias (using the version 2 of the Cochrane risk-of-bias tool for randomized trials), and reporting quality (using selected CONSORT [Consolidated Standards of Reporting Trials] statement criteria) assessments were performed by 2 authors independently and discussed until a consensus was reached. Results: The 28 included randomized controlled trials differed in well-being measures, apps, and intervention duration (7 to 56 days; median duration 28 days). A wide range of sample sizes (12 to 2282; median 161) and attrition rates (0% to 84.7%; median rate 23.4%) were observed. Most studies (19/28, 68%) reported positive effects on at least one aspect of well-being. The effects were presented using different metrics but were primarily small or small to medium in size. Overall risk of bias was mostly high. Conclusions: The wide range of sample sizes, attrition rates, and intervention periods and the variation in well-being measures and mobile apps contributed to the limited comparability of the studies. Although most studies (16/28, 57%) reported small or small to medium effects for at least one well-being outcome, this review demonstrates that the generalizability of the results is limited. Further research is needed to obtain more consistent conclusions regarding the impact of mindfulness-based mobile apps on well-being in nonclinical populations. UR - https://www.jmir.org/2023/1/e44638 UR - http://dx.doi.org/10.2196/44638 UR - http://www.ncbi.nlm.nih.gov/pubmed/37540550 ID - info:doi/10.2196/44638 ER - TY - JOUR AU - Silveira, Sarita AU - Godara, Malvika AU - Singer, Tania PY - 2023/7/26 TI - Boosting Empathy and Compassion Through Mindfulness-Based and Socioemotional Dyadic Practice: Randomized Controlled Trial With App-Delivered Trainings JO - J Med Internet Res SP - e45027 VL - 25 KW - mental training KW - compassion KW - empathy KW - mindfulness KW - dyadic practice KW - acceptance KW - digital mental health KW - self-compassion KW - app-delivered training KW - Affect Dyad KW - mobile phone N2 - Background: Contemplative trainings have been found to effectively improve social skills such as empathy and compassion. However, there is a lack of research on the efficacy of app-delivered mindfulness-based and dyadic practices in boosting socioaffective capacity. Objective: The first aim of this study was to compare a novel app-delivered, partner-based socioemotional intervention (Affect Dyad) with mindfulness-based training to foster empathy and compassion for the self or others. The second aim of this study was to investigate the underlying mechanisms of these effects. Methods: This randomized controlled trial included socioemotional and mindfulness-based interventions and a waitlist control group, which received socioemotional training after the postintervention assessment. We used linear mixed-effects models to test intervention effects on self-report measures and an ecologically valid computer task of empathy, compassion for the self and others, and theory of mind. Moderated mediation models were used to investigate whether changes in acceptance, empathic distress, empathic listening, interoceptive awareness, and mindfulness served as underlying psychological processes of intervention effects. Results: In 218 participants (mean age 44.12, SD 11.71 years; 160/218, 73.4% female), we found all interventions to have positive effects on composite scores for compassion toward the self (?socioemotional=.44, P<.001; ?waitlist socioemotional=.30, P=.002; ?mindfulness-based=.35, P<.001) and others (?socioemotional=.24, P=.003; ?waitlist socioemotional=.35, P<.001; ?mindfulness-based=.29, P<.001). Compassion measured with the computer task did not change significantly but showed a trend toward increase only in socioemotional dyadic practice (?socioemotional=.08, P=.08; ?waitlist socioemotional=.11, P=.06). Similarly, on the empathic concern subscale of the Interpersonal Reactivity Index, a nonsignificant trend toward increase was found in the socioemotional intervention group (?socioemotional=.17; P=.08). Empathy significantly increased in both socioemotional groups (?socioemotional=.16, P=.03; ?waitlist socioemotional=.35, P<.001) and the mindfulness-based group (?mindfulness-based=.15; P=.04). The measures of theory of mind did not change over time. In the mindfulness-based group, the increase in self-compassion was mediated by a decrease in empathic distress (indirect effect abmindfulness-based=0.07, 95% CI 0.02-0.14). In the socioemotional group, an increase in self-compassion could be predicted by an increase in acceptance (?socioemotional=6.63, 95% CI 0.52-12.38). Conclusions: Using a multimethod approach, this study shows that app-delivered socioemotional and mindfulness-based trainings are effective in fostering compassion for the self and others in self-report. Both low-dose trainings could boost behavioral empathy markers; however, the effects on behavioral and dispositional markers of compassion only trended after dyadic practice, yet these effects did not reach statistical significance. Training-related increases in self-compassion rely on differential psychological processes, that is, on improved empathic distress regulation through mindfulness-based training and the activation of a human care? and acceptance-based system through socioemotional dyadic training. Trial Registration: ClinicalTrials.gov NCT04889508; https://clinicaltrials.gov/ct2/show/NCT04889508 UR - https://www.jmir.org/2023/1/e45027 UR - http://dx.doi.org/10.2196/45027 UR - http://www.ncbi.nlm.nih.gov/pubmed/37494106 ID - info:doi/10.2196/45027 ER - TY - JOUR AU - Sommerhoff, Amanda AU - Ehring, Thomas AU - Takano, Keisuke PY - 2023/7/19 TI - Effects of Induced Mindfulness at Night on Repetitive Negative Thinking: Ecological Momentary Assessment Study JO - JMIR Ment Health SP - e44365 VL - 10 KW - mindfulness KW - repetitive negative thinking KW - stress KW - daily life KW - ecological momentary assessment KW - mobile phone N2 - Background: Repetitive negative thinking (RNT) is a cognitive risk factor for various disorders. Although brief mindfulness-based interventions (MBIs; lasting 20-30 minutes or shorter) are effective tools to reduce RNT, the effect of a minimal (5-minute) MBI remains largely unknown. Objective: We investigated the acute changes in RNT induced by a 10-day minimal MBI (body scan before sleeping) using an ecological momentary assessment (EMA) administered during the MBI training phase. In addition, we examined longer-term effects on the postintervention and 2-month follow-up assessments for questionnaire-based RNT and psychological distress. Methods: A total of 68 participants (community sample, aged 18-55 years; n=58, 85% women) were randomly allocated to either the intervention group (n=35, 51%) or the no-training control group (n=33, 49%). Both groups completed a 10-day EMA phase of RNT, during which only the intervention group performed a daily 5-minute body scan before sleeping. Results: The intervention group showed a significantly larger reduction in questionnaire-based RNT than the control group at the follow-up assessment (for growth-curve modeling analysis [GMA], dGMA=?0.91; P<.001), but this effect was not observed during the EMA phase or at the postintervention assessment. Furthermore, the intervention group showed significantly larger decreases in stress both at the postintervention (dGMA=?0.78; P<.001) and follow-up (dGMA=?0.60; P<.001) assessments than the control group. We found no intervention effects on depressive and anxiety symptoms. Conclusions: A 5-minute body scan before sleeping reduces RNT and stress when continued for at least 10 days; however, the results suggest that this effect only appears with some time lag because no acute changes during and immediately after the intervention emerged for RNT. UR - https://mental.jmir.org/2023/1/e44365 UR - http://dx.doi.org/10.2196/44365 UR - http://www.ncbi.nlm.nih.gov/pubmed/37467038 ID - info:doi/10.2196/44365 ER - TY - JOUR AU - Portz, Dickman Jennifer AU - Schmid, Arlene AU - Fruhauf, Christine AU - Fox, Aimee AU - Van Puymbroeck, Marieke AU - Sharp, Julia AU - Leach, Heather PY - 2023/5/24 TI - Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study JO - JMIR Form Res SP - e39158 VL - 7 KW - yoga KW - meditative movement KW - online KW - chronic conditions KW - self-management KW - caregiver KW - dyads KW - meditation KW - participation KW - perspective KW - intervention N2 - Background: The online delivery of yoga interventions rapidly expanded during the COVID-19 pandemic, and preliminary studies indicate that online yoga is feasible across multiple chronic conditions. However, few yoga studies provide synchronous online yoga sessions and rarely target the caregiving dyad. Online chronic disease management interventions have been evaluated across conditions, life spans, and diverse samples. However, the perceived acceptability of online yoga, including self-reported satisfaction and online delivery preferences, is underexplored among individuals with chronic conditions and their caregivers. Understanding user preferences is essential for successful and safe online yoga implementation. Objective: We aimed to qualitatively examine the perceived acceptability of online yoga among individuals with chronic conditions and their caregivers who participated in an online dyadic intervention that merged yoga and self-management education to develop skills (MY-Skills) to manage persistent pain. Methods: We conducted a qualitative study among 9 dyads (>18 years of age; individuals experiencing persistent moderate pain) who participated in MY-Skills online during the COVID-19 pandemic. The intervention consisted of 16 online, synchronous yoga sessions over 8 weeks for both dyad members. After the completion of the intervention, participants (N=18) participated in semistructured telephone interviews for around 20 minutes, discussing their preferences, challenges, and recommendations for improved online delivery. Interviews were analyzed by using a rapid analytic approach. Results: MY-Skills participants were, on average, aged 62.7 (SD 19) years; were primarily women; were primarily White; and had a mean of 5.5 (SD 3) chronic conditions. Both participants and caregivers reported moderate pain severity scores (mean 6.02, SD 1.3) on the Brief Pain Inventory. The following three themes were identified related to online delivery: (1) participants indicated a preference for the intervention to be in person rather than online because they were distracted in the home setting, because they felt that in-person yoga would be more engaging, because the yoga therapist could physically correct positions, and because of safety concerns (eg, fear of falling); (2) participants indicated good acceptability of online MY-Skills delivery due to convenience, access, and comfort with being in their home; and (3) recommendations for improving online delivery highlighted a need for additional and accessible technical support. Conclusions: Both individuals with chronic conditions and their caregivers find online yoga to be an acceptable intervention. Participants who preferred in-person yoga did so due to distractions in the home and group dynamics. Some participants preferred in-person corrections to ensure correct positioning, while others felt safe with verbal modifications in their homes. Convenience and access were the primary reasons for preferring online delivery. To improve online delivery, future yoga studies should include specific activities for fostering group engagement, enhancing safety protocols, and increasing technical support. Trial Registration: ClinicalTrials.gov NCT03440320; https://clinicaltrials.gov/ct2/show/NCT03440320 UR - https://formative.jmir.org/2023/1/e39158 UR - http://dx.doi.org/10.2196/39158 UR - http://www.ncbi.nlm.nih.gov/pubmed/37223971 ID - info:doi/10.2196/39158 ER - TY - JOUR AU - He, Ying AU - Tang, Zhijie AU - Sun, Guozhen AU - Cai, Cheng AU - Wang, Yao AU - Yang, Gang AU - Bao, ZhiPeng PY - 2023/5/3 TI - Effectiveness of a Mindfulness Meditation App Based on an Electroencephalography-Based Brain-Computer Interface in Radiofrequency Catheter Ablation for Patients With Atrial Fibrillation: Pilot Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e44855 VL - 11 KW - atrial fibrillation KW - radiofrequency catheter ablation KW - mindfulness meditation KW - brain computer interface KW - mHealth KW - smartphone app KW - randomized controlled trial N2 - Background: Radiofrequency catheter ablation (RFCA) for patients with atrial fibrillation (AF) can generate considerable physical and psychological discomfort under conscious sedation. App-based mindfulness meditation combined with an electroencephalography (EEG)-based brain-computer interface (BCI) shows promise as effective and accessible adjuncts in medical practice. Objective: This study aimed to investigate the effectiveness of a BCI-based mindfulness meditation app in improving the experience of patients with AF during RFCA. Methods: This single-center pilot randomized controlled trial involved 84 eligible patients with AF scheduled for RFCA, who were randomized 1:1 to the intervention and control groups. Both groups received a standardized RFCA procedure and a conscious sedative regimen. Patients in the control group were administered conventional care, while those in the intervention group received BCI-based app?delivered mindfulness meditation from a research nurse. The primary outcomes were the changes in the numeric rating scale, State Anxiety Inventory, and Brief Fatigue Inventory scores. Secondary outcomes were the differences in hemodynamic parameters (heart rate, blood pressure, and peripheral oxygen saturation), adverse events, patient-reported pain, and the doses of sedative drugs used in ablation. Results: BCI-based app?delivered mindfulness meditation, compared to conventional care, resulted in a significantly lower mean numeric rating scale (mean 4.6, SD 1.7 [app-based mindfulness meditation] vs mean 5.7, SD 2.1 [conventional care]; P=.008), State Anxiety Inventory (mean 36.7, SD 5.5 vs mean 42.3, SD 7.2; P<.001), and Brief Fatigue Inventory (mean 3.4, SD 2.3 vs mean 4.7, SD 2.2; P=.01) scores. No significant differences were observed in hemodynamic parameters or the amounts of parecoxib and dexmedetomidine used in RFCA between the 2 groups. The intervention group exhibited a significant decrease in fentanyl use compared to the control group, with a mean dose of 3.96 (SD 1.37) mcg/kg versus 4.85 (SD 1.25) mcg/kg in the control group (P=.003).The incidence of adverse events was lower in the intervention group (5/40) than in the control group (10/40), though this difference was not significant (P=.15). Conclusions: BCI-based app?delivered mindfulness meditation effectively relieved physical and psychological discomfort and may reduce the doses of sedative medication used in RFCA for patients with AF. Trial Registration: ClinicalTrials.gov NCT05306015; https://clinicaltrials.gov/ct2/show/NCT05306015 UR - https://mhealth.jmir.org/2023/1/e44855 UR - http://dx.doi.org/10.2196/44855 UR - http://www.ncbi.nlm.nih.gov/pubmed/37133926 ID - info:doi/10.2196/44855 ER - TY - JOUR AU - Emezue, Chuka AU - Karnik, S. Niranjan AU - Reeder, Blaine AU - Schoeny, Michael AU - Layfield, Rickey AU - Zarling, Amie AU - Julion, Wrenetha PY - 2023/5/1 TI - A Technology-Enhanced Intervention for Violence and Substance Use Prevention Among Young Black Men: Protocol for Adaptation and Pilot Testing JO - JMIR Res Protoc SP - e43842 VL - 12 KW - youth KW - violence KW - adolescent health KW - mindfulness KW - digital health KW - usability KW - Black KW - African American KW - men KW - mobile app N2 - Background: Black boys and men from disinvested communities are disproportionately survivors and perpetrators of youth violence. Those presenting to emergency departments with firearm-related injuries also report recent substance use. However, young Black men face several critical individual and systemic barriers to accessing trauma-focused prevention programs. These barriers contribute to service avoidance, the exacerbation of violence recidivism, substance use relapse, and a revolving-door approach to prevention. In addition, young Black men are known to be digital natives. Therefore, technology-enhanced interventions offer a pragmatic and promising opportunity to mitigate these barriers, provide vital life skills for self-led behavior change, and boost service engagement with vital community resources. Objective: The study aims to systematically adapt and pilot-test Boosting Violence-Related Outcomes Using Technology for Empowerment, Risk Reduction, and Life Skills Preparation in Youth Based on Acceptance and Commitment Therapy (BrotherlyACT), a culturally congruent, trauma-focused digital psychoeducational and service-engagement tool tailored to young Black men aged 15-24 years. BrotherlyACT will incorporate microlearning modules, interactive safety planning tools for risk assessment, goal-setting, mindfulness practice, and a service-engagement conversational agent or chatbot to connect young Black men to relevant services. Methods: The development of BrotherlyACT will occur in 3 phases. In phase 1, we will qualitatively investigate barriers and facilitators influencing young Black men?s willingness to use violence and substance use prevention services with 15-30 young Black men (aged 15-24 years) who report perpetrating violence and substance use in the past year and 10 service providers (aged >18 years; any gender; including health care providers, street outreach workers, social workers, violence interrupters, community advocates, and school staff). Both groups will be recruited from community and pediatric emergency settings. In phase 2, a steering group of topic experts (n=3-5) and a youth and community advisory board comprising young Black men (n=8-12) and service providers (n=5-10) will be involved in participatory design, alpha testing, and beta testing sessions to develop, refine, and adapt BrotherlyACT based on an existing skills-based program (Achieving Change Through Values-Based Behavior). We will use user-centered design principles and the Assessment, Decision, Administration, Production, Topical, Experts, Integration, Training, and Testing framework to guide this adaptation process (phase 2). In phase 3, a total of 60 young Black men will pilot-test the adapted BrotherlyACT over 10 weeks in a single-group, pretest-posttest design to determine its feasibility and implementation outcomes. Results: Phase 1 data collection began in September 2021. Phases 2 and 3 are scheduled to start in June 2023 and end in September 2024. Conclusions: The development and testing of BrotherlyACT is a crucial first step in expanding an evidence-based psychoeducational and service-mediating intervention for young Black men involved in violence. This colocation of services shifts the current prevention strategy from telling them why to change to teaching them how. International Registered Report Identifier (IRRID): PRR1-10.2196/43842 UR - https://www.researchprotocols.org/2023/1/e43842 UR - http://dx.doi.org/10.2196/43842 UR - http://www.ncbi.nlm.nih.gov/pubmed/37126388 ID - info:doi/10.2196/43842 ER - TY - JOUR AU - Lam, U. Sin AU - Xie, Qiang AU - Goldberg, B. Simon PY - 2023/4/28 TI - Situating Meditation Apps Within the Ecosystem of Meditation Practice: Population-Based Survey Study JO - JMIR Ment Health SP - e43565 VL - 10 KW - mindfulness KW - meditation KW - consumer behavior KW - user engagement KW - mobile health KW - digital health KW - mobile phone N2 - Background: Meditation apps have the potential to increase access to evidence-based strategies to promote mental health. However, it is currently unclear how meditation apps are situated within the broader landscape of meditation practice and what factors may influence engagement with them. Objective: This study aimed to clarify the prevalence and correlates of meditation app use in a population-based sample of individuals with lifetime exposure to meditation in the United States. In addition, we sought to identify the concerns and desired features of meditation apps among those with lifetime exposure to meditation. Methods: A total of 953 participants completed an initial screening survey. Of these 953 participants, 434 (45.5%) reported lifetime exposure to meditation and completed a follow-up survey (434/470, 92.3% response rate) assessing their meditation app use, anxiety, depression, loneliness, initial motivation for meditation, and concerns about and desired features of meditation apps. Results: Almost half (434/953, 45.5%) of the participants who completed the screening survey reported lifetime exposure to meditation. Among those with lifetime exposure to meditation (ie, meditators), more than half (255/434, 58.8%) had used meditation apps at least once in their lives, and 21.7% (94/434) used meditation apps weekly or daily (ie, active users). Younger age, higher anxiety, and a mental health motivation for practicing meditation were associated with lifetime exposure to meditation apps. Among meditators, those with lifetime exposure to meditation apps were more likely to report concerns about apps, including concerns regarding the cost and effectiveness of apps, time required for use, technical issues with apps, and app user-friendliness. Meditators who used meditation apps weekly or daily (ie, active users) were younger, less likely to be men and non-Latinx White individuals and have lower income, and more likely to have an initial spiritual motivation for meditation. Active users reported more concerns regarding usability and technical problems and were less likely to report disinterest in apps. Headspace and Calm were the most frequently used apps. Tips and reminders for practice, encouragement of ?mini? practices, and mental health content were the most desired features. Participants were less interested in social features (eg, the ability to communicate with other users or teachers). Conclusions: Meditation apps are commonly used by meditators in the United States, with a higher use among certain demographic groups. Future studies may increase user engagement in meditation apps by addressing concerns (eg, cost and effectiveness) and incorporating desired features (eg, tips and reminders for practice). UR - https://mental.jmir.org/2023/1/e43565 UR - http://dx.doi.org/10.2196/43565 UR - http://www.ncbi.nlm.nih.gov/pubmed/37115618 ID - info:doi/10.2196/43565 ER - TY - JOUR AU - Stecher, Chad AU - Cloonan, Sara AU - Linnemayr, Sebastian AU - Huberty, Jennifer PY - 2023/4/28 TI - Combining Behavioral Economics?Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e39930 VL - 12 KW - habits KW - mindfulness meditation KW - mobile apps KW - mobile health KW - mHealth KW - adherence KW - meditation KW - mindfulness KW - intervention KW - apps KW - smartphone apps KW - stress KW - management KW - mobile phone N2 - Background: Chronic (ie, long-term) elevated stress is associated with a number of mental and physical health conditions. Mindfulness meditation mobile apps are a promising tool for stress self-management that can overcome several barriers associated with in-person interventions; however, to date, poor app-based intervention adherence has limited the efficacy of these mobile health tools. Anchoring, or pairing, a new behavior with an existing routine has been shown to effectively establish habits that are maintained over time, but this strategy typically only works for those with high initial motivation and has yet to be tested for maintaining meditation with a mobile app. Objective: This study will test novel combinations of behavioral economics?based incentives with the anchoring strategy for establishing and maintaining adherence to an effective dose of meditation with a mobile app. Methods: This 16-week study will use a 5-arm, parallel, partially blinded (participants only), randomized controlled design. We will implement a fractional factorial study design that varies the use of self-monitoring messages and financial incentives to support participants? use of their personalized anchoring strategy for maintaining adherence to a ?10 minute-per-day meditation prescription during an 8-week intervention period, followed by an 8-week postintervention observation period. Specifically, we will vary the use of self-monitoring messages of either the target behavior (ie, meditation tracking) or the outcome associated with the target behavior (ie, mood symptom tracking). We will also vary the use of financial incentives conditional on either meditation at any time of day or meditation performed at approximately the same time of day as participants? personalized anchors. Results: Continuous meditation app use data will be used to measure weekly meditation adherence over the 16-week study period as a binary variable equal to 1 if participants complete ?10 minutes of meditation for ?4 days per week and 0 otherwise. We will measure weekly anchoring plan adherence as a binary variable equal to 1 if participants complete ?10 minutes of meditation within +1 or ?1 hour of the timing of their chosen anchor on ?4 days per week and 0 otherwise. In addition to these primary measures of meditation and anchoring plan adherence, we will also assess the secondary measures of stress, anxiety, posttraumatic stress disorder, sleep disturbance, and meditation app habit strength at baseline, week 8, and week 16. Conclusions: This study will fill an important gap in the mobile health literature by testing novel intervention approaches for establishing and maintaining adherence to app-based mindfulness meditation. If successful, this study will identify an accessible and scalable stress self-management intervention that can help combat stress in the United States. Trial Registration: ClinicalTrials.gov NCT05217602; https://clinicaltrials.gov/ct2/show/NCT05217602 International Registered Report Identifier (IRRID): DERR1-10.2196/39930 UR - https://www.researchprotocols.org/2023/1/e39930 UR - http://dx.doi.org/10.2196/39930 UR - http://www.ncbi.nlm.nih.gov/pubmed/37115610 ID - info:doi/10.2196/39930 ER - TY - JOUR AU - Berardi, Vincent AU - Fowers, Rylan AU - Rubin, Gavriella AU - Stecher, Chad PY - 2023/4/10 TI - Time of Day Preferences and Daily Temporal Consistency for Predicting the Sustained Use of a Commercial Meditation App: Longitudinal Observational Study JO - J Med Internet Res SP - e42482 VL - 25 KW - behavioral habits KW - habit formation KW - mindfulness meditation KW - mobile health KW - health app KW - app usage KW - meditation app KW - temporal analysis KW - circadian rhythm KW - healthy life style KW - physical activity KW - mental well being KW - habit KW - mindfulness KW - meditation KW - wellbeing KW - mental health KW - longitudinal KW - observational KW - advice KW - morning N2 - Background: The intensive data typically collected by mobile health (mHealth) apps allows factors associated with persistent use to be investigated, which is an important objective given users? well-known struggles with sustaining healthy behavior. Objective: Data from a commercial meditation app (n=14,879; 899,071 total app uses) were analyzed to assess the validity of commonly given habit formation advice to meditate at the same time every day, preferably in the morning. Methods: First, the change in probability of meditating in 4 nonoverlapping time windows (morning, midday, evening, and late night) on a given day over the first 180 days after creating a meditation app account was calculated via generalized additive mixed models. Second, users? time of day preferences were calculated as the percentage of all meditation sessions that occurred within each of the 4 time windows. Additionally, the temporal consistency of daily meditation behavior was calculated as the entropy of the timing of app usage sessions. Linear regression was used to examine the effect of time of day preference and temporal consistency on two outcomes: (1) short-term engagement, defined as the number of meditation sessions completed within the sixth and seventh month of a user?s account, and (2) long-term use, defined as the days until a user?s last observed meditation session. Results: Large reductions in the probability of meditation at any time of day were seen over the first 180 days after creating an account, but this effect was smallest for morning meditation sessions (63.4% reduction vs reductions ranging from 67.8% to 74.5% for other times). A greater proportion of meditation in the morning was also significantly associated with better short-term engagement (regression coefficient B=2.76, P<.001) and long-term use (B=50.6, P<.001). The opposite was true for late-night meditation sessions (short-term: B=?2.06, P<.001; long-term: B=?51.7, P=.001). Significant relationships were not found for midday sessions (any outcome) or for evening sessions when examining long-term use. Additionally, temporal consistency in the performance of morning meditation sessions was associated with better short-term engagement (B=?1.64, P<.001) but worse long-term use (B=55.8, P<.001). Similar-sized temporal consistency effects were found for all other time windows. Conclusions: Meditating in the morning was associated with higher rates of maintaining a meditation practice with the app. This is consistent with findings from other studies that have hypothesized that the strength of existing morning routines and circadian rhythms may make the morning an ideal time to build new habits. In the long term, less temporal consistency in meditation sessions was associated with more persistent app use, suggesting there are benefits from maintaining flexibility in behavior performance. These findings improve our understanding of how to promote enduring healthy lifestyles and can inform the design of mHealth strategies for maintaining behavior changes. UR - https://www.jmir.org/2023/1/e42482 UR - http://dx.doi.org/10.2196/42482 UR - http://www.ncbi.nlm.nih.gov/pubmed/37036755 ID - info:doi/10.2196/42482 ER - TY - JOUR AU - Reilly, D. Erin AU - Kathawalla, Ummul-Kiram AU - Robins, E. Hannah AU - Heapy, A. Alicia AU - Hogan, P. Timothy AU - Waring, E. Molly AU - Quigley, S. Karen AU - Drebing, E. Charles AU - Bickmore, Timothy AU - Volonte, Matias AU - Kelly, M. Megan PY - 2023/3/7 TI - An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial JO - JMIR Res Protoc SP - e45887 VL - 12 KW - chronic pain KW - randomized controlled trial KW - usability KW - acceptance and commitment therapy KW - embodied conversational agent N2 - Background: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain?related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. Objective: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). Methods: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. Results: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. Conclusions: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Trial Registration: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): DERR1-10.2196/45887 UR - https://www.researchprotocols.org/2023/1/e45887 UR - http://dx.doi.org/10.2196/45887 UR - http://www.ncbi.nlm.nih.gov/pubmed/36881446 ID - info:doi/10.2196/45887 ER - TY - JOUR AU - Sui, Yufang AU - Kor, Kin Patrick Pui AU - Li, Mengli AU - Wang, Jingjing PY - 2023/2/20 TI - Effects of a Social Media?Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial JO - JMIR Form Res SP - e42861 VL - 7 KW - mind-body intervention KW - acupressure KW - mindfulness meditation KW - social media N2 - Background: Family caregivers of frail older adults experience high levels of stress. Mind-body interventions (MBIs) focused on caregiver stress are often limited in teaching approaches, difficult to practice, and costly. A social media?based MBI embedded with mindfulness meditation (MM) and self-administered acupressure (SA) may be effective for family caregivers, offer greater usability, and lead to greater adherence. Objective: The aim of this study was to test the feasibility and preliminary effects of a social media?based MBI embedded with MM and SA on family caregivers of frail older adults and to investigate the preliminary effects of the intervention using a pilot randomized controlled trial. Methods: A 2-arm randomized controlled trial design was adopted. Family caregivers of frail older adults (n=64) were randomized into either the intervention group (n=32), receiving 8 weeks of social media?based MM and SA, or the control group (n=32), receiving brief education on caregiving for people with frailty. The primary outcome (caregiver stress) and secondary outcomes (caregiver burden, sleep quality, and mindfulness awareness and attention) were measured using a web-based survey at baseline (T0), immediately after the intervention (T1), and at the 3-month follow-up (T2). Results: The feasibility of the intervention was established with a high attendance rate (87.5%), high usability score (79), and low attrition rate (1.6%). The generalized estimating equation results showed that participants in the intervention group at T1 and T2 experienced a significant improvement in stress reduction (P=.02 and P=.04, respectively), sleep quality (P=.004 and P=.01, respectively), and mindful awareness and attention (P=.006 and P=.02, respectively) compared with the control group. There were no substantial improvements in caregiver burden at T1 and T2 (P=.59 and P=.47, respectively). A focus group session conducted after the intervention had 5 themes: impact on the family caregivers, difficulty in practicing the intervention, the strength of the program, the limitations of the program, and perception of the intervention. Conclusions: The findings support the feasibility and preliminary effects of social media?based MBI embedded with acupressure and MM on reducing stress among family caregivers of frail older people and enhancing sleep quality and mindfulness levels. A future study with a larger and more diverse sample is proposed to evaluate the longer-term effects and generalizability of the intervention. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100049507; http://www.chictr.org.cn/showproj.aspx?proj=128031 UR - https://formative.jmir.org/2023/1/e42861 UR - http://dx.doi.org/10.2196/42861 UR - http://www.ncbi.nlm.nih.gov/pubmed/36804167 ID - info:doi/10.2196/42861 ER - TY - JOUR AU - Zhang, Xuan AU - Li, Yang AU - Wang, Juan AU - Mao, Fangxiang AU - Wu, Liuliu AU - Huang, Yongqi AU - Sun, Jiwei AU - Cao, Fenglin PY - 2023/2/10 TI - Effectiveness of Digital Guided Self-help Mindfulness Training During Pregnancy on Maternal Psychological Distress and Infant Neuropsychological Development: Randomized Controlled Trial JO - J Med Internet Res SP - e41298 VL - 25 KW - digital KW - mobile health KW - mHealth KW - guided self-help KW - psychological distress KW - pregnancy KW - psychosocial intervention KW - mindfulness KW - infant KW - neuropsychological performance N2 - Background: Maternal psychological distress during pregnancy is associated with unfavorable outcomes in infants. Mindfulness-based interventions (MBIs) can effectively alleviate psychological distress, but there are often barriers to the access of face-to-face interventions. Objective: This study aimed to investigate the effectiveness of a digital guided self-help (GSH) MBI (GSH-MBI) in reducing maternal psychological distress and improving infant neuropsychological performance. Methods: This was a randomized controlled trial. We recruited 160 women who were 12 to 20 weeks pregnant and exhibited psychological distress. We randomized them into a digital GSH-MBI group and a control group (usual perinatal care). The digital GSH-MBI consisted of a 6-week intervention through a WeChat mini program, with a daily reminder sent to the participants by a research assistant via WeChat. The primary outcomes consisted of maternal psychological distress, including depression, anxiety, and pregnancy-related anxiety symptoms, which were assessed at 6 time points from baseline to 6 months post partum (only pregnancy-related anxiety symptoms were assessed 3 times during pregnancy). The secondary outcomes were infant neuropsychological outcomes, including temperament and developmental behaviors, which were assessed at 6 weeks and 6 months post partum. Results: Compared with the control group, the digital GSH-MBI group showed a significant reduction in depression, anxiety, and pregnancy-related anxiety symptoms. In addition, the scores of the digital GSH-MBI group were lower than those of the control group for the 3 types of infant temperament at 6 weeks post partum, including quality of mood, distractibility, and adaptability. Conclusions: Digital GSH-MBIs are effective in alleviating psychological distress among pregnant women and protecting infant outcomes. Trial Registration: Chinese Clinical Trial Register ChiCTR2000040717; https://www.chictr.org.cn/showproj.aspx?proj=65376 UR - https://www.jmir.org/2023/1/e41298 UR - http://dx.doi.org/10.2196/41298 UR - http://www.ncbi.nlm.nih.gov/pubmed/36763452 ID - info:doi/10.2196/41298 ER - TY - JOUR AU - Lynn, Sarah AU - Basso, C. Julia PY - 2023/1/19 TI - Effects of a Neuroscience-Based Mindfulness Meditation Program on Psychological Health: Pilot Randomized Controlled Trial JO - JMIR Form Res SP - e40135 VL - 7 KW - meditation KW - mindfulness KW - mental health KW - compassion KW - self-compassion KW - digital KW - medical education KW - neuroscience education KW - depression KW - psychological health KW - mental illness KW - anxiety N2 - Background: Mindfulness and meditation have a rich historical tradition, and a growing scientific base of evidence supports their use in creating positive psychological and neuroplastic changes for practitioners. Although meditation can be taught in various ways, the scientific community has yet to systematically study the impact of different types of meditation on neuropsychological outcomes, especially as it pertains to digital implementation. Therefore, it is critical that the instruction of mindfulness be evidence based because meditation is being used in both scientific and clinical settings. Objective: This study investigated the use of teacher cueing and the integration of neuroscience education into a meditation program. Compassion cueing was chosen as the element of experimental manipulation because traditional lineages of Buddhist meditation teach compassion for self and others as one of the primary outcomes of meditation. We hypothesized that participants receiving compassion cueing would have enhanced neuropsychological outcomes compared with those receiving functional cueing and that gains in neuroscience knowledge would relate to positive neuropsychological outcomes. Methods: Participants (n=89) were randomized to receive either functional cueing (control group) or compassion cueing (experimental group) and engaged with five 10-minute meditation sessions a week for 4 weeks. All intervention sessions were administered through digital presentation. All participants completed ecological momentary assessments before and after the daily intervention, as well as pre- and postintervention questionnaires. Results: Participants demonstrated significant benefits over time, including increased mindfulness and self-compassion, decreased depression, and gains in neuroscience content (all P<.001); however, no significant between-group differences were found. Daily scores from each day of the intervention showed a statistically significant shift from active toward settled. Importantly, long-term increases in mindfulness were positively correlated to changes in compassion (r=0.326; P=.009) and self-compassion (r=0.424; P<.001) and negatively correlated to changes in anxiety (r=?0.266; P=.03) and depression (r=?0.271; P=.03). Finally, the acute effects of meditation were significantly correlated to the longitudinal outcomes (with a small-to-medium effect size), especially those relevant to mindfulness. Conclusions: We developed a novel neuroscience-based education?meditation program that enhanced self-regulation as evidenced by improved mindfulness, self-compassion, and mood state. Our findings demonstrate the behavioral importance of engaging with mindfulness meditation and reinforce the idea that the benefits of meditation are independent of teacher cueing behavior. Future studies will need to investigate the brain-based changes underlying these meditation-induced outcomes. UR - https://formative.jmir.org/2023/1/e40135 UR - http://dx.doi.org/10.2196/40135 UR - http://www.ncbi.nlm.nih.gov/pubmed/36656631 ID - info:doi/10.2196/40135 ER - TY - JOUR AU - Chen, Bin AU - Yang, Ting AU - Xiao, Lei AU - Xu, Changxia AU - Zhu, Chunqin PY - 2023/1/3 TI - Effects of Mobile Mindfulness Meditation on the Mental Health of University Students: Systematic Review and Meta-analysis JO - J Med Internet Res SP - e39128 VL - 25 KW - digital health KW - mobile mindfulness meditation KW - mental health KW - university students KW - meta-analysis N2 - Background: Mobile mindfulness meditation (MMM) is a mindfulness meditation intervention implemented using mobile devices such as smartphones and apps. MMM has been used to help manage the mental health of university students. Objective: This study aims to evaluate the effectiveness of MMM on the mental health of university students in the areas of stress, anxiety, depression, mindfulness, well-being, and resilience. Methods: We conducted a systematic review and meta-analysis of the effectiveness of MMM on the mental health of university students. This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. An electronic literature search was performed on PubMed, Web of Science, EBSCO, Cochrane Library, and Embase databases, from inception to July 16, 2021. This study was conducted to identify studies that reported the effects of MMM on the primary outcomes including stress, anxiety, and depression, and on the secondary outcomes including mindfulness, well-being, and resilience. Two reviewers retrieved articles, evaluated quality, and extracted data independently. The methodological quality of the selected studies was determined using the Cochrane criteria for risk-of-bias assessment. Standardized mean differences (SMDs) for continuous outcomes and risk ratios for dichotomous outcomes were calculated. Sensitivity analyses and subgroup analyses were performed for results with high heterogeneity. The RevMan version 5.3 was used to perform meta-analysis. Results: A total of 10 studies, including 958 university students, were selected for this meta-analysis. Results of the primary outcome showed that the MMM groups were more effective than the control groups in decreasing stress (SMD ?0.41, 95% CI ?0.59 to ?0.23; P<.001) and alleviating anxiety (SMD ?0.29, 95% CI ?0.50 to ?0.09; P=.004). However, there was no difference between the MMM groups and the control groups in depression (SMD ?0.14, 95% CI ?0.30 to 0.03; P=.11). The use of either waitlist control or traditional face-to-face intervention in the control group was identified as the source of heterogeneity. Specifically, the waitlist control subgroup (SMD ?0.33, 95% CI ?0.53 to ?0.13; P=.002) was superior when compared with the face-to-face subgroup (SMD 0.29, 95% CI ?0.01 to 0.59; P=.06). Results of the secondary outcome showed that the MMM groups were more effective than the control groups in enhancing well-being (SMD 0.30, 95% CI 0.11-0.50; P=.003) and improving mindfulness (SMD 2.66, 95% CI 0.77-4.55; P=.006). Whether commercial sponsorship was obtained was considered as the source of heterogeneity. The ?without company support? group (SMD 17.60, 95% CI 11.32-23.87; P<.001) was superior to the ?with company support? group (SMD 1.17, 95% CI ?0.82 to 3.15; P=.25) in raising the level of mindfulness. However, there was no difference between the MMM and control groups in resilience (SMD ?0.06, 95% CI ?0.26 to 0.15; P=.59). The evidence level of the results from the 10 studies was determined to be moderate to low. Conclusions: MMM was an effective method to reduce stress and anxiety, and to increase the well-being and mindfulness of university students. However, further studies are needed to confirm our findings. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022303585; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=303585 UR - https://www.jmir.org/2023/1/e39128 UR - http://dx.doi.org/10.2196/39128 UR - http://www.ncbi.nlm.nih.gov/pubmed/36596239 ID - info:doi/10.2196/39128 ER - TY - JOUR AU - Anderson, A. Molly AU - Budney, J. Alan AU - Jacobson, C. Nicholas AU - Nahum-Shani, Inbal AU - Stanger, Catherine PY - 2022/12/15 TI - End User Participation in the Development of an Ecological Momentary Intervention to Improve Coping With Cannabis Cravings: Formative Study JO - JMIR Form Res SP - e40139 VL - 6 IS - 12 KW - cannabis KW - formative KW - distraction KW - mindfulness KW - coping KW - youth KW - public health KW - mental health KW - health intervention KW - ecological momentary intervention N2 - Background: Cannabis misuse in young adults is a major public health concern. An important predictor of continued use is cannabis craving. Due to the time-varying nature of cravings, brief momentary interventions delivered while cravings are elevated may improve the use of strategies to cope with cravings and reduce cannabis use. Objective: The goal of this manuscript is to describe a formative study to develop coping strategy messages for use in a subsequent intervention. Methods: Young adults (aged 19-25 years; n=20) who reported using cannabis >10 of the past 30 days recruited via social media participated in this formative study. Participants rated an initial set of 15 mindfulness and 15 distraction coping strategies on a scale from 1 to 4 (very low degree to very high degree) for clarity, usefulness, and tone. They also provided comments about the content. Results: Participants found the initial distraction messages slightly clearer than mindfulness (mean 3.5, SD 0.4 and mean 3.4, SD 0.4, respectively), both were comparable in tone (mean 3.2, SD 0.5 and mean 3.2, SD 0.4, respectively), and mindfulness messages were more useful than distraction (mean 3.0, SD 0.5 and mean 2.8, SD 0.6, respectively). Of the 30 messages, 29 received a rating of very low or low (<2) on any domain by >3 participants or received a comment suggesting a change. We revised all these messages based on this feedback, and the participants rated the revised messages approximately 2 weeks later. Participants earned US $10 for completing the first and US $20 for the second survey. The ratings improved on usefulness (especially the distraction items) with very little change in clarity and tone. The top 10 messages of each coping type (mindfulness and distraction) were identified by overall average rating (collapsed across all 3 dimensions: all rated >3.0). The final items were comparable in clarity (distraction mean 3.6, SD 0.4; mindfulness mean 3.6, SD 0.4), tone (distraction mean 3.4, SD 0.4; mindfulness mean 3.4, SD 0.4), and usefulness (distraction mean 3.1, SD 0.5; mindfulness mean 3.2, SD 0.5). Conclusions: The inclusion of end users in the formative process of developing these messages was valuable and resulted in improvements to the content of the messages. The majority of the messages were changed in some way including the removal of potentially triggering language. These messages were subsequently used in an ecological momentary intervention. UR - https://formative.jmir.org/2022/12/e40139 UR - http://dx.doi.org/10.2196/40139 UR - http://www.ncbi.nlm.nih.gov/pubmed/36520509 ID - info:doi/10.2196/40139 ER - TY - JOUR AU - Seah, L. Cassandra E. AU - Zhang, Zheyuan AU - Sun, Sijin AU - Wiskerke, Esther AU - Daniels, Sarah AU - Porat, Talya AU - Calvo, A. Rafael PY - 2022/12/6 TI - Designing Mindfulness Conversational Agents for People With Early-Stage Dementia and Their Caregivers: Thematic Analysis of Expert and User Perspectives JO - JMIR Aging SP - e40360 VL - 5 IS - 4 KW - mindfulness KW - dyadic KW - dementia KW - caregivers KW - user needs KW - intervention KW - user KW - feedback KW - design KW - accessibility KW - relationships KW - mindset KW - essential N2 - Background: The number of people with dementia is expected to grow worldwide. Among the ways to support both persons with early-stage dementia and their caregivers (dyads), researchers are studying mindfulness interventions. However, few studies have explored technology-enhanced mindfulness interventions for dyads and the needs of persons with dementia and their caregivers. Objective: The main aim of this study was to elicit essential needs from people with dementia, their caregivers, dementia experts, and mindfulness experts to identify themes that can be used in the design of mindfulness conversational agents for dyads. Methods: Semistructured interviews were conducted with 5 dementia experts, 5 mindfulness experts, 5 people with early-stage dementia, and 5 dementia caregivers. Interviews were transcribed and coded on NVivo (QSR International) before themes were identified through a bottom-up inductive approach. Results: The results revealed that dyadic mindfulness is preferred and that implementation formats such as conversational agents have potential. A total of 5 common themes were also identified from expert and user feedback, which should be used to design mindfulness conversational agents for persons with dementia and their caregivers. The 5 themes included enhancing accessibility, cultivating positivity, providing simplified tangible and thought-based activities, encouraging a mindful mindset shift, and enhancing relationships. Conclusions: In essence, this research concluded with 5 themes that mindfulness conversational agents could be designed based on to meet the needs of persons with dementia and their caregivers. UR - https://aging.jmir.org/2022/4/e40360 UR - http://dx.doi.org/10.2196/40360 UR - http://www.ncbi.nlm.nih.gov/pubmed/36472897 ID - info:doi/10.2196/40360 ER - TY - JOUR AU - Kim, Sunghak AU - Park, Young Jin AU - Chung, Kyungmi PY - 2022/11/30 TI - The Relationship Between the Big Five Personality Traits and the Theory of Planned Behavior in Using Mindfulness Mobile Apps: Cross-sectional Survey JO - J Med Internet Res SP - e39501 VL - 24 IS - 11 KW - personality traits KW - Theory of Planned Behavior KW - mindfulness KW - mobile apps KW - mental health N2 - Background: Mindfulness has emerged as a promising approach toward improving mental health. Interest in mindfulness mobile app services has also increased in recent years. Understanding the determinants of mindfulness behavior is essential to predict people?s utilization of mindfulness mobile apps and beneficial for developing and implementing relevant intervention strategies. Nevertheless, little has been done to determine the predictors of mindfulness behavior. Objective: This study investigates the association between the Big Five personality traits and the Theory of Planned Behavior (TPB) variables in the context of using mindfulness mobile apps to explore the potential indirect effects of conscientiousness and neuroticism on people?s behavioral intention for mindfulness, mediated by their attitude toward mindfulness, subjective norm about mindfulness, and perceived behavior control over mindfulness. Methods: The authors conducted an online, cross-sectional survey in December 2021. Structural equation modeling was conducted to evaluate the overall model fit and test possible linkages among conscientiousness, neuroticism, attitude toward mindfulness, subjective norm about mindfulness, perceived behavior control over mindfulness, and behavioral intention for mindfulness. Bootstrapping mediation analyses were also conducted to test the potential mediating effect in the model. Results: A total of 297 Korean participants? responses (153 males and 144 females) were analyzed. The proposed model had a good fit. Conscientiousness was correlated with attitude toward mindfulness (?=.384, P<.001), subjective norm about mindfulness (?=.249, P<.001), and perceived behavior control over mindfulness (?=.443, P<.001). Neuroticism was not correlated with attitude toward mindfulness (?=?.072, P=.28), but was correlated with subjective norm about mindfulness (?=.217, P=.003) and perceived behavior control over mindfulness (?=?.235, P<.001). Attitude toward mindfulness (?=.508, P<.001), subjective norm about mindfulness (?=.132, P=.01), and perceived behavior control over mindfulness (?=.540, P<.001) were separately correlated with behavioral intention for mindfulness. Conscientiousness was not directly correlated with behavioral intention for mindfulness (?=?.082, P=.27), whereas neuroticism was directly correlated with behavioral intention for mindfulness (?=.194, P=.001). Conscientiousness was indirectly linked with behavioral intention for mindfulness through attitude toward mindfulness (B=0.171, 95% CI 0.103-0.251) and perceived behavior control over mindfulness (B=0.198, 95% CI 0.132-0.273) but not through subjective norm about mindfulness (B=0.023, 95% CI ?0.002 to 0.060). Neuroticism was indirectly linked with behavioral intention for mindfulness via perceived behavior control over mindfulness (B=?0.138, 95% CI ?0.197 to ?0.088) but not via subjective norm about mindfulness (B=0.021, 95% CI ?0.002 to 0.059). Conclusions: The results show that the integration of the Big Five personality traits and TPB constructs is useful in predicting the use of mindfulness mobile apps. Focusing on conscientiousness and neuroticism in developing information dissemination and implementation strategies for enhancing mindfulness behavior using mobile apps may lead to the successful promotion of mindfulness mobile apps and adherence to mindfulness techniques. UR - https://www.jmir.org/2022/11/e39501 UR - http://dx.doi.org/10.2196/39501 UR - http://www.ncbi.nlm.nih.gov/pubmed/36449344 ID - info:doi/10.2196/39501 ER - TY - JOUR AU - Wang, Luyao AU - Chen, Xing AU - Peng, Yueyang AU - Zhang, Kun AU - Ma, Jun AU - Xu, Lin AU - Liu, Zixuan AU - Liu, Li AU - Luo, Yang AU - Gu, Can PY - 2022/11/22 TI - Effect of a 4-Week Internet-Delivered Mindfulness-Based Cancer Recovery Intervention on the Symptom Burden and Quality of Life of Patients With Breast Cancer: Randomized Controlled Trial JO - J Med Internet Res SP - e40059 VL - 24 IS - 11 KW - mindfulness-based cancer recovery KW - mindfulness-based intervention KW - cancer-related symptom KW - quality of life KW - breast cancer KW - internet-delivered intervention KW - mobile phone N2 - Background: Mindfulness-based interventions (MBIs) can improve the symptoms and psychological well-being of patients with breast cancer. However, standard MBIs are an 8-week program delivered face-to-face, which may be inconvenient for patients with cancer. Many attempts have been made to adapt MBIs to increase their accessibility for patients with cancer while maintaining their therapeutic components and efficacy. Objective: This study aimed to investigate the effectiveness of a 4-week internet-delivered mindfulness-based cancer recovery (iMBCR) program in reducing symptom burden and enhancing the health-related quality of life (HRQoL) of patients with breast cancer. Methods: A total of 103 postoperative patients with breast cancer (stages 0 to IV) were randomly assigned to an iMBCR group (4-week iMBCR; n=51, 49.5%) or a control group (usual care and 4-week program of health education information; n=52, 50.5%). The study outcomes included symptom burden and HRQoL, as measured by the MD Anderson Symptom Inventory and the Functional Assessment of Cancer Therapy-Breast scale. All data were collected at baseline (T0), after the intervention (T1), and at 1-month follow-up (T2). Data analysis followed the intention-to-treat principle. Linear mixed models were used to assess the effects over time of the iMBCR program. Results: Participants in the iMBCR group had significantly larger decreases in symptom burden than those in the control group at T1 (mean difference ?11.67, 95% CI ?16.99 to ?6.36), and the decreases were maintained at T2 (mean difference ?11.83, 95% CI ?18.19 to ?5.46). The HRQoL score in the iMBCR group had significantly larger improvements than that in the control group at T1 and T2 (mean difference 6.66, 95% CI 3.43-9.90 and mean difference 11.94, 95% CI 7.56-16.32, respectively). Conclusions: Our preliminary findings suggest that the iMBCR program effectively improved the symptom burden and HRQoL of patients with breast cancer, and the participants in the iMBCR group demonstrated good adherence and completion rates. These results indicate that the iMBCR intervention might be a promising way to reduce symptom burden and improve HRQoL of patients with cancer. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000038980; http://www.chictr.org.cn/showproj.aspx?proj=62659 UR - https://www.jmir.org/2022/11/e40059 UR - http://dx.doi.org/10.2196/40059 UR - http://www.ncbi.nlm.nih.gov/pubmed/36413385 ID - info:doi/10.2196/40059 ER - TY - JOUR AU - Yadav, Muskan AU - Neate, Sandra AU - Hassed, Craig AU - Chambers, Richard AU - Connaughton, Sherelle AU - Nag, Nupur PY - 2022/10/5 TI - Mining the Gems of a Web-Based Mindfulness Intervention: Qualitative Analysis of Factors Aiding Completion and Implementation JO - JMIR Form Res SP - e37406 VL - 6 IS - 10 KW - digital intervention KW - health education KW - mindfulness KW - online learning KW - behavior change KW - mental health KW - mental well-being KW - physical well-being KW - meditation KW - health promotion KW - digital health KW - eHealth KW - thematic analysis KW - attrition KW - participation KW - involvement KW - engagement KW - attitude KW - perspective KW - patient education KW - e-learning KW - user feedback N2 - Background: Digital health interventions provide a cost effective and accessible means for positive behavior change. However, high participant attrition is common and facilitators for implementation of behaviors are not well understood. Objective: The goal of the research was to identify elements of a digital mindfulness course that aided in course completion and implementation of teachings. Methods: Inductive thematic analysis was used to assess participant comments regarding positive aspects of the online mindfulness course Mindfulness for Well-being and Peak Performance. Participants were aged 18 years and older who had self-selected to register and voluntarily completed at least 90% the course. The course comprised educator-guided lessons and discussion forums for participant reflection and feedback. Participant comments from the final discussion forum were analyzed to identify common themes pertaining to elements of the course that aided in course completion and implementation of teachings. Results: Of 3355 course completers, 283 participants provided comments related to the research question. Key themes were (1) benefits from the virtual community, (2) appeal of content, (3) enablers to participation and implementation, and (4) benefits noted in oneself. Of subthemes identified, some, such as community support, variety of easily implementable content, and free content access, align with that reported previously in the literature, while other subthemes, including growing together, repeating the course, evidence-based teaching, and immediate benefits on physical and mental well-being, were novel findings. Conclusions: Themes identified as key elements for aiding participant completion of a mindfulness digital health intervention and the implementation of teachings may inform the effective design of future digital health interventions to drive positive health behaviors. Future research should focus on understanding motivations for participation, identification of effective methods for participant retention, and behavior change techniques to motivate long-term adherence to healthy behaviors. UR - https://formative.jmir.org/2022/10/e37406 UR - http://dx.doi.org/10.2196/37406 UR - http://www.ncbi.nlm.nih.gov/pubmed/36197709 ID - info:doi/10.2196/37406 ER - TY - JOUR AU - Espel-Huynh, Hallie AU - Baldwin, Matthew AU - Puzia, Megan AU - Huberty, Jennifer PY - 2022/9/28 TI - The Indirect Effects of a Mindfulness Mobile App on Productivity Through Changes in Sleep Among Retail Employees: Secondary Analysis JO - JMIR Mhealth Uhealth SP - e40500 VL - 10 IS - 9 KW - mindfulness KW - mobile apps KW - workforce KW - workplace KW - sleep KW - presenteeism KW - mobile phone N2 - Background: Chronic sleep disturbance is prevalent among United States employees and associated with costly productivity impairment. Mindfulness interventions improve sleep (ie, insomnia and daytime sleepiness) and productivity outcomes, and mobile apps provide scalable means of intervention delivery. However, few studies have examined the effects of mindfulness mobile apps on employees, and no research to date has tested the role of sleep improvement as a potential mechanism of action for productivity outcomes. Objective: This study examined the effects of Calm, a consumer-based mindfulness app, and sleep coaching, on productivity impairment among retail employees through the indirect effects of changes in insomnia and daytime sleepiness. Methods: This study was a secondary analysis of data from a randomized controlled trial (N=1029) comparing the use of Calm (n=585, 56.9%) to a waitlist control (n=444, 43.2%) for 8 weeks among employees of a large retail employer in the United States. A subset of individuals with elevated insomnia symptoms also had access to brief sleep coaching with Calm (n=101, 9.8%). Insomnia symptom severity, daytime sleepiness, and productivity impairment (ie, absenteeism, presenteeism, overall productivity impairment, and non?work activity impairment) were assessed at baseline and weeks 2, 4, 6, and 8. Indirect effects were evaluated with latent growth curve modeling to test whether the Calm intervention (Calm group vs waitlist control) was effective in reducing work productivity impairment through changes in sleep disturbance. Results: No significant main effects of Calm intervention on productivity impairment were detected for any outcome at ? level of .05, with the exception of non?work activity impairment models, in which Calm intervention reduced non?work activity impairment over time (P=.01 and P=.02 for insomnia and sleepiness models, respectively). Significant indirect effects of insomnia were detected for presenteeism (P=.002), overall work productivity (P=.01), and non?work activity impairment (P=.002); Calm intervention produced significantly greater reductions in insomnia symptoms (relative to waitlist control), and decreases in insomnia were associated with decreases in work productivity impairment. There was no significant indirect effect of change in insomnia on changes in absenteeism (P=.20). Furthermore, we detected no significant indirect effects of daytime sleepiness on productivity impairment. Conclusions: We found that Calm (plus sleep coaching for a small subset of individuals) had beneficial effects on employee sleep, and these benefits on sleep were related to indirect effects on productivity impairment (ie, presenteeism, overall work productivity impairment, and non?work activity impairment). There were no overall main effects of Calm intervention on productivity impairment; however, insomnia appears to be a mechanism associated with benefits for employee productivity. This is one of the first studies to suggest that sleep benefits of a mindfulness mobile app may also indirectly relate to benefits for workplace productivity. Trial Registration: ClinicalTrials.gov NCT05120310; https://clinicaltrials.gov/ct2/show/NCT05120310 UR - https://mhealth.jmir.org/2022/9/e40500 UR - http://dx.doi.org/10.2196/40500 UR - http://www.ncbi.nlm.nih.gov/pubmed/36169994 ID - info:doi/10.2196/40500 ER - TY - JOUR AU - Huberty, L. Jennifer AU - Espel-Huynh, M. Hallie AU - Neher, L. Taylor AU - Puzia, E. Megan PY - 2022/9/28 TI - Testing the Pragmatic Effectiveness of a Consumer-Based Mindfulness Mobile App in the Workplace: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e38903 VL - 10 IS - 9 KW - mindfulness KW - mobile apps KW - workforce KW - workplace KW - presenteeism KW - mental health N2 - Background: Mental health and sleep problems are prevalent in the workforce, corresponding to costly impairment in productivity and increased health care use. Digital mindfulness interventions are efficacious in improving sleep and mental health in the workplace; however, evidence supporting their pragmatic utility, potential for improving productivity, and ability to reduce employer costs is limited. Objective: This pragmatic, cluster randomized controlled trial aimed to evaluate the experimental effects of implementing a commercially available mindfulness app?Calm?in employees of a large, multisite employer in the United States. Outcomes included mental health (depression, anxiety, and stress), sleep (insomnia and daytime sleepiness), resilience, productivity impairment (absenteeism, presenteeism, overall work impairment, and non?work activity impairment), and health care use (medical visit frequency). Methods: Employees were randomized at the work site to receive either the Calm app intervention or waitlist control. Participants in the Calm intervention group were instructed to use the Calm app for 10 minutes per day for 8 weeks; individuals with elevated baseline insomnia symptoms could opt-in to 6 weeks of sleep coaching. All outcomes were assessed every 2 weeks, with the exception of medical visits (weeks 4 and 8 only). Effects of the Calm intervention on outcomes were evaluated via mixed effects modeling, controlling for relevant baseline characteristics, with fixed effects of the intervention on outcomes assessed at weeks 2, 4, 6, and 8. Models were analyzed via complete-case and intent-to-treat analyses. Results: A total of 1029 employees enrolled (n=585 in the Calm intervention group, including 101 who opted-in to sleep coaching, and n=444 in waitlist control). Of them, 192 (n=88 for the Calm intervention group and n=104 for waitlist) completed all 5 assessments. In the complete-case analysis at week 8, employees at sites randomized to the Calm intervention group experienced significant improvements in depression (P=.02), anxiety (P=.01), stress (P<.001), insomnia (P<.001), sleepiness (P<.001), resilience (P=.02), presenteeism (P=.01), overall work impairment (P=.004), and nonwork impairment (P<.001), and reduced medical care visit frequency (P<.001) and productivity impairment costs (P=.01), relative to the waitlist control. In the intent-to-treat analysis at week 8, significant benefits of the intervention were observed for depression (P=.046), anxiety (P=.01), insomnia (P<.001), sleepiness (P<.001), nonwork impairment (P=.04), and medical visit frequency (P<.001). Conclusions: The results suggest that the Calm app is an effective workplace intervention for improving mental health, sleep, resilience, and productivity and for reducing medical visits and costs owing to work impairment. Future studies should identify optimal implementation strategies that maximize employee uptake and large-scale implementation success across diverse, geographically dispersed employers. Trial Registration: ClinicalTrials.gov NCT05120310; https://clinicaltrials.gov/ct2/show/NCT05120310 UR - https://mhealth.jmir.org/2022/9/e38903 UR - http://dx.doi.org/10.2196/38903 UR - http://www.ncbi.nlm.nih.gov/pubmed/36169991 ID - info:doi/10.2196/38903 ER - TY - JOUR AU - Mackey, Sean AU - Gilam, Gadi AU - Darnall, Beth AU - Goldin, Philippe AU - Kong, Jiang-Ti AU - Law, Christine AU - Heirich, Marissa AU - Karayannis, Nicholas AU - Kao, Ming-Chih AU - Tian, Lu AU - Manber, Rachel AU - Gross, James PY - 2022/9/27 TI - Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials JO - JMIR Res Protoc SP - e37823 VL - 11 IS - 9 KW - mind-body therapies KW - chronic low back pain KW - nonpharmacologic treatments KW - neuroimaging N2 - Background: Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated. Objective: In response to these knowledge gaps, the Stanford Center for Low Back Pain?a collaborative, National Institutes of Health P01?funded, multidisciplinary research center?was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments. Methods: The multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy. Results: Participant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021. Conclusions: This center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments. Trial Registration: ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475 International Registered Report Identifier (IRRID): PRR1-10.2196/37823 UR - https://www.researchprotocols.org/2022/9/e37823 UR - http://dx.doi.org/10.2196/37823 UR - http://www.ncbi.nlm.nih.gov/pubmed/36166279 ID - info:doi/10.2196/37823 ER - TY - JOUR AU - Sylvia, G. Louisa AU - Lunn, R. Mitchell AU - Obedin-Maliver, Juno AU - McBurney, N. Robert AU - Nowell, Benjamin W. AU - Nosheny, L. Rachel AU - Mularski, A. Richard AU - Long, D. Millie AU - Merkel, A. Peter AU - Pletcher, J. Mark AU - Tovey, E. Roberta AU - Scalchunes, Christopher AU - Sutphen, Rebecca AU - Martin, S. Ann AU - Horn, J. Elizabeth AU - O'Boyle, Megan AU - Pitch, Lisa AU - Seid, Michael AU - Redline, Susan AU - Greenebaum, Sophie AU - George, Nevita AU - French, J. Noah AU - Faria, M. Caylin AU - Puvanich, Nicha AU - Rabideau, J. Dustin AU - Selvaggi, A. Caitlin AU - Yu, Chu AU - Faraone, V. Stephen AU - Venkatachalam, Shilpa AU - McCall, Debbe AU - Terry, F. Sharon AU - Deckersbach, Thilo AU - Nierenberg, A. Andrew PY - 2022/9/12 TI - Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial JO - J Med Internet Res SP - e35620 VL - 24 IS - 9 KW - mindfulness KW - well-being KW - web KW - control trial KW - clinical trial KW - cognitive therapy KW - intervention KW - mental health KW - mindful KW - eHealth KW - mobile phone N2 - Background: Mindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being. Objective: The primary aim of this study was to determine whether a standard 8-session web-based mindfulness-based cognitive therapy (MBCT) program, compared with a brief 3-session mindfulness intervention, improved overall participant well-being. In addition, we sought to explore whether the treatment effects differed based on the baseline characteristics of the participants (ie, moderators). Methods: Participants were recruited from 17 patient-powered research networks, web-based communities of stakeholders interested in a common research area. Participants were randomized to either a standard 8-session MBCT or a brief 3-session mindfulness training intervention accessed on the web. The participants were followed for 12 weeks. The primary outcome of the study was well-being, as measured by the World Health Organization?Five Well-Being Index. We hypothesized that MBCT would be superior to a brief mindfulness training. Results: We randomized 4411 participants, 3873 (87.80%) of whom were White and 3547 (80.41%) of female sex assigned at birth. The mean baseline World Health Organization?Five Well-Being Index score was 50.3 (SD 20.7). The average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks; model-based slope for the MBCT group: 0.78, 95% CI 0.63-0.93, and brief mindfulness group: 0.76, 95% CI 0.60-0.91) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks; model-based slope for MBCT group: 0.41, 95% CI 0.34-0.48; and brief mindfulness group: 0.33, 95% CI 0.26-0.40). Changes in self-reported well-being were not significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes: ?0.02, 95% CI ?0.24 to 0.19; P=.80) or during the intervention period plus 12-week follow-up (?0.08, 95% CI ?0.18 to 0.02; P=.10). During the intervention period, younger participants (P=.05) and participants who completed a higher percentage of intervention sessions (P=.005) experienced greater improvements in well-being across both interventions, with effects that were stronger for participants in the MBCT condition. Attrition was high (ie, 2142/4411, 48.56%), which is an important limitation of this study. Conclusions: Standard MBCT improved well-being but was not superior to a brief mindfulness intervention. This finding suggests that shorter mindfulness programs could yield important benefits across the general population of individuals with various medical conditions. Younger people and participants who completed more intervention sessions reported greater improvements in well-being, an effect that was more pronounced for participants in the MBCT condition. This finding suggests that standard MBCT may be a better choice for younger people as well as treatment-adherent individuals. Trial Registration: ClinicalTrials.gov NCT03844321; https://clinicaltrials.gov/ct2/show/NCT03844321 UR - https://www.jmir.org/2022/9/e35620 UR - http://dx.doi.org/10.2196/35620 UR - http://www.ncbi.nlm.nih.gov/pubmed/36094813 ID - info:doi/10.2196/35620 ER - TY - JOUR AU - Taylor, Heather AU - Cavanagh, Kate AU - Field, P. Andy AU - Strauss, Clara PY - 2022/8/25 TI - Health Care Workers? Need for Headspace: Findings From a Multisite Definitive Randomized Controlled Trial of an Unguided Digital Mindfulness-Based Self-help App to Reduce Healthcare Worker Stress JO - JMIR Mhealth Uhealth SP - e31744 VL - 10 IS - 8 KW - self-help KW - mindfulness KW - randomized control trial KW - health care worker KW - National Health Service KW - NHS KW - doctors KW - nurses KW - stress KW - mental health KW - burnout KW - mobile phone N2 - Background: Health care workers experience high stress. Accessible, affordable, and effective approaches to reducing stress are lacking. In-person mindfulness-based interventions can reduce health care worker stress but are not widely available or accessible to busy health care workers. Unguided, digital, mindfulness-based self-help (MBSH) interventions show promise and can be flexibly engaged with. However, their effectiveness in reducing health care worker stress has not yet been explored in a definitive trial. Objective: This study aimed to investigate the effectiveness of an unguided digital MBSH app (Headspace) in reducing health care worker stress. Methods: This was a definitive superiority randomized controlled trial with 2182 National Health Service staff in England recruited on the web and allocated in a 1:1 ratio to fully automated Headspace (n=1095, 50.18%) or active control (Moodzone; n=1087, 49.82%) for 4.5 months. Outcomes were subscales of the Depression, Anxiety, and Stress (primary outcome) Scale short form; Short Warwick Edinburgh Mental Well-being Scale; Maslach Burnout Inventory; 15-item Five-Facet Mindfulness Questionnaire minus Observe items; Self-Compassion Scale?Short Form; Compassionate Love Scale; Penn State Worry Questionnaire; Brooding subscale of the Ruminative Response Scale; and sickness absence. Results: Intention-to-treat analyses found that Headspace led to greater reductions in stress over time than Moodzone (b=?0.31, 95% CI ?0.47 to ?0.14; P<.001), with small effects. Small effects of Headspace versus Moodzone were found for depression (b=?0.24, 95% CI ?0.40 to ?0.08; P=.003), anxiety (b=?0.19, 95% CI ?0.32 to ?0.06; P=.004), well-being (b=0.14, 95% CI 0.05-0.23; P=.002), mindfulness (b=0.22, 95% CI 0.09-0.34; P=.001), self-compassion (b=0.48, 95% CI 0.33-0.64; P<.001), compassion for others (b=0.02, 95% CI 0.00-0.04; P=.04), and worry (b=?0.30, 95% CI ?0.51 to ?0.09; P=.005) but not for burnout (b=?0.19, ?0.04, and 0.13, all 95% CIs >0; P=.65, .67, and .35), ruminative brooding (b=?0.06, 95% CI ?0.12 to 0.00; P=.06), or sickness absence (?=0.09, 95% CI ?0.18 to 0.34). Per-protocol effects of Headspace (454/1095, 41.46%) versus Moodzone (283/1087, 26.03%) over time were found for stress, self-compassion, and compassion for others but not for the other outcomes. Engagement (practice days per week) and improvements in self-compassion during the initial 1.5-month intervention period mediated pre- to postintervention improvements in stress. Improvements in mindfulness, rumination, and worry did not mediate pre- to postintervention improvements in stress. No serious adverse events were reported. Conclusions: An unguided digital MBSH intervention (Headspace) can reduce health care workers? stress. Effect sizes were small but could have population-level benefits. Unguided digital MBSH interventions can be part of the solution to reducing health care worker stress alongside potentially costlier but potentially more effective in-person mindfulness-based interventions, nonmindfulness courses, and organizational-level interventions. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN15424185; https://tinyurl.com/rv9en5kc UR - https://mhealth.jmir.org/2022/8/e31744 UR - http://dx.doi.org/10.2196/31744 UR - http://www.ncbi.nlm.nih.gov/pubmed/36006668 ID - info:doi/10.2196/31744 ER - TY - JOUR AU - Schönfeld, Simone AU - Rathmer, Ines AU - Michaelsen, M. Maren AU - Hoetger, Cosima AU - Onescheit, Miriam AU - Lange, Silke AU - Werdecker, Lena AU - Esch, Tobias PY - 2022/8/2 TI - Effects of a Mindfulness Intervention Comprising an App, Web-Based Workshops, and a Workbook on Perceived Stress Among Nurses and Nursing Trainees: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e37195 VL - 11 IS - 8 KW - nurses KW - nursing trainee KW - nursing student KW - acute care KW - inpatient KW - health promotion KW - mindfulness KW - mobile KW - web-based KW - stress KW - mobile phone N2 - Background: Previous research has found digitally supported mindfulness interventions to be effective when used for stress management among workers in high-stress occupations. Findings on digitally supported mindfulness interventions among nurses working in acute inpatient care settings are heterogeneous, lack long-term follow-up, and do not assess adherence and acceptability. Objective: This study aimed to investigate the effectiveness and efficacy of a digitally supported mindfulness intervention designed to improve health- and work-related outcomes among nurses and nursing trainees working in acute inpatient care settings. Methods: We will conduct a multicenter randomized controlled trial using a wait-list control group design. Randomization will be stratified by hospital and job status (nurse or nursing trainee). Recruitment will take place on the web and offline during the working hours of nurses and nursing trainees. The intervention group will receive a digitally supported mindfulness intervention, which will comprise an app, 2 web-based workshops, and a workbook, whereas the wait-list control group will be scheduled to receive the same intervention 14 weeks later. The 2 web-based workshops will be led by a certified mindfulness-based stress reduction trainer. Nurses will use the app and the workbook independently. Self-report web-based surveys will be conducted on the web at baseline, at 10 weeks after allocation, at 24 weeks after allocation, and at 38 weeks after allocation. Outcomes of interest will include perceived stress (primary outcome), health- and work-related variables, and variables related to adherence and acceptability of the digitally supported mindfulness intervention. We will perform intention-to-treat and per-protocol analyses. Results: Data collection will be completed by the beginning of August 2022. Data analyses will be completed by December 2022. Conclusions: Our study design, including long-term follow-up and the investigation of variables related to adherence and acceptability, will ensure rigorous evaluation of effectiveness and efficacy. Relative to costly in-person intervention efforts, this program may present a cost-effective and potentially highly scalable alternative. Findings regarding effectiveness, efficacy, adherence, and acceptability will inform stakeholders? decisions regarding the implementation of similar interventions to promote the well-being of nurses and nursing trainees, which may, in turn, alleviate detrimental stress-related outcomes (eg, burnout) because of work-related demands. Trial Registration: German Clinical Trials Register DRKS00025997; https://tinyurl.com/433cas7u International Registered Report Identifier (IRRID): DERR1-10.2196/37195 UR - https://www.researchprotocols.org/2022/8/e37195 UR - http://dx.doi.org/10.2196/37195 UR - http://www.ncbi.nlm.nih.gov/pubmed/35916708 ID - info:doi/10.2196/37195 ER - TY - JOUR AU - Huberty, Jennifer AU - Bhuiyan, Nishat AU - Eckert, Ryan AU - Larkey, Linda AU - Petrov, Megan AU - Todd, Michael AU - Mesa, Ruben PY - 2022/7/1 TI - Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance JO - JMIR Res Protoc SP - e39007 VL - 11 IS - 7 KW - hematological cancers KW - mobile health KW - mHealth KW - meditation KW - sleep disturbance KW - mobile phone N2 - Background: To address the need for long-term, accessible, nonpharmacologic interventions targeting sleep in patients with chronic hematological cancer, we propose the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app, Calm, on sleep disturbance in this population. Objective: This study aims to test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group in improving the primary outcome of self-reported sleep disturbance, as well as secondary sleep outcomes, including sleep impairment and sleep efficiency; test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group on inflammatory markers, fatigue, and emotional distress; and explore free-living use during a 12-week follow-up period and the sustained effects of Calm in patients with chronic hematological cancer. Methods: In a double-blinded randomized controlled trial, we will recruit 276 patients with chronic hematological cancer to an 8-week app-based wellness intervention?the active, daily, app-based meditation intervention or the health education podcast app control group, followed by a 12-week follow-up period. Participants will be asked to use their assigned app for at least 10 minutes per day during the 8-week intervention period; complete web-based surveys assessing self-reported sleep disturbance, fatigue, and emotional distress at baseline, 8 weeks, and 20 weeks; complete sleep diaries and wear an actigraphy device during the 8-week intervention period and at 20 weeks; and complete blood draws to assess inflammatory markers (tumor necrosis factor-?, interleukin-6, interleukin-8, and C-reactive protein) at baseline, 8 weeks, and 20 weeks. Results: This project was funded by the National Institutes of Health National Cancer Institute (R01CA262041). The projects began in April 2022, and study recruitment is scheduled to begin in October 2022, with a total project duration of 5 years. We anticipate that we will be able to achieve our enrollment goal of 276 patients with chronic hematological cancers within the allotted project time frame. Conclusions: This research will contribute to broader public health efforts by providing researchers and clinicians with an evidence-based commercial product to improve sleep in the long term in an underserved and understudied cancer population with a high incidence of sleep disturbance. Trial Registration: ClinicalTrials.gov NCT05294991; https://clinicaltrials.gov/ct2/show/NCT05294991 International Registered Report Identifier (IRRID): PRR1-10.2196/39007 UR - https://www.researchprotocols.org/2022/7/e39007 UR - http://dx.doi.org/10.2196/39007 UR - http://www.ncbi.nlm.nih.gov/pubmed/35776489 ID - info:doi/10.2196/39007 ER - TY - JOUR AU - Gomaa, Sameh AU - West, Carly AU - Lopez, Maria Ana AU - Zhan, Tingting AU - Schnoll, Max AU - Abu-Khalaf, Maysa AU - Newberg, Andrew AU - Wen, Kuang-Yi PY - 2022/6/21 TI - A Telehealth-Delivered Tai Chi Intervention (TaiChi4Joint) for Managing Aromatase Inhibitor?Induced Arthralgia in Patients With Breast Cancer During COVID-19: Longitudinal Pilot Study JO - JMIR Form Res SP - e34995 VL - 6 IS - 6 KW - breast cancer KW - arthralgia KW - tai chi KW - telehealth, pain KW - mind-body therapy N2 - Background: Estrogen receptor?positive breast cancer is the most common type of breast cancer in postmenopausal women. Aromatase inhibitors (AIs) are the endocrine therapy of choice recommended for these patients. Up to 50% of those treated with an AI develop arthralgia, often resulting in poor adherence and decreased quality of life. Objective: The study is a single-arm longitudinal pilot study aiming to evaluate the safety, feasibility, acceptability, and potential efficacy of TaiChi4Joint, a remotely delivered 12-week tai chi intervention designed to relieve AI-induced joint pain. Methods: Women diagnosed with stage 0-III breast cancer who received an AI for at least 2 months and reported arthralgia with a ?4 score on a 0 to 10 scale for joint pain were eligible for study enrollment. Participants were encouraged to join tai chi classes delivered over Zoom three times a week for 12 weeks. Program engagement strategies included using a private Facebook study group and a Box cloud for archiving live class recordings. The program uses SMS text messaging and emails with periodic positive quotes and evidence-based information on tai chi for facilitating community bonding and class attendance. Participants were invited to complete the following assessments at baseline and at 1-, 2-, and 3-month intervals from study enrollment: Brief Pain Inventory, Western Ontario and McMaster University Osteoarthritis Index (WOMAC), The Australian Canadian Osteoarthritis Hand Index (AUSCAN), Fatigue Symptom Inventory, Hot Flash Related Daily Interference Scale (HFRDIS), Pittsburgh Sleep Quality Index (PSQI), and Center for Epidemiological Studies?Depression (CES-D). Results: A total of 55 eligible patients were invited to participate, and 39 (71%) consented and completed the baseline assessments. Participants attended 61% (median) of the suggested classes, with no tai chi?related adverse events reported. Of the 39 participants, 22 completed the 3-month follow-up assessment with a 56% retention rate. Study participants reported improvement from baseline compared to 3 months as follows (paired t test): Brief Pain Inventory (P<.001), AUSCAN pain subscale (P=.007), AUSCAN function subscale (P=.004), Fatigue Symptom Inventory (P=.004) and PSQI (P<.001), and HFRDIS (P=.02) and CES-D (P<.001). In particular, for our primary end point of interest, improvements in hip and knee symptoms, measured by WOMAC?s three subscales, were clinically meaningful and statistically significant when adjusted for multiple comparisons from baseline to 3 months post intervention. Conclusions: The COVID-19 global pandemic has resulted in the need to rethink how mind-body therapies can be delivered. This study demonstrated the feasibility, acceptability, and potential efficacy of a telehealth-based tai chi intervention for reducing AI-induced arthralgia. The intervention decreased patient-reported pain and stiffness, and improved sleep quality and depressive symptoms. Fully powered, large, telehealth-based tai chi trials for AI-associated arthralgia are needed considering our promising findings. Trial Registration: ClinicalTrials.gov NCT04716920; https://www.clinicaltrials.gov/ct2/show/NCT04716920 UR - https://formative.jmir.org/2022/6/e34995 UR - http://dx.doi.org/10.2196/34995 UR - http://www.ncbi.nlm.nih.gov/pubmed/35727609 ID - info:doi/10.2196/34995 ER - TY - JOUR AU - Sado, Mitsuhiro AU - Yamada, Masashi AU - Ninomiya, Akira AU - Nagaoka, Maki AU - Goto, Naho AU - Koreki, Akihiro AU - Nakagawa, Atsuo AU - Segal, Zindel AU - Mimura, Masaru PY - 2022/6/13 TI - Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e36012 VL - 11 IS - 6 KW - mindfulness-based cognitive therapy KW - mindfulness KW - cognitive therapy KW - occupational health KW - workplace KW - randomized controlled trial KW - cost-effectiveness KW - cost KW - online KW - internet-based KW - eHealth KW - mental health KW - heath outcome KW - work KW - stress KW - burnout KW - productivity KW - employee N2 - Background: Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated. Objective: The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control. Methods: We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation. Results: We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024. Conclusions: The novelty of the study is that (1) it will investigate bMBCT?s effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873 International Registered Report Identifier (IRRID): DERR1-10.2196/36012 UR - https://www.researchprotocols.org/2022/6/e36012 UR - http://dx.doi.org/10.2196/36012 UR - http://www.ncbi.nlm.nih.gov/pubmed/35387762 ID - info:doi/10.2196/36012 ER - TY - JOUR AU - Reynolds, Allie AU - Hamidian Jahromi, Alireza PY - 2022/6/10 TI - Improving Postoperative Care Through Mindfulness-Based and Isometric Exercise Training Interventions: Systematic Review JO - JMIR Perioper Med SP - e34651 VL - 5 IS - 1 KW - postoperative care KW - mindfulness KW - isometric exercise KW - mindfulness-based interventions KW - meditation KW - cognitive therapy KW - improving care KW - postoperative KW - systematic review N2 - Background: Mindfulness-based cognitive therapy and isometric exercise training (IET) interventions are relatively new approaches to maintain physical functioning, alleviate pain, prevent joint stiffness and muscular atrophy, and positively influence other postoperative care outcomes. Objective: The aim of this review was to identify the impacts of mindfulness-based interventions (MBIs) and IET and, more specifically, their combination, which have not previously been assessed to our knowledge. Methods: Studies were identified by searching the PubMed and Cochrane databases within the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) algorithm format and using relevant keyword combinations, which resulted in 39 studies meeting the inclusion criteria. Results: In general, MBI was shown to positively impact both pain relief and physical functioning, while IET positively impacted physical functioning. Numerous other benefits, including improved quality of life and decreased postoperative opioid use, were also described from both interventions; however, further research is needed to confirm these findings as well as to determine other possible benefits. No studies were found that combined MBI and IET. Conclusions: Despite many positive results from each individual intervention, there is a lack of information about how the combination of MBI and IET might impact postoperative care. The combination of these two interventions might prove to be more effective than each individual intervention alone, and the findings from this review show that they could even be complementary. Going forward, research should be expanded to study the possible benefits of the combination of MBI and IET in postoperative care routines as well as other possible combinations. UR - https://periop.jmir.org/2022/1/e34651 UR - http://dx.doi.org/10.2196/34651 UR - http://www.ncbi.nlm.nih.gov/pubmed/35687415 ID - info:doi/10.2196/34651 ER - TY - JOUR AU - Pace, W. Thaddeus W. AU - Zeiders, H. Katharine AU - Cook, H. Stephanie AU - Sarsar, D. Evelyn AU - Hoyt, T. Lindsay AU - Mirin, L. Nicholas AU - Wood, P. Erica AU - Tatar, Raquel AU - Davidson, J. Richard PY - 2022/6/8 TI - Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Meditation Intervention to Decrease Firefighter Psychological Distress and Burnout: A One-Group Pilot Study JO - JMIR Form Res SP - e34951 VL - 6 IS - 6 KW - firefighter KW - meditation KW - smartphone app KW - anxiety KW - cortisol KW - digital health KW - mobile health KW - mHealth KW - mental health KW - burnout KW - stress management N2 - Background: Firefighters are often exposed to occupational stressors that can result in psychological distress (ie, anxiety and depression) and burnout. These occupational stressors have only intensified with the onset of the COVID-19 pandemic and will likely persist in the postpandemic world. Objective: To address occupational stressors confronting firefighters, we pilot tested a novel, cost-effective, smartphone app?based meditation intervention created by Healthy Minds Innovations that focused on mindfulness (awareness) training along with practices designed to cultivate positive relationships (connection), insight into the nature of the self (insight), and a sense of purpose in the context of challenge (purpose) with a sample of professional firefighters from a large metropolitan area in southwestern United States. Methods: A total of 35 participants were recruited from a closed online group listserv and completed the self-guided 10-unit meditation app over the course of 10 days, at 1 unit per day. We assessed anxiety symptoms, depression symptoms, burnout, and negative affect as well as saliva diurnal cortisol rhythm, an objective indicator of stress-related biology, before and after use of the meditation app. Results: This study demonstrated the meditation app was both feasible and acceptable for use by the majority of firefighters. We also found significant reductions in firefighters? anxiety (P=.01), burnout (P=.05), and negative affect (P=.04), as well as changes in cortisol diurnal rhythm, such as waking cortisol (P=.02), from before to after use of the meditation app. Conclusions: Our study findings call for future research to demonstrate the efficacy of this meditation app to reduce psychological distress and burnout in firefighters. UR - https://formative.jmir.org/2022/6/e34951 UR - http://dx.doi.org/10.2196/34951 UR - http://www.ncbi.nlm.nih.gov/pubmed/35675115 ID - info:doi/10.2196/34951 ER - TY - JOUR AU - James-Palmer, Aurora AU - Anderson, Zambo Ellen AU - Daneault, Jean-Francois PY - 2022/6/6 TI - Remote Delivery of Yoga Interventions Through Technology: Scoping Review JO - J Med Internet Res SP - e29092 VL - 24 IS - 6 KW - complementary therapies KW - mind-body KW - remote delivery KW - telerehabilitation KW - eHealth KW - yoga KW - technology N2 - Background: The popularity of yoga and the understanding of its potential health benefits have recently increased. Unfortunately, not everyone can easily engage in in-person yoga classes. Over the past decade, the use of remotely delivered yoga has increased in real-world applications. However, the state of the related scientific literature is unclear. Objective: This scoping review aimed to identify gaps in the literature related to the remote delivery of yoga interventions, including gaps related to the populations studied, the yoga intervention characteristics (delivery methods and intervention components implemented), the safety and feasibility of the interventions, and the preliminary efficacy of the interventions. Methods: This scoping review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Item for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Scientific databases were searched throughout April 2021 for experimental studies involving yoga delivered through technology. Eligibility was assessed through abstract and title screening and a subsequent full-article review. The included articles were appraised for quality, and data were extracted from each article. Results: A total of 12 studies of weak to moderate quality were included. Populations varied in physical and mental health status. Of the 12 studies, 10 (83%) implemented asynchronous delivery methods (via prerecorded material), 1 (8%) implemented synchronous delivery methods (through videoconferencing), and 1 (8%) did not clearly describe the delivery method. Yoga interventions were heterogeneous in style and prescribed dose but primarily included yoga intervention components of postures, breathing, and relaxation and meditation. Owing to the heterogeneous nature of the included studies, conclusive findings regarding the preliminary efficacy of the interventions could not be ascertained. Conclusions: Several gaps in the literature were identified. Overall, this review showed that more attention needs to be paid to yoga intervention delivery methods while designing studies and developing interventions. Decisions regarding delivery methods should be justified and not made arbitrarily. Studies of high methodological rigor and robust reporting are needed. UR - https://www.jmir.org/2022/6/e29092 UR - http://dx.doi.org/10.2196/29092 UR - http://www.ncbi.nlm.nih.gov/pubmed/35666562 ID - info:doi/10.2196/29092 ER - TY - JOUR AU - Laird, Breanne AU - Puzia, Megan AU - Larkey, Linda AU - Ehlers, Diane AU - Huberty, Jennifer PY - 2022/5/24 TI - A Mobile App for Stress Management in Middle-Aged Men and Women (Calm): Feasibility Randomized Controlled Trial JO - JMIR Form Res SP - e30294 VL - 6 IS - 5 KW - stress KW - meditation KW - mHealth KW - COVID-19 KW - mobile app KW - mental health KW - mindfulness KW - digital intervention KW - psychological outcomes N2 - Background: Middle-aged adults (40-65 years) report higher stress levels than most other age groups. There is a need to determine the feasibility of using a meditation app to reduce stress and improve stress-related outcomes in middle-aged adults with a focus on men, as previous meditation app?based studies have reported a low proportion of or even no male participants. Objective: This study aims to (1) determine the feasibility (ie, acceptability and demand with a focus on men) of a consumer-based meditation app (Calm), to reduce stress among middle-aged adults reporting elevated stress levels, and (2) explore the preliminary effects of Calm on perceived stress, psychological outcomes (anxiety, depressive symptoms, mindfulness, and general coping), health behaviors (physical activity and eating habits), and COVID-19 perceptions. Methods: This feasibility randomized controlled trial evaluated an app-based meditation intervention in middle-aged adults (N=83) with elevated stress levels (ie, Perceived Stress Scale score ?15) and limited or no previous experience with meditation. Participants were randomized to the intervention group (Calm app) or a control (educational podcasts; POD) group. Participants completed self-report assessments at baseline and postintervention (week 4). Feasibility was measured as acceptability and demand using Bowen framework. Feasibility and COVID-19 perceptions data were examined using descriptive statistics, and preliminary effects were evaluated using repeated measures analysis of variance. Results: Participants were satisfied with Calm (27/28, 96%) and found it appropriate or useful (26/28, 93%). Most reported they would likely continue using the Calm app (18/28, 64%). More Calm users reported satisfaction, appropriateness or usefulness, and intent to continue app use than POD users. Calm users (n=33) completed a mean of 20 (SD 31.1) minutes of meditation on the days they meditated and 103 (SD 109.1) minutes of meditation per week. The average adherence rate to the prescribed meditation was 71% among Calm app users, compared to 62% among POD users. Recruitment rate of men was 35% (29/83). Of those randomized to Calm, 55% (15/29) were men, and retention among them was higher (14/15, 93%) than that among women (12/20, 60%). No significant within or between group differences were observed. Conclusions: A 4-week, app-based mindfulness meditation intervention (Calm) may be feasible for middle-aged adults and a useful stress-management tool. Calm users expressed satisfaction with the app and felt it was appropriate and useful. Significant improvements in perceived stress and psychological outcomes or stress-related health behaviors were not observed. Even though men spent less time in meditation than women did and completed fewer weekly sessions, they were more likely to adhere to the prescription. Further research is needed for improving stress and stress-related outcomes among middle-aged adults with emphasis on the effects of mindfulness meditation apps for men. Trial Registration: ClinicalTrials.gov NCT04272138; https://clinicaltrials.gov/ct2/show/NCT04272138 UR - https://formative.jmir.org/2022/5/e30294 UR - http://dx.doi.org/10.2196/30294 UR - http://www.ncbi.nlm.nih.gov/pubmed/34989677 ID - info:doi/10.2196/30294 ER - TY - JOUR AU - Thimmapuram, Jayaram AU - Patel, Kamlesh AU - Madhusudhan, K. Divya AU - Deshpande, Snehal AU - Bouderlique, Ekta AU - Nicolai, Veronique AU - Rao, Raghavendra PY - 2022/5/17 TI - Health-Related Quality of Life Outcomes With Regular Yoga and Heartfulness Meditation Practice: Results From a Multinational, Cross-sectional Study JO - JMIR Form Res SP - e37876 VL - 6 IS - 5 KW - yoga KW - meditation KW - health-related quality of life KW - Heartfulness KW - COVID-19 KW - healthy living KW - wellness KW - quality of life KW - stress KW - mental health KW - psychological health KW - online survey KW - cross-sectional study KW - health outcome N2 - Background: Although the benefits of yoga are well established across the world, there are limited studies exploring the long-term interrelation between yoga, meditation, and health. Specifically, there is limited research exploring the differences in health-related quality of life (HRQOL) among regular meditators and nonmeditators. Objective: This study explored the differences in 7 domains of HRQOL (including quality of life, ability to adopt a healthy lifestyle, ability to relax, frequency of nervousness and stress, coping with day-to-day stress, workplace productivity, and staying healthy during the COVID-19 pandemic) among practitioners of yoga and meditation. Methods: A cross-sectional, online survey was distributed to all members who participated in a 100-day yoga and meditation program, culminating in the International Day of Yoga event, organized by the Heartfulness Institute in partnership with the Central Council for Research in Yoga and Naturopathy, Ministry of Ayush, SVYASA Yoga University, and Patanjali Yoga Institute, India. The program consisted of daily virtual yoga, meditation, and speaker sessions. The data were analyzed by nonparametric Mann-Whitney U test and Kruskal-Wallis tests for continuous variables and chi-square test for categorical variables. Results: A total of 3164 participants from 39 countries completed the survey. Mean age was 33.8 (SD 13.6) years. The majority of the participants were female (n=1643, 52%) and students (n=1312, 41.5%). Regular yoga and meditation practice was associated with a positive impact on all 7 domains of HRQOL (Mann-Whitney P<.05 and ?2P<.05). Notably, experienced Heartfulness (?2 years) meditators reported better outcomes in all the domains of HRQOL as compared to those not currently practicing this form of meditation and participants with ?1 year of Heartfulness meditation experience (P<.05). Conclusions: This is one of the first cross-sectional studies to explore HRQOL outcomes among participants of a 100-day virtual yoga and meditation program. Overall, a yoga and meditation practice was found to be an effective tool for promoting HRQOL. Regular yoga and meditation practice was associated with factors promoting health and well-being, with long-term meditation practice associated with increased benefits. UR - https://formative.jmir.org/2022/5/e37876 UR - http://dx.doi.org/10.2196/37876 UR - http://www.ncbi.nlm.nih.gov/pubmed/35470800 ID - info:doi/10.2196/37876 ER - TY - JOUR AU - Gardiner, Paula AU - McGonigal, Lisa AU - Villa, Ariel AU - Kovell, C. Lara AU - Rohela, Pallavi AU - Cauley, Andrew AU - Rinker, Diana AU - Olendzki, Barbara PY - 2022/5/16 TI - Our Whole Lives for Hypertension and Cardiac Risk Factors?Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial JO - JMIR Form Res SP - e29227 VL - 6 IS - 5 KW - hypertension KW - health disparities KW - teaching kitchen KW - technology KW - mindfulness KW - low income KW - medical group visits KW - mobile phone N2 - Background: Hypertension (HTN) affects millions of Americans. Our Whole Lives: an eHealth toolkit for Hypertension and Cardiac Risk Factors (OWL-H) is an eHealth platform that teaches evidence-based lifestyle strategies, such mindfulness and cooking skills, to improve self-management of HTN. Objective: The primary goal of this pilot study was to evaluate the feasibility of OWL-H combined with teaching kitchen medical group visits (TKMGVs) in a low-income population of participants with HTN. Methods: We conducted a pre-post 8-week study to assess the feasibility of a hybrid program (a web-based 9-module self-management program, which includes mindfulness and Mediterranean and Dietary Approaches to Stop Hypertension diet) accompanied by 3 in-person TKMGVs among patients with HTN. Data including demographics, platform use, and satisfaction after using OWL-H were examined. Outcome data collected at baseline and 8 weeks included the Mediterranean Diet Questionnaire, Hypertension Self-Care Profile Self-Efficacy Instrument, Blood Pressure Knowledge Questionnaire, and the number of self-reported blood pressure readings. For the statistical analysis, we used descriptive statistics, paired sample t tests (1-tailed), and qualitative methods. Results: Of the 25 enrolled participants, 22 (88%) participants completed the study. Participants? average age was 57 (SD 12.1) years, and 46% (11/24) of them reported a household income 18 years with chronic health conditions were included in the study. Mindfulness interventions, including those in combination with mindfulness-based cognitive therapy, delivered on the web through the internet or smartphone technology were included. Interventions lasted at least 2 weeks. Studies with a randomized controlled trial design or a pilot randomized controlled trial design were included. Engagement strategies, including web-based program features and facilitator-led strategies, adherence, and retention, were included. Results: A total of 1265 articles were screened, of which 19 were relevant and were included in the review. On average, 70.98% (2258/3181) of the study participants were women with a mean age of 46 (SD 13) years. Most commonly, mindfulness programs were delivered to people living with mental health conditions (8/19, 42%). Of the 19 studies, 8 (42%) used only program features to encourage adherence, 5 (26%) used facilitator-led strategies, and 6 (32%) used a combination of the two. Encouraging program adherence was the most common engagement strategy used, which was used in 77% (10/13) of the facilitator-led studies and 57% (8/14) of the program feature studies. Nearly two-thirds (63%) of the studies provided a definition of adherence, which varied between 50% and 100% completion across studies. The overall mean participant compliance to the mindfulness programs was 56% (SD 15%). Most studies (10/19, 53%) had a long-term follow-up, with the most common follow-up period being 12 weeks after intervention (3/10, 30%). After the intervention, the mean retention was 78% (SD 15%). Conclusions: Engagement strategies in web-based mindfulness programs comprise reminders to use the program. Other features may be suitable for encouraging adherence to interventions, and a facilitator-led component may result in higher retention. There is variance in the way adherence is measured, and intervention lengths and follow-up periods are inconsistent. More thorough reporting and a standardized framework for measuring adherence are needed to more accurately assess adherence and engagement strategies. UR - https://www.jmir.org/2022/1/e30026 UR - http://dx.doi.org/10.2196/30026 UR - http://www.ncbi.nlm.nih.gov/pubmed/35019851 ID - info:doi/10.2196/30026 ER - TY - JOUR AU - Cincidda, Clizia AU - Pizzoli, Maria Silvia Francesca AU - Pravettoni, Gabriella PY - 2022/1/11 TI - Remote Psychological Interventions for Fear of Cancer Recurrence: Scoping Review JO - JMIR Cancer SP - e29745 VL - 8 IS - 1 KW - fear of cancer recurrence KW - cognitive behavioral therapy KW - acceptance and commitment therapy KW - mindfulness KW - eHealth KW - blended intervention N2 - Background: Patients with cancer and survivors may experience the fear of cancer recurrence (FCR), a preoccupation with the progression or recurrence of cancer. During the spread of COVID-19 in 2019, patients and survivors experienced increased levels of FCR. Hence, there is a greater need to identify effective evidence-based treatments to help people cope with FCR. Remotely delivered interventions might provide a valuable means to address FCR in patients with cancer. Objective: The aim of this study is to first discuss the available psychological interventions for FCR based on traditional cognitive behavioral therapies (CBTs) or contemporary CBTs, in particular, mindfulness and acceptance and commitment therapy, and then propose a possible approach based on the retrieved literature. Methods: We searched key electronic databases to identify studies that evaluated the effect of psychological interventions such as CBT on FCR among patients with cancer and survivors. Results: Current evidence suggests that face-to-face psychological interventions for FCR are feasible, acceptable, and efficacious for managing FCR. However, there are no specific data on the interventions that are most effective when delivered remotely. Conclusions: CBT interventions can be efficacious in managing FCR, especially at posttreatment, regardless of whether it is delivered face to face, on the web, or using a blended approach. To date, no study has simultaneously compared the effectiveness of face-to-face, web-based, and blended interventions. On the basis of the retrieved evidence, we propose the hypothetical program of an intervention for FCR based on both traditional CBT and contemporary CBT, named Change Of Recurrence, which aims to improve the management of FCR in patients with cancer and survivors. UR - https://cancer.jmir.org/2022/1/e29745 UR - http://dx.doi.org/10.2196/29745 UR - http://www.ncbi.nlm.nih.gov/pubmed/35014956 ID - info:doi/10.2196/29745 ER - TY - JOUR AU - Stecher, Chad AU - Sullivan, Mariah AU - Huberty, Jennifer PY - 2021/12/22 TI - Using Personalized Anchors to Establish Routine Meditation Practice With a Mobile App: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e32794 VL - 9 IS - 12 KW - mindfulness KW - meditation KW - mobile meditation app KW - behavioral persistence KW - habit formation KW - randomized controlled trial KW - mental health KW - physical health KW - app engagement KW - routine N2 - Background: Physical and mental health benefits can be attained from persistent, long-term performance of mindfulness meditation with a mobile meditation app, but in general, few mobile health app users persistently engage at a level necessary to attain the corresponding health benefits. Anchoring or pairing meditation with a mobile app to an existing daily routine can establish an unconsciously initiated meditation routine that may improve meditation persistence. Objective: The purpose of this study was to test the use of either personalized anchors or fixed anchors for establishing a persistent meditation app routine with the mobile app, Calm. Methods: We conducted a randomized controlled trial and randomly assigned participants to one of 3 study groups: (1) a personalized anchor (PA) group, (2) fixed anchor (FA) group, or (3) control group that did not use the anchoring strategy. All participants received app-delivered reminder messages to meditate for at least 10 minutes a day using the Calm app for an 8-week intervention period, and app usage data continued to be collected for an additional 8-week follow-up period to measure meditation persistence. Baseline, week 8, and week 16 surveys were administered to assess demographics, socioeconomic status, and changes in self-reported habit strength. Results: A total of 101 participants across the 3 study groups were included in the final analysis: (1) PA (n=56), (2) FA (n=49), and (3) control group (n=62). Participants were predominantly White (83/101, 82.2%), female (77/101, 76.2%), and college educated (ie, bachelor?s or graduate degree; 82/101, 81.2%). The FA group had a significantly higher average odds of daily meditation during the intervention (1.14 odds ratio [OR]; 95% CI 1.02-1.33; P=.04), and all participants experienced a linear decline in their odds of daily meditation during the 8-week intervention (0.96 OR; 95% CI 0.95-0.96; P<.001). Importantly, the FA group showed a significantly smaller decline in the linear trend of their odds of daily meditation during the 8-week follow-up (their daily trend increased by 1.04 OR from their trend during the intervention; 95% CI 1.01-1.06; P=.03). Additionally, those who more frequently adhered to their anchoring strategy during the intervention typically used anchors that occurred in the morning and showed a significantly smaller decline in their odds of daily meditation during the 8-week follow-up period (1.13 OR; 95% CI 1.02-1.35; P=.007). Conclusions: The FA group had more persistent meditation with the app, but participants in the FA or PA groups who more frequently adhered to their anchoring strategy during the intervention had the most persistent meditation routines, and almost all of these high anchorers used morning anchors. These findings suggest that the anchoring strategy can create persistent meditation routines with a mobile app. However, future studies should combine anchoring with additional intervention tools (eg, incentives) to help more participants successfully establish an anchored meditation routine. Trial Registration: ClinicalTrials.gov NCT04378530; https://clinicaltrials.gov/ct2/show/NCT04378530 UR - https://mhealth.jmir.org/2021/12/e32794 UR - http://dx.doi.org/10.2196/32794 UR - http://www.ncbi.nlm.nih.gov/pubmed/34941558 ID - info:doi/10.2196/32794 ER - TY - JOUR AU - Roy, Alexandra AU - Hoge, A. Elizabeth AU - Abrante, Pablo AU - Druker, Susan AU - Liu, Tao AU - Brewer, A. Judson PY - 2021/12/2 TI - Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial JO - J Med Internet Res SP - e26987 VL - 23 IS - 12 KW - anxiety KW - generalized anxiety disorder KW - worry KW - mindfulness KW - mHealth KW - digital therapeutics KW - mobile phone N2 - Background: Current treatments for generalized anxiety disorder (GAD) often yield suboptimal outcomes, partly because of insufficient targeting of underlying psychological mechanisms (eg, avoidance reinforcement learning). Mindfulness training (MT) has shown efficacy for anxiety; yet, widespread adoption has been limited, partly because of the difficulty in scaling in-person?based delivery. Digital therapeutics are emerging as potentially viable treatments; however, very few have been empirically validated. Objective: The aim of this study is to test the efficacy and mechanism of an app-delivered MT that was designed to target a potential mechanism of anxiety (reinforcement learning), based on which previous studies have shown concern regarding feedback and the perpetuation of anxiety through negative reinforcement. Methods: Individuals with GAD were recruited using social media advertisements and randomized during an in-person visit to receive treatment as usual (n=33) or treatment as usual+app?delivered MT (Unwinding Anxiety; n=32). The latter was composed of 30 modules to be completed over a 2-month period. Associated changes in outcomes were assessed using self-report questionnaires 1 and 2 months after treatment initiation. Results: We randomized 65 participants in this study, and a modified intent-to-treat approach was used for analysis. The median number of modules completed by the MT group was 25.5 (IQR 17) out of 30; 46% (13/28) of the participants completed the program. In addition, the MT group demonstrated a significant reduction in anxiety (GAD-7) compared with the control group at 2 months (67% vs 14%; median change in GAD-7: ?8.5 [IQR 6.5] vs ?1.0 [IQR 5.0]; P<.001; 95% CI 6-10). Increases in mindfulness at 1 month (nonreactivity subscale) mediated decreases in worry at 2 months (Penn State Worry Questionnaire; P=.02) and decreases in worry at 1 month mediated reductions in anxiety at 2 months (P=.03). Conclusions: To our knowledge, this is the first report on the efficacy and mechanism of an app-delivered MT for GAD. These findings demonstrate the clinical efficacy of MT as a digital therapeutic for individuals with anxiety (number needed to treat=1.6). These results also link recent advances in our mechanistic understanding of anxiety with treatment development, showing that app-delivered MT targets key reinforcement learning pathways, resulting in tangible, clinically meaningful reductions in worry and anxiety. Evidence-based, mechanistically targeted digital therapeutics have the potential to improve health at a population level at a low cost. Trial Registration: ClinicalTrials.gov NCT03683472; https://clinicaltrials.gov/ct2/show/NCT03683472 UR - https://www.jmir.org/2021/12/e26987 UR - http://dx.doi.org/10.2196/26987 UR - http://www.ncbi.nlm.nih.gov/pubmed/34860673 ID - info:doi/10.2196/26987 ER - TY - JOUR AU - Goodridge, Donna AU - Reis, Nathan AU - Neiser, Jenna AU - Haubrich, Tim AU - Westberg, Bev AU - Erickson-Lumb, Laura AU - Storozinski, Jo AU - Gonzales, Cesar AU - Michael, Joanne AU - Cammer, Allison AU - Osgood, Nathaniel PY - 2021/11/26 TI - An App-Based Mindfulness-Based Self-compassion Program to Support Caregivers of People With Dementia: Participatory Feasibility Study JO - JMIR Aging SP - e28652 VL - 4 IS - 4 KW - virtual support programs KW - caregivers KW - dementia KW - mindfulness KW - self-compassion KW - mobile health KW - mobile applications KW - elderly KW - older adults KW - usability KW - feasibility KW - smartphone app KW - mobile phone N2 - Background: The number of persons with dementia is steadily growing, as is the number of individuals supporting persons with dementia. Primary caregivers of persons with dementia are most often family members or spouses of the persons with dementia, and they are more likely to experience increased stress and other negative effects than individuals who are not primary caregivers. Although in-person support groups have been shown to help buffer the negative impacts of caregiving, some caregivers live in isolated or rural communities and are unable to make the burdensome commitment of traveling to cities. Using an interdisciplinary approach, we developed a mobile smartphone support app designed for primary caregivers of persons with dementia, with the goal of reducing caregiver burden and easing stress. The app features a 12-week intervention, largely rooted in mindfulness-based self-compassion (MBSC), because MBSC has been linked to minimizing stress, depression, and anxiety. Objective: The primary objectives of our program are twofold: to explore the feasibility of a 12-week mobile support program and to conduct an initial efficacy evaluation of changes in perceived caregiver burden, coping styles, and emotional well-being of caregivers before and after the program. Methods: Our feasibility study used a 2-phase participatory pretest and posttest design, focusing on acceptability, demand, practicality, implementation, and efficacy. At phase I, we recruited 57 primary caregivers of persons with dementia (mean age 76.3, SD 12.9 years), comprising spouses (21/57, 37%), children (21/57, 37%), and friends or relatives (15/57, 26%) of persons with dementia, of whom 29 (51%) completed all measures at both pre- and postprogram. The content of the program featured a series of MBSC podcasts. Our primary outcome measure was caregiver burden, with secondary outcome measures including coping styles and emotional well-being. Daily ecological momentary assessments enabled us to ask participants, ?How are you feeling today?? Phase II of our study involved semistructured follow-up interviews with most participants (n=21) who completed phase I. Results: Our findings suggest that our app or program meets the feasibility criteria examined. Notably, participants generally accepted the program and believed it could be a useful resource. Emotional well-being increased significantly (P=.04), and emotion-based coping significantly decreased (P=.01). Participants generally considered the app or program to be a helpful resource. Conclusions: Although there were no significant changes in caregiver burden, we were encouraged by the increased emotional well-being of our participants following the completion of our program. We also conclude that our app or program demonstrated feasibility (ie, acceptability, practicality, implementation, and efficacy) and can provide a much-needed resource for primary caregivers of persons with dementia. In the subsequent version of the program, we will respond to participant feedback by incorporating web-based weekly sessions and incorporating an outcome measure of self-compassion. UR - https://aging.jmir.org/2021/4/e28652 UR - http://dx.doi.org/10.2196/28652 UR - http://www.ncbi.nlm.nih.gov/pubmed/34842530 ID - info:doi/10.2196/28652 ER - TY - JOUR AU - Hopkins, M. Christina AU - Miller, N. Hailey AU - Brooks, L. Taylor AU - Mo-Hunter, Lihua AU - Steinberg, M. Dori AU - Bennett, G. Gary PY - 2021/11/25 TI - Designing Ruby: Protocol for a 2-Arm, Brief, Digital Randomized Controlled Trial for Internalized Weight Bias JO - JMIR Res Protoc SP - e31307 VL - 10 IS - 11 KW - obesity KW - stigma KW - mHealth KW - mindfulness KW - self-compassion KW - mobile phone N2 - Background: Weight bias internalization, also known as weight self-stigma, is a serious health concern for individuals with higher body weight. Weight bias internalization is associated with the greater avoidance of health care and health-promoting activities, disordered eating, social isolation, and weight gain. Elevated weight bias internalization has been associated with low self-compassion, yet few investigations have explored self-compassion as a potential mechanism for reducing internalized weight bias. Objective: Ruby is a 2-arm randomized controlled trial that was designed to test the efficacy of a 4-week digital self-compassion intervention to reduce internalized weight bias compared with a wait-list control. Methods: Adults with elevated internalized weight bias and a BMI of >30 kg/m2 (N=80) were recruited. Ruby is a standalone digital trial that will be delivered entirely via a smartphone and will involve web-based data collection and text messages. The intervention content will include psychoeducation and daily mindfulness practices with a focus on self-compassion and body concerns. We will use intent-to-treat analyses to examine changes in weight bias internalization throughout time by treatment arm. The analyses will be conducted by using one-way analysis of covariance models and linear mixed models. Results: The protocol was designed in May 2020 and approved in December 2020. Data collection is currently underway. Conclusions: Ruby will be the first digital standalone, self-compassion?based intervention designed to reduce internalized weight bias. Owing to its standalone digital delivery, Ruby may be a highly scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. We expect Ruby to be accessible to many, as participants can access the digital intervention at times of the day that are the most convenient in their schedule and are not burdened by in-person time commitments, which can be a barrier for participants with competing demands on their time and resources. If efficacious, Ruby will be poised to expand a burgeoning body of literature related to psychological intervention in this area. Trial Registration: ClinicalTrials.gov NCT04678973; https://clinicaltrials.gov/ct2/show/NCT04678973 International Registered Report Identifier (IRRID): DERR1-10.2196/31307 UR - https://www.researchprotocols.org/2021/11/e31307 UR - http://dx.doi.org/10.2196/31307 UR - http://www.ncbi.nlm.nih.gov/pubmed/34842549 ID - info:doi/10.2196/31307 ER - TY - JOUR AU - Horvath, Mark AU - Grutman, Aurora AU - O'Malley, S. Stephanie AU - Gueorguieva, Ralitza AU - Khan, Nashmia AU - Brewer, A. Judson AU - Garrison, A. Kathleen PY - 2021/11/16 TI - Smartband-Based Automatic Smoking Detection and Real-time Mindfulness Intervention: Protocol for a Feasibility Trial JO - JMIR Res Protoc SP - e32521 VL - 10 IS - 11 KW - smartband KW - smartphone KW - smoking KW - mindfulness KW - craving KW - mHealth N2 - Background: Smoking is the leading cause of preventable death in the United States. Smoking cessation interventions delivered by smartphone apps are a promising tool for helping smokers quit. However, currently available smartphone apps for smoking cessation have not exploited their unique potential advantages to aid quitting. Notably, few to no available apps use wearable technologies, most apps require users to self-report their smoking, and few to no apps deliver treatment automatically contingent upon smoking. Objective: This pilot trial tests the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver brief mindfulness interventions in real time to reduce smoking. Methods: Daily smokers (N=100, ?5 cigarettes per day) wear a smartband for 60 days to monitor and detect smoking, notify them about their smoking events in real time, and deliver real-time brief mindfulness exercises triggered by detected smoking events or targeted at predicted smoking events. Smokers set a quit date at 30 days. A three-step intervention to reduce smoking is tested. First, participants wear a smartband to monitor and detect smoking, and notify them of smoking events in real time to bring awareness to smoking and triggers for 21 days. Next, a ?mindful smoking? exercise is triggered by detected smoking events to bring a clear recognition of the actual effects of smoking for 7 days. Finally, after their quit date, a ?RAIN? (recognize, allow, investigate, nonidentification) exercise is delivered to predicted smoking events (based on the initial 3 weeks of tracking smoking data) to help smokers learn to work mindfully with cravings rather than smoke for 30 days. The primary outcomes are feasibility measures of treatment fidelity, adherence, and acceptability. The secondary outcomes are smoking rates at end of treatment. Results: Recruitment for this trial started in May 2021 and will continue until November 2021 or until enrollment is completed. Data monitoring and management are ongoing for enrolled participants. The final 60-day end of treatment data is anticipated in January 2022. We expect that all trial results will be available in April 2022. Conclusions: Findings will provide data and information on the feasibility of using a smartband and smartphone to monitor and detect smoking and deliver real-time brief mindfulness interventions, and whether the intervention warrants additional testing for smoking cessation. Trial Registration: ClinicalTrials.gov NCT03995225; https://clinicaltrials.gov/ct2/show/NCT03995225 International Registered Report Identifier (IRRID): DERR1-10.2196/32521 UR - https://www.researchprotocols.org/2021/11/e32521 UR - http://dx.doi.org/10.2196/32521 UR - http://www.ncbi.nlm.nih.gov/pubmed/34783663 ID - info:doi/10.2196/32521 ER - TY - JOUR AU - Stecher, Chad AU - Berardi, Vincent AU - Fowers, Rylan AU - Christ, Jaclyn AU - Chung, Yunro AU - Huberty, Jennifer PY - 2021/11/4 TI - Identifying App-Based Meditation Habits and the Associated Mental Health Benefits: Longitudinal Observational Study JO - J Med Internet Res SP - e27282 VL - 23 IS - 11 KW - behavioral habits KW - habit formation KW - mindfulness meditation KW - mental health KW - mHealth KW - mobile health KW - dynamic time warping KW - mobile phone N2 - Background: Behavioral habits are often initiated by contextual cues that occur at approximately the same time each day; so, it may be possible to identify a reflexive habit based on the temporal similarity of repeated daily behavior. Mobile health tools provide the detailed, longitudinal data necessary for constructing such an indicator of reflexive habits, which can improve our understanding of habit formation and help design more effective mobile health interventions for promoting healthier habits. Objective: This study aims to use behavioral data from a commercial mindfulness meditation mobile phone app to construct an indicator of reflexive meditation habits based on temporal similarity and estimate the association between temporal similarity and meditation app users? perceived health benefits. Methods: App-use data from June 2019 to June 2020 were analyzed for 2771 paying subscribers of a meditation mobile phone app, of whom 86.06% (2359/2771) were female, 72.61% (2012/2771) were college educated, 86.29% (2391/2771) were White, and 60.71% (1664/2771) were employed full-time. Participants volunteered to complete a survey assessing their perceived changes in physical and mental health from using the app. Receiver operating characteristic curve analysis was used to evaluate the ability of the temporal similarity measure to predict future behavior, and variable importance statistics from random forest models were used to corroborate these findings. Logistic regression was used to estimate the association between temporal similarity and self-reported physical and mental health benefits. Results: The temporal similarity of users? daily app use before completing the survey, as measured by the dynamic time warping (DTW) distance between app use on consecutive days, significantly predicted app use at 28 days and at 6 months after the survey, even after controlling for users? demographic and socioeconomic characteristics, total app sessions, duration of app use, and number of days with any app use. In addition, the temporal similarity measure significantly increased in the area under the receiver operating characteristic curve (AUC) for models predicting any future app use in 28 days (AUC=0.868 with DTW and 0.850 without DTW; P<.001) and for models predicting any app use in 6 months (AUC=0.821 with DTW and 0.802 without DTW; P<.001). Finally, a 1% increase in the temporal similarity of users? daily meditation practice with the app over 6 weeks before the survey was associated with increased odds of reporting mental health improvements, with an odds ratio of 2.94 (95% CI 1.832-6.369). Conclusions: The temporal similarity of the meditation app use was a significant predictor of future behavior, which suggests that this measure can identify reflexive meditation habits. In addition, temporal similarity was associated with greater perceived mental health benefits, which demonstrates that additional mental health benefits may be derived from forming reflexive meditation habits. UR - https://www.jmir.org/2021/11/e27282 UR - http://dx.doi.org/10.2196/27282 UR - http://www.ncbi.nlm.nih.gov/pubmed/34734826 ID - info:doi/10.2196/27282 ER - TY - JOUR AU - Mathur, Mala AU - Kerr, R. Bradley AU - Babal, C. Jessica AU - Eickhoff, C. Jens AU - Coller, J. Ryan AU - Moreno, A. Megan PY - 2021/11/2 TI - US Parents? Acceptance of Learning About Mindfulness Practices for Parents and Children: National Cross-sectional Survey JO - JMIR Pediatr Parent SP - e30242 VL - 4 IS - 4 KW - mindfulness KW - mental health KW - general pediatrics KW - pediatrics KW - children KW - parents KW - acceptability KW - well-being KW - parenting N2 - Background: Mindfulness practices are associated with improved health and well-being for children. Few studies have assessed parents? acceptance of learning about mindfulness practices. Objective: This study aims to assess parents? beliefs and interest in learning about mindfulness, including from their health care provider, and differences across demographic backgrounds. Methods: We conducted a national cross-sectional survey of parents with children aged 0-18 years in October 2018. Measures included beliefs and interest in learning about mindfulness. These measures were compared across demographic backgrounds using chi-square analysis. Multivariate linear and logistic regression analyses were used to perform adjusted comparisons between demographic backgrounds. Results: Participants (N=3000) were 87% (n=2621) female and 82.5% (n=2466) Caucasian. Most (n=1913, 64.2%) reported beliefs that mindfulness can be beneficial when parenting, 56.4% (n=1595) showed interest in learning about mindfulness to help their child stay healthy, and 40.8% (n=1214) reported interest in learning about mindfulness from their health care provider. Parents with a college degree 49.6% (n=444) were more likely to report interest in learning about mindfulness from a health care provider compared to those without 37.1% (n=768; P<.001). Parents interested in learning about mindfulness were more likely to be male 62.6% (n=223; P<.001). There was no significant difference in interest in learning about mindfulness from a health care provider based on race. Conclusions: This study indicates that many parents believe mindfulness can be beneficial while parenting and are interested in learning how mindfulness could help their child stay healthy. Findings suggest there is an opportunity to educate families about mindfulness practices. UR - https://pediatrics.jmir.org/2021/4/e30242 UR - http://dx.doi.org/10.2196/30242 UR - http://www.ncbi.nlm.nih.gov/pubmed/34726605 ID - info:doi/10.2196/30242 ER - TY - JOUR AU - Smith, L. Jeremy AU - Allen, W. Jason AU - Haack, I. Carla AU - Wehrmeyer, L. Kathryn AU - Alden, G. Kayley AU - Lund, B. Maha AU - Mascaro, S. Jennifer PY - 2021/10/19 TI - Impact of App-Delivered Mindfulness Meditation on Functional Connectivity, Mental Health, and Sleep Disturbances Among Physician Assistant Students: Randomized, Wait-list Controlled Pilot Study JO - JMIR Form Res SP - e24208 VL - 5 IS - 10 KW - mindfulness KW - meditation KW - resting state KW - fMRI KW - connectivity KW - mobile phone N2 - Background: Health care provider and trainee burnout results in substantial national and institutional costs and profound social effects. Identifying effective solutions and interventions to cultivate resilience among health care trainees is critical. Although less is known about the mental health needs of physician assistants (PAs) or PA students, accumulating research indicates that they experience similarly alarming rates of burnout, depression, and emotional exhaustion. Mobile app?delivered mindfulness meditation may be an effective part of salubrious programming to bolster long-term resilience and health among PA students. Objective: This study aims to examine the impact of app-delivered mindfulness meditation on self-reported mental health symptoms among PA students. A secondary aim is to investigate changes in brain connectivity to identify neurobiological changes related to changes in mental health symptoms. Methods: We recruited PA students enrolled in their third semester of PA school and used a longitudinal, randomized, wait-list?controlled design. Participants randomized to the mindfulness group were provided 1-year subscriptions to the 10% Happier app, a consumer-based meditation app, and asked to practice every day for 8 weeks. Before randomization and again after completion of the 8-week program, all participants completed resting-state functional magnetic resonance imaging as well as self-report assessments of burnout, depression, anxiety, and sleep impairment. App use was acquired as a measure of mindfulness practice time. Results: PA students randomized to the mindfulness group reported improvements in sleep impairment compared with those randomized to the wait-list control group (?p2=0.42; P=.01). Sleep impairment decreased significantly in the mindfulness group (19% reduction; P=.006) but not in the control group (1% reduction; P=.71). There were no other significant changes in mental health for those randomized to app-delivered mindfulness. Across all students, changes in sleep impairment were associated with increased resting-state functional connectivity between the medial prefrontal cortex (a component of the default mode network) and the superior temporal gyrus, as well as between areas important for working memory. Changes in connectivity predicted categorical conversion from impaired to nonimpaired sleep in the mindfulness group. Conclusions: This pilot study is the first to examine app-based mindfulness for PA students? mental health and investigate the impact of mindfulness on PA students? brain function. These findings suggest that app-delivered mindfulness may be an effective tool to improve sleep dysfunction and that it may be an important part of the programming necessary to reduce the epidemic of suffering among health profession trainees. UR - https://formative.jmir.org/2021/10/e24208 UR - http://dx.doi.org/10.2196/24208 UR - http://www.ncbi.nlm.nih.gov/pubmed/34665153 ID - info:doi/10.2196/24208 ER - TY - JOUR AU - Rodriguez, Marcus AU - Eisenlohr-Moul, A. Tory AU - Weisman, Jared AU - Rosenthal, Zachary M. PY - 2021/10/13 TI - The Use of Task Shifting to Improve Treatment Engagement in an Internet-Based Mindfulness Intervention Among Chinese University Students: Randomized Controlled Trial JO - JMIR Form Res SP - e25772 VL - 5 IS - 10 KW - mindfulness KW - mental health KW - social support KW - internet-based intervention KW - treatment outcome KW - university students KW - smartphone KW - mobile phone N2 - Background: Traditional in-person psychotherapies are incapable of addressing global mental health needs. Use of computer-based interventions is one promising solution for closing the gap between the amount of global mental health treatment needed and received. Objective: Although many meta-analyses have provided evidence supporting the efficacy of self-guided, computer-based interventions, most report low rates of treatment engagement (eg, high attrition and low adherence). The aim of this study is to investigate the efficacy of an adjunctive treatment component that uses task shifting, wherein mental health care is provided by nonspecialist peer counselors to enhance engagement in an internet-based, self-directed, evidence-based mindfulness intervention among Chinese university students. Methods: From 3 universities across China, 54 students who reported at least mild stress, anxiety, or depression were randomly assigned to a 4-week internet-based mindfulness intervention (MIND) or to the intervention plus peer counselor support (MIND+), respectively. Be Mindful delivers all the elements of mindfulness-based cognitive therapy in an internet-based, 4-week course. Participants completed daily monitoring of mindfulness practice and mood, as well as baseline and posttreatment self-reported levels of depression, anxiety, stress, and trait mindfulness. We screened 56 volunteer peer counselor candidates who had no former training in the delivery of mental health services. Of these, 10 were invited to participate in a day-long training, and 4 were selected. Peer counselors were instructed to provide 6 brief (15-20 minute) sessions each week, to help encouraging participants to complete the internet-based intervention. Peer counselors received weekly web-based group supervision. Results: For both conditions, participation in the internet-based intervention was associated with significant improvements in mindfulness and mental health outcomes. The pre-post effect sizes (Cohen d) for mindfulness, depression, anxiety, and stress were 0.55, 0.95, 0.89, and 1.13, respectively. Participants assigned to the MIND+ (vs MIND) condition demonstrated significantly less attrition and more adherence, as indicated by a greater likelihood of completing posttreatment assessments (16/27, 59% vs 7/27, 26%; ?21=6.1; P=.01) and a higher percentage of course completion (72.6/100, 72.6% vs 50.7/100, 50.7%; t52=2.10; P=.04), respectively. No significant between-group differences in daily frequency and duration of mindfulness practice were observed. Multilevel logistic growth models showed that MIND+ participants reported significantly greater pre-post improvements in daily stress ratings (interaction estimate 0.39, SE 0.18; t317=2.29; P=.02) and depression (interaction estimate 0.38, SE 0.16; t330=2.37; P=.02) than those in the MIND condition. Conclusions: This study provides new insights into effective ways of leveraging technology and task shifting to implement large-scale mental health initiatives that are financially feasible, easily transportable, and quickly scalable in low-resource settings. The findings suggest that volunteer peer counselors receiving low-cost, low-intensity training and supervision may significantly improve participants? indices of treatment engagement and mental health outcomes in an internet-based mindfulness intervention among Chinese university students. UR - https://formative.jmir.org/2021/10/e25772 UR - http://dx.doi.org/10.2196/25772 UR - http://www.ncbi.nlm.nih.gov/pubmed/34643532 ID - info:doi/10.2196/25772 ER - TY - JOUR AU - Hu, Xiao-Su AU - Beard, Katherine AU - Sherbel, Catherine Mary AU - Nascimento, D. Thiago AU - Petty, Sean AU - Pantzlaff, Eddie AU - Schwitzer, David AU - Kaciroti, Niko AU - Maslowski, Eric AU - Ashman, M. Lawrence AU - Feinberg, E. Stephen AU - DaSilva, F. Alexandre PY - 2021/10/12 TI - Brain Mechanisms of Virtual Reality Breathing Versus Traditional Mindful Breathing in Pain Modulation: Observational Functional Near-infrared Spectroscopy Study JO - J Med Internet Res SP - e27298 VL - 23 IS - 10 KW - virtual reality breathing KW - traditional mindful breathing KW - pain KW - functional near-infrared spectroscopy KW - mobile phone N2 - Background: Pain is a complex experience that involves sensory-discriminative and cognitive-emotional neuronal processes. It has long been known across cultures that pain can be relieved by mindful breathing (MB). There is a common assumption that MB exerts its analgesic effect through interoception. Interoception refers to consciously refocusing the mind?s attention to the physical sensation of internal organ function. Objective: In this study, we dissect the cortical analgesic processes by imaging the brains of healthy subjects exposed to traditional MB (TMB) and compare them with another group for which we augmented MB to an outside sensory experience via virtual reality breathing (VRB). Methods: The VRB protocol involved in-house?developed virtual reality 3D lungs that synchronized with the participants? breathing cycles in real time, providing them with an immersive visual-auditory exteroception of their breathing. Results: We found that both breathing interventions led to a significant increase in pain thresholds after week-long practices, as measured by a thermal quantitative sensory test. However, the underlying analgesic brain mechanisms were opposite, as revealed by functional near-infrared spectroscopy data. In the TMB practice, the anterior prefrontal cortex uniquely modulated the premotor cortex. This increased its functional connection with the primary somatosensory cortex (S1), thereby facilitating the S1-based sensory-interoceptive processing of breathing but inhibiting its other role in sensory-discriminative pain processing. In contrast, virtual reality induced an immersive 3D exteroception with augmented visual-auditory cortical activations, which diminished the functional connection with the S1 and consequently weakened the pain processing function of the S1. Conclusions: In summary, our study suggested two analgesic neuromechanisms of VRB and TMB practices?exteroception and interoception?that distinctively modulated the S1 processing of the ascending noxious inputs. This is in line with the concept of dualism (Yin and Yang). UR - https://www.jmir.org/2021/10/e27298 UR - http://dx.doi.org/10.2196/27298 UR - http://www.ncbi.nlm.nih.gov/pubmed/34636731 ID - info:doi/10.2196/27298 ER - TY - JOUR AU - Watt, Makayla AU - Spence, C. John AU - Tandon, Puneeta PY - 2021/10/8 TI - Development of a Theoretically Informed Web-Based Mind-Body Wellness Intervention for Patients With Primary Biliary Cholangitis: Formative Study JO - JMIR Form Res SP - e29064 VL - 5 IS - 10 KW - liver disease KW - meditation KW - yoga KW - breathwork KW - behavior theory KW - COM-B model KW - behaviour change wheel KW - behaviour change taxonomy KW - internet KW - digital N2 - Background: Mind-body interventions have the potential to positively impact the symptom burden associated with primary biliary cholangitis (PBC). Interventions are more likely to be effective if they are informed by a theoretical framework. The Behaviour Change Wheel (BCW) and the behaviour change technique taxonomy version 1 (BCTv1) provide frameworks for intervention development. Objective: This study describes how theory has guided the development of a 12-week multicomponent mind-body wellness intervention for PBC. Methods: The steps involved in developing the BCW intervention included specifying the target behavior; explaining barriers and facilitators using the Capability, Opportunity, Motivation, and Behaviour and the theoretical domains framework; identifying intervention functions to target explanatory domains; and selecting relevant behavior change techniques to address intervention functions. Qualitative data from patients with inflammatory bowel disease using an earlier version of the program and feedback from a PBC patient advisory team were used to guide intervention development. Results: Barriers and facilitators to intervention participation associated with capability, opportunity, and motivation were identified. Intervention functions and behavior change techniques were identified to target each barrier and facilitator. Conclusions: The Peace Power Pack PBC intervention was developed to help individuals with PBC manage their symptom burden. The theoretical frameworks employed in this intervention provide direction on targeting antecedents of behavior and allow standardized reporting of intervention components. Trial Registration: ClinicalTrials.gov NCT04791527; https://clinicaltrials.gov/ct2/show/NCT04791527 UR - https://formative.jmir.org/2021/10/e29064 UR - http://dx.doi.org/10.2196/29064 UR - http://www.ncbi.nlm.nih.gov/pubmed/34623317 ID - info:doi/10.2196/29064 ER - TY - JOUR AU - Martorella, Geraldine AU - Hanley, W. Adam AU - Pickett, M. Scott AU - Gelinas, Céline PY - 2021/8/30 TI - Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e30951 VL - 10 IS - 8 KW - postoperative pain KW - cardiac surgery KW - chronic pain KW - web-based KW - mindfulness KW - mobile phone N2 - Background: Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined. Objective: The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery. Methods: A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ?18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ?4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University?s Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board. Results: Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic. Conclusions: This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/30951 UR - https://www.researchprotocols.org/2021/8/e30951 UR - http://dx.doi.org/10.2196/30951 UR - http://www.ncbi.nlm.nih.gov/pubmed/34459749 ID - info:doi/10.2196/30951 ER - TY - JOUR AU - O'Loughlin, Patricia AU - Pavithra, Pavithra AU - Regan, John AU - Bennett, Marc AU - Knight, Rachel AU - Lenaert, Bert AU - Marquez, Melissa AU - Taddeo, Michelle AU - Griffith, James AU - Shapiro, Rita AU - Farina, Francesca PY - 2021/7/30 TI - A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study JO - JMIR Res Protoc SP - e30514 VL - 10 IS - 7 KW - fear KW - memory loss KW - dementia KW - older adults KW - mindfulness KW - behavioral activation N2 - Background: Dementia is the most feared disease associated with aging. Prolonged fears about memory loss and dementia can have harmful consequences even in the absence of cognitive decline. Fear of dementia is associated with poorer health outcomes and psychological well-being and increased memory failures in older adults. Objective: We will conduct a randomized controlled trial to determine the feasibility of a tailored, web-based mindfulness program to reduce fear of memory loss and increase quality of life in older adults experiencing heightened fear. Methods: Eighty participants will be recruited and divided into 2 groups (40 in each group). One group will receive psychoeducation plus mindfulness training. A second group will receive psychoeducation, mindfulness training, and additional modules targeting maladaptive behavioral avoidance (ie, social and cognitive withdrawal). Results: Our recent etiological model posits that maladaptive behavioral avoidance strategies critically underlie psychosocial dysfunction associated with fear of memory loss. Thus, we predict better outcomes in the second group, including reduced fear of memory loss (primary outcome), Alzheimer disease, anxiety, and subjective memory failures, and increased quality of life (secondary outcomes). Outcome measures will be applied at 5 time points (before, baseline, interim, and after the intervention, and at 3-month follow-up). Data will be analyzed using mixed models and correlations. Conclusions: Results from this study will contribute to the current literature on dementia-related fear and improve our understanding of how to effectively address and reduce these fears. Trial Registration: ClinicalTrials.gov NCT04821960; https://clinicaltrials.gov/ct2/show/NCT04821960. International Registered Report Identifier (IRRID): PRR1-10.2196/30514 UR - https://www.researchprotocols.org/2021/7/e30514 UR - http://dx.doi.org/10.2196/30514 UR - http://www.ncbi.nlm.nih.gov/pubmed/34328428 ID - info:doi/10.2196/30514 ER - TY - JOUR AU - Mhende, Josephine AU - Bell, A. Sharrill AU - Cottrell-Daniels, Cherell AU - Luong, Jackie AU - Streiff, Micah AU - Dannenfelser, Mark AU - Hayat, J. Matthew AU - Spears, Adams Claire PY - 2021/7/23 TI - Mobile Delivery of Mindfulness-Based Smoking Cessation Treatment Among Low-Income Adults During the COVID-19 Pandemic: Pilot Randomized Controlled Trial JO - JMIR Form Res SP - e25926 VL - 5 IS - 7 KW - acceptability KW - addiction KW - African American KW - cessation KW - COVID-19 KW - feasibility KW - income KW - low socioeconomic status KW - mHealth KW - mindfulness KW - minority KW - smoking KW - SMS KW - text messaging KW - treatment N2 - Background: Smoking is the leading cause of premature death, and low-income adults experience disproportionate burden from tobacco. Mindfulness interventions show promise for improving smoking cessation. A text messaging program ?iQuit Mindfully? was developed to deliver just-in-time support for quitting smoking among low-income adults. A pilot study of iQuit Mindfully was conducted in spring 2020, during the COVID-19 pandemic, among low-income and predominantly African American smokers. Objective: This pilot study examined the acceptability and feasibility of delivering Mindfulness-Based Addiction Treatment via mHealth during the COVID-19 pandemic. Methods: Participants were adult cigarette smokers (n=23), of whom 8 (34.8%) were female, 19 (82.6%) were African American, and 18 (78.3%) had an annual income of .39). First responders who had tested positive and those who had been quarantined were more likely to engage in the program. A click count analysis per module showed that participants used the self-efficacy and mindfulness modules most often, with 382 and 122 clicks, respectively, over 15 weeks. Overall, first responders expressed satisfaction with the program. Conclusions: Engagement of first responders in the multimodule web-based COAST program was feasible and the first responder cohort expressed overall satisfaction with the program. Those in more difficult circumstances, including those in quarantine and those who tested positive, may be more likely to engage in such programs. Further controlled studies could pave the way for efficacy studies and the development of additional modules, including just-in-time interventions or blended interventions combining individual use of an unguided self-help intervention, such as COAST, with subsequent individual psychotherapy for those who continue to experience stress and psychological symptoms. UR - https://formative.jmir.org/2021/6/e28055 UR - http://dx.doi.org/10.2196/28055 UR - http://www.ncbi.nlm.nih.gov/pubmed/33999835 ID - info:doi/10.2196/28055 ER - TY - JOUR AU - Bhuiyan, Nishat AU - Puzia, Megan AU - Stecher, Chad AU - Huberty, Jennifer PY - 2021/5/26 TI - Associations Between Rural or Urban Status, Health Outcomes and Behaviors, and COVID-19 Perceptions Among Meditation App Users: Longitudinal Survey Study JO - JMIR Mhealth Uhealth SP - e26037 VL - 9 IS - 5 KW - mHealth KW - rural health KW - physical activity KW - mental health KW - COVID-19 N2 - Background: Rural and urban differences in health outcomes and behaviors have been well-documented, with significant rural health disparities frequently highlighted. Mobile health (mHealth) apps, such as meditation apps, are a novel method for improving health and behaviors. These apps may be a critical health promotion strategy during the COVID-19 pandemic and could potentially be used to address rural health disparities. However, limited research has assessed whether meditation app health outcomes are associated with rural and urban residence, and it is unclear whether disparities in health and behaviors between rural and urban populations would persist among meditation app users. Objective: We aimed to explore associations between rural or urban status, psychological outcomes, and physical activity among users of a mobile meditation app. We further aimed to explore associations between rural or urban status and perceived effects of COVID-19 on stress, mental health, and physical activity, and to explore changes in these outcomes in rural versus urban app users over time. Methods: This study was a secondary analysis of a national survey conducted among subscribers to the meditation app Calm. Eligible participants completed online baseline surveys from April to June 2020, and follow-up surveys from June to September 2020, assessing demographics, psychological outcomes, physical activity, and perceived effects of COVID-19 on stress, mental health, and physical activity. Results: Participants (N=8392) were mostly female (7041/8392, 83.9%), non-Hispanic (7855/8392, 93.6%), and White (7704/8392, 91.8%); had high socioeconomic status (income ?US $100,000: 4389/8392, 52.3%; bachelor?s degree or higher: 7251/8392, 86.4%); and resided in a metropolitan area core (rural-urban commuting area code 1: 7192/8392, 85.7%). Rural or urban status was not associated with baseline stress, depression, anxiety, pre?COVID-19 and current physical activity, or perceived effects of COVID-19 on stress, mental health, and physical activity. Repeated-measures models showed overall decreases in depression, anxiety, and perceived effects of COVID-19 on physical activity from baseline to follow-up, and no significant changes in stress or perceived effects of COVID-19 on stress and mental health over time. Models also showed no significant main effects of rural or urban status, COVID-19 statewide prevalence at baseline, or change in COVID-19 statewide prevalence. Conclusions: We did not find associations between rural or urban status and psychological outcomes (ie, stress, depression, and anxiety), physical activity, or perceived effects of COVID-19 on stress, mental health, and physical activity. Rural or urban status does not appear to drive differences in outcomes among meditation app users, and the use of mHealth apps should continue to be explored as a health promotion strategy in both rural and urban populations. Furthermore, our results did not show negative cumulative effects of COVID-19 on psychological outcomes and physical activity among app users in our sample, the majority of whom were urban, White, female, and of high socioeconomic status. Further research is needed to investigate meditation app use as a health promotion strategy in rural and urban populations. UR - https://mhealth.jmir.org/2021/5/e26037 UR - http://dx.doi.org/10.2196/26037 UR - http://www.ncbi.nlm.nih.gov/pubmed/33900930 ID - info:doi/10.2196/26037 ER - TY - JOUR AU - Dunham, Michael C. AU - Burger, J. Amanda AU - Hileman, M. Barbara AU - Chance, A. Elisha AU - Hutchinson, E. Amy PY - 2021/5/26 TI - Bispectral Index Alterations and Associations With Autonomic Changes During Hypnosis in Trauma Center Researchers: Formative Evaluation Study JO - JMIR Form Res SP - e24044 VL - 5 IS - 5 KW - bispectral index KW - hypnosis KW - heart rate variability KW - electromyography KW - skin conductance KW - skin temperature KW - respiratory rate KW - expired carbon dioxide KW - neurofeedback N2 - Background: Previous work performed by our group demonstrated that intermittent reductions in bispectral index (BIS) values were found during neurofeedback following mindfulness instructions. Hypnosis was induced to enhance reductions in BIS values. Objective: This study aims to assess physiologic relaxation and explore its associations with BIS values using autonomic monitoring. Methods: Each session consisted of reading a 4-minute baseline neutral script and playing an 18-minute hypnosis tape to 3 researchers involved in the BIS neurofeedback study. In addition to BIS monitoring, autonomic monitoring was performed, and this included measures of electromyography (EMG), skin temperature, skin conductance, respiratory rate, expired carbon dioxide, and heart rate variability. The resulting data were analyzed using two-tailed t tests, correlation analyses, and multivariate linear regression analyses. Results: We found that hypnosis was associated with reductions in BIS (P<.001), EMG (P<.001), respiratory rate (P<.001), skin conductance (P=.006), and very low frequency power (P=.04); it was also associated with increases in expired carbon dioxide (P<.001), skin temperature (P=.04), high frequency power (P<.001), and successive heart interbeat interval difference (P=.04) values. Decreased BIS values were associated with reduced EMG measures (R=0.76; P<.001), respiratory rate (R=0.35; P=.004), skin conductance (R=0.57; P<.001), and low frequency power (R=0.32; P=.01) and with increased high frequency power (R=?0.53; P<.001), successive heart interbeat interval difference (R=?0.32; P=.009), and heart interbeat interval SD (R=?0.26; P=.04) values. Conclusions: Hypnosis appeared to induce mental and physical relaxation, enhance parasympathetic neural activation, and attenuate sympathetic nervous system activity, changes that were associated with BIS values. Findings from this preliminary formative evaluation suggest that the current hypnosis model may be useful for assessing autonomic physiological associations with changes in BIS values, thus motivating us to proceed with a larger investigation in trauma center nurses and physicians. UR - https://formative.jmir.org/2021/5/e24044 UR - http://dx.doi.org/10.2196/24044 UR - http://www.ncbi.nlm.nih.gov/pubmed/34037529 ID - info:doi/10.2196/24044 ER - TY - JOUR AU - Venkatesan, Aarathi AU - Krymis, Holly AU - Scharff, Jenny AU - Waber, Art PY - 2021/5/25 TI - Changes in Perceived Stress Following a 10-Week Digital Mindfulness-Based Stress Reduction Program: Retrospective Study JO - JMIR Form Res SP - e25078 VL - 5 IS - 5 KW - perceived stress KW - health coaching KW - digital mental health intervention KW - digital therapeutics KW - mobile phone N2 - Background: As the need for effective scalable interventions for mental health conditions such as depression, anxiety, and stress has grown, the digital delivery of mindfulness-based stress reduction (MBSR) has gained interest as a promising intervention in this domain. Objective: This study aims to evaluate the changes in perceived stress following a 10-week digital MBSR program that combined an app-based digital program with weekly one-on-one remote sessions with a health coach. Methods: This study used a retrospective, observational design. A total of 229 participants with moderate-to-high perceived stress scores as assessed by the Perceived Stress Scale (PSS)-10 enrolled in the 10-week Vida Health MBSR program. The program included weekly remote sessions with a certified health coach and digital content based on concepts fundamental to mindfulness practice. The PSS-10 was used to evaluate perceived stress. Of the 229 participants, 131 (57.2%) were considered program completers and provided at least one follow-up PSS-10. A secondary analysis examined the changes in stress scores at 6 months. This analysis was restricted to participants who had been enrolled in the program for at least 6 months (n=121). To account for random and fixed effects, linear mixed effects modeling was used to assess changes in stress scores over time. An intention-to-treat approach was used to evaluate the changes in perceived stress across the entire study cohort, including those who were lost to follow-up. In addition, a reliable change index was computed to evaluate the changes in scores from the baseline. Results: The findings revealed a significant positive association between program time and stress reduction (B=?0.365; P<.001) at 12 weeks. We observed an average reduction in stress scores of 3.17 points (95% CI ?3.93 to ?2.44) by program week 6 and 4.86 points (95% CI ?5.86 to ?3.85) by program week 12. Overall, 83.2% (109/131) of participants showed a reduction in stress scores by week 12, with 40.5% (53/131) of participants showing reliable improvement at 12 weeks and 47.8% (56/131) of participants showing a shift to a lower stress level category (ie, moderate-to-low stress). The intention-to-treat analysis revealed a significant, although attenuated, reduction in stress scores at 12 weeks (B=?0.23; P<.001). Participants who completed more lessons had an increased likelihood of moving down at least one stress level category (odds ratio 1.512, 95% CI 1.056 to 2.166; P=.02). In assessing medium-term outcomes, among participants who had completed at least 6 months in the program, 48.8% (59/121) of members provided a 6-month assessment. We observed a significant reduction in stress scores at 6 months (t58=10.24; P<.001), with 61% (36/59) of participants showing reliable improvement. Conclusions: The findings of this retrospective, observational study suggest that a blended, digital mindfulness-based intervention may support program uptake and meaningful, sustained reduction in stress outcomes. UR - https://formative.jmir.org/2021/5/e25078 UR - http://dx.doi.org/10.2196/25078 UR - http://www.ncbi.nlm.nih.gov/pubmed/34032571 ID - info:doi/10.2196/25078 ER - TY - JOUR AU - Fiol-DeRoque, Antònia Maria AU - Serrano-Ripoll, Jesús Maria AU - Jiménez, Rafael AU - Zamanillo-Campos, Rocío AU - Yáñez-Juan, María Aina AU - Bennasar-Veny, Miquel AU - Leiva, Alfonso AU - Gervilla, Elena AU - García-Buades, Esther M. AU - García-Toro, Mauro AU - Alonso-Coello, Pablo AU - Pastor-Moreno, Guadalupe AU - Ruiz-Pérez, Isabel AU - Sitges, Carolina AU - García-Campayo, Javier AU - Llobera-Cánaves, Joan AU - Ricci-Cabello, Ignacio PY - 2021/5/18 TI - A Mobile Phone?Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e27039 VL - 9 IS - 5 KW - COVID-19 KW - randomized controlled trial KW - mental health KW - health care workers KW - mHealth KW - app N2 - Background: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. Objective: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. Methods: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. Results: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference ?0.04; 95% CI ?0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (?0.29; 95% CI ?0.48 to ?0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (?0.25; 95% CI ?0.49 to ?0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. Conclusions: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. Trial Registration: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818. UR - https://mhealth.jmir.org/2021/5/e27039 UR - http://dx.doi.org/10.2196/27039 UR - http://www.ncbi.nlm.nih.gov/pubmed/33909587 ID - info:doi/10.2196/27039 ER - TY - JOUR AU - Huberty, Jennifer AU - Green, Jeni AU - Puzia, Megan AU - Stecher, Chad PY - 2021/4/23 TI - Evaluation of Mood Check-in Feature for Participation in Meditation Mobile App Users: Retrospective Longitudinal Analysis JO - JMIR Mhealth Uhealth SP - e27106 VL - 9 IS - 4 KW - adherence KW - meditation KW - mindfulness KW - mood KW - smartphone application KW - app KW - engagement KW - mHealth KW - mental health KW - behavior N2 - Background: Mindfulness meditation smartphone apps may improve mental health but lack evidence-based behavioral strategies to encourage their regular use for attaining mental health benefits. In October 2019, the Calm mindfulness meditation app introduced a mood check-in feature, but its effects on participation in meditation have yet to be tested. Objective: The objective of this study was to investigate how a mood check-in feature impacts meditation behavior in Calm app subscribers. Methods: This was a retrospective longitudinal analysis of mobile app usage data from a random sample of first-time subscribers to the Calm app (n=2600) who joined in summer 2018 or summer 2019. The mood check-in feature allows users to rate their mood using an emoji after completing a meditation session and displays a monthly calendar of their past mood check-ins. Regression analyses were used to compare the rate of change in meditation behavior before and after the introduction of mood check-ins and to estimate how usage of mood check-ins was associated with individuals? future meditation behavior (ie, intent-to-treat effects). Additional regression models examined the heterogenous effect of mood check-ins between subscribers who were active or inactive users prior to the introduction to mood check-ins (ie, above or below the median number of weeks with any meditation within their cohort). In order to confirm the specific associations between mood check-ins and meditation engagement, we modeled the direct relationship between the use of mood check-ins in previous weeks and subsequent meditation behavior (ie, treatment on the treated effects). Results: During the first 9 months of their subscription, the 2019 cohort completed an average of 0.482 more sessions per week (95% CI 0.309 to 0.655) than the 2018 cohort; however, across both cohorts, average weekly meditation declined (?0.033 sessions per week, 95% CI ?0.035 to ?0.031). Controlled for trends in meditation before mood check-ins and aggregate differences between the 2018 and 2019 samples, the time trend in the number of weekly meditation sessions increased by 0.045 sessions among the 2019 cohort after the introduction of mood check-ins (95% CI 0.039 to 0.052). This increase in meditation was most pronounced among the inactive subscribers (0.063 sessions, 95% CI 0.052 to 0.074). When controlled for past-week meditation, use of mood check-ins during the previous week was positively associated with the likelihood of meditating the following week (odds ratio 1.132, 95% CI 1.059 to 1.211); however, these associations were not sustained beyond 1 week. Conclusions: Using mood check-ins increases meditation participation in Calm app subscribers and may be especially beneficial for inactive subscribers. Mobile apps should consider incorporating mood check-ins to help better engage a wider range of users in app-based meditation, but more research is warranted. UR - https://mhealth.jmir.org/2021/4/e27106 UR - http://dx.doi.org/10.2196/27106 UR - http://www.ncbi.nlm.nih.gov/pubmed/33890865 ID - info:doi/10.2196/27106 ER - TY - JOUR AU - Green, Jennifer AU - Huberty, Jennifer AU - Puzia, Megan AU - Stecher, Chad PY - 2021/4/13 TI - The Effect of Meditation and Physical Activity on the Mental Health Impact of COVID-19?Related Stress and Attention to News Among Mobile App Users in the United States: Cross-sectional Survey JO - JMIR Ment Health SP - e28479 VL - 8 IS - 4 KW - coronavirus KW - health behavior KW - mindfulness meditation KW - mHealth KW - COVID-19 KW - mental health N2 - Background: The COVID-19 pandemic has been declared an international public health emergency, and it may have long-lasting effects on people?s mental health. There is a need to identify effective health behaviors to mitigate the negative mental health impact of COVID-19. Objective: The objectives of this study were to (1) examine the regional differences in mental health and COVID-19?related worry, attention to news, and stress, in light of the state-level prevalence of COVID-19 cases; (2) estimate the associations between mental health and COVID-19?related worry, attention to news, and stress and health behavior engagement (ie, physical activity, mindfulness meditation); and (3) explore the mediating effect of health behavior engagement on the associations between mental health and COVID-19?related worry, attention to news, and stress. Methods: A cross-sectional survey was distributed to a sample of US adult paying subscribers to the Calm app (data were collected from April 22 to June 3, 2020). The survey assessed COVID-19?related worry, attention to news, and stress; health behavior engagement; and mental health (ie, perceived stress, posttraumatic stress disorder, and anxiety and depression). Statistical analyses were performed using R software. Differences in COVID-19?related worry, attention to news, and stress and mental health by location were assessed using t tests and chi-square tests. Logistic and ordinary least squares models were used to regress mental health and health behavior on COVID-19?related worry, attention to news, and stress; moreover, causal mediation analysis was used to estimate the significance of the mediation effects. Results: The median age of the respondents (N=8392) was 47 years (SD 13.8). Participants in the Mid-Atlantic region (New Jersey, New York, and Pennsylvania) reported higher levels of stress, more severe depression symptoms, greater worry about COVID-19, paying more attention to COVID-19?related news, and more stress related to social distancing recommendations than participants living in other regions. The association between worry about COVID-19 and perceived stress was significantly mediated by changes in physical activity (P<.001), strength of meditation habit (P<.001), and stopping meditation (P=.046). The association between worry about COVID-19 and posttraumatic stress disorder symptoms was significantly mediated by changes in physical activity (P<.001) and strength of meditation habit (P<.001). Conclusions: Our findings describe the mental health impact of COVID-19 and outline how continued participation in health behaviors such as physical activity and mindfulness meditation reduce worsening of mental health due to the COVID-19 pandemic. These data have important implications for public health agencies and health organizations to promote the maintenance of health habits to reduce the residual mental health burden of the COVID-19 pandemic. UR - https://mental.jmir.org/2021/4/e28479 UR - http://dx.doi.org/10.2196/28479 UR - http://www.ncbi.nlm.nih.gov/pubmed/33788698 ID - info:doi/10.2196/28479 ER - TY - JOUR AU - Lim, Julian AU - Leow, Zaven AU - Ong, Jason AU - Pang, Ly-Shan AU - Lim, Eric PY - 2021/3/15 TI - Effects of Web-Based Group Mindfulness Training on Stress and Sleep Quality in Singapore During the COVID-19 Pandemic: Retrospective Equivalence Analysis JO - JMIR Ment Health SP - e21757 VL - 8 IS - 3 KW - mindfulness KW - COVID-19 KW - videoconference KW - perceived stress KW - sleep quality KW - intervention KW - telehealth KW - mental health KW - psychology N2 - Background: The COVID-19 pandemic has negatively impacted psychological health. Mindfulness training, which helps individuals attend to the present moment with a nonjudgmental attitude, improves sleep and reduces stress during regular times. Mindfulness training may also be relevant to the mitigation of harmful health consequences during acute crises. However, certain restrictions may necessitate the web-based delivery of mindfulness training (ie, rather than in-person group training settings). Objective: The objective of our study was to examine the effects of mindfulness interventions during the COVID-19 pandemic and to evaluate the effectiveness of web-based interventions. Methods: Data from an ongoing study were used for this retrospective equivalence analysis. Recruited participants were enrollees from mindfulness courses at a local charity organization that promoted mental wellness. This study had no exclusion criteria. We created three groups; two groups received their training during the COVID-19 pandemic (in-person training group: n=36; videoconferencing group: n=38), and a second control group included participants who were trained before the pandemic (n=86). Our primary outcomes were self-reported stress and sleep quality. Baseline levels and changes in these variables due to mindfulness training were compared among the groups via an analysis of covariance test and two one-tailed t tests. Results: Baseline perceived stress (P=.50) and sleep quality (P=.22) did not differ significantly among the three groups. Mindfulness training significantly reduced stress in all three groups (P<.001), and this effect was statistically significant when comparing videoconferencing to in-person training (P=.002). Sleep quality improved significantly in the prepandemic training group (P<.001). However, sleep quality did not improve in the groups that received training during the pandemic. Participants reported that they required shorter times to initiate sleep following prepandemic mindfulness training (P<.001), but this was not true for those who received training during the pandemic. Course attendance was high and equivalent across the videoconferencing and comparison groups (P=.02), and participants in the videoconferencing group engaged in marginally more daily practice than the in-person training group. Conclusions: Web-based mindfulness training via videoconferencing may be a useful intervention for reducing stress during times when traditional, in-person training is not feasible. However, it may not be useful for improving sleep quality. UR - https://mental.jmir.org/2021/3/e21757 UR - http://dx.doi.org/10.2196/21757 UR - http://www.ncbi.nlm.nih.gov/pubmed/33482627 ID - info:doi/10.2196/21757 ER - TY - JOUR AU - Ritvo, Paul AU - Knyahnytska, Yuliya AU - Pirbaglou, Meysam AU - Wang, Wei AU - Tomlinson, George AU - Zhao, Haoyu AU - Linklater, Renee AU - Bai, Shari AU - Kirk, Megan AU - Katz, Joel AU - Harber, Lillian AU - Daskalakis, Zafiris PY - 2021/3/10 TI - Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial JO - J Med Internet Res SP - e24380 VL - 23 IS - 3 KW - intervention study KW - telemedicine KW - electronic CBT KW - clinical trial KW - depression KW - cognitive behavioral therapy KW - CBT KW - online therapy KW - online intervention KW - youth KW - young adult N2 - Background: Approximately 70% of mental health disorders appear prior to 25 years of age and can become chronic when ineffectively treated. Individuals between 18 and 25 years old are significantly more likely to experience mental health disorders, substance dependencies, and suicidality. Treatment progress, capitalizing on the tendencies of youth to communicate online, can strategically address depressive disorders. Objective: We performed a randomized controlled trial (RCT) that compared online mindfulness-based cognitive behavioral therapy (CBT-M) combined with standard psychiatric care to standard psychiatric care alone in youth (18-30 years old) diagnosed with major depressive disorder. Methods: Forty-five participants were randomly assigned to CBT-M and standard care (n=22) or to standard psychiatric care alone (n=23). All participants were provided standard psychiatric care (ie, 1 session per month), while participants in the experimental group received an additional intervention consisting of the CBT-M online software program. Interaction with online workbooks was combined with navigation coaching delivered by phone and secure text messaging. Results: In a two-level linear mixed-effects model intention-to-treat analysis, significant between-group differences were found for the Beck Depression Inventory-II score (difference ?8.54, P=.01), Quick Inventory of Depressive Symptoms score (difference ?4.94, P=.001), Beck Anxiety Inventory score (difference ?11.29, P<.001), and Brief Pain Inventory score (difference ?1.99, P=.03), while marginal differences were found for the Five Facet Mindfulness Questionnaire?Nonjudging subscale (difference ?2.68, P=.05). Conclusions: These results confirm that youth depression can be effectively treated with online CBT-M that can be delivered with less geographic restriction. Trial Registration: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052 UR - https://www.jmir.org/2021/3/e24380 UR - http://dx.doi.org/10.2196/24380 UR - http://www.ncbi.nlm.nih.gov/pubmed/33688840 ID - info:doi/10.2196/24380 ER - TY - JOUR AU - Trottier, F. Claire AU - Lieffers, L. Jessica R. AU - Johnson, T. Steven AU - Mota, F. João AU - Gill, K. Roshni AU - Prado, M. Carla PY - 2021/3/10 TI - The Impact of a Web-Based Mindfulness, Nutrition, and Physical Activity Platform on the Health Status of First-Year University Students: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e24534 VL - 10 IS - 3 KW - internet-based intervention KW - wellness programs KW - dietary intake KW - physical activity KW - mindfulness KW - quality of life KW - randomized controlled trial N2 - Background: First-year university students are at an increased risk for developing mental health issues and a poor nutritional status. Self-care plays an essential role in optimizing mental health and can prevent or manage stress, anxiety, and depression. Web-based self-monitoring of diet and physical activity can lead to similar or improved health outcomes compared with conventional methods. Such tools are also popular among university students. Objective: The primary aim of this 12-week randomized controlled trial is to assess the impact of a web-based wellness platform on perceived stress among first-year university students. The secondary aim is to assess the effects of the platform on diet quality. The exploratory objectives are to explore the effects of the platform on body composition, health-related quality of life, mindfulness, mental well-being, and physical activity. Methods: A total of 97 first-year undergraduate students were randomized to either the intervention (n=48) or control (n=49) group. The intervention consisted of access to a web-based platform called My Viva Plan (MVP), which aims to support healthy living by focusing on the topics of mindfulness, nutrition, and physical activity. The platform is fully automated and guided by the principles of cognitive behavioral theory. Participants in the intervention group were instructed to use the MVP as frequently as possible over 12 weeks. The control group did not receive access to MVP. Perceived stress was assessed using the Stress Indicators Questionnaire at baseline, week 6, and week 12. Three-day food records were used to analyze the dietary intake at baseline and week 12. Health-related quality of life, mindfulness, mental well-being, and physical activity questionnaires were completed at baseline, week 6, and week 12. Body composition was assessed at baseline and week 12. Study assessments were completed in person at baseline and week 12 and electronically at week 6. Results: Study recruitment started in August 2018, with batch enrollment for students registered in the fall (September 2018 to December 2018) and winter (January 2019 to April 2019) academic terms at the University of Alberta, Edmonton, Alberta. Conclusions: This study is the first to explore the impact of a web-based platform designed to promote health and wellness on perceived stress and diet quality among first-year university students. Trial Registration: ClinicalTrials.gov NCT03579264; https://clinicaltrials.gov/ct2/show/NCT03579264. International Registered Report Identifier (IRRID): DERR1-10.2196/24534 UR - https://www.researchprotocols.org/2021/3/e24534 UR - http://dx.doi.org/10.2196/24534 UR - http://www.ncbi.nlm.nih.gov/pubmed/33688844 ID - info:doi/10.2196/24534 ER - TY - JOUR AU - Sesel, Amy-Lee AU - Sharpe, Louise AU - Beadnall, N. Heidi AU - Barnett, H. Michael AU - Szabo, Marianna AU - Naismith, L. Sharon PY - 2021/3/2 TI - Development of a Web-Based Mindfulness Program for People With Multiple Sclerosis: Qualitative Co-Design Study JO - J Med Internet Res SP - e19309 VL - 23 IS - 3 KW - multiple sclerosis KW - mindfulness KW - depression KW - program development KW - internet intervention KW - qualitative research N2 - Background: Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. Objective: This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. Methods: We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). Results: We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. Conclusions: The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program. UR - https://www.jmir.org/2021/3/e19309 UR - http://dx.doi.org/10.2196/19309 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650980 ID - info:doi/10.2196/19309 ER - TY - JOUR AU - Athanas, Argus AU - McCorrison, Jamison AU - Campistron, Julie AU - Bender, Nick AU - Price, Jamie AU - Smalley, Susan AU - Schork, J. Nicholas PY - 2021/3/2 TI - Characterizing Emotional State Transitions During Prolonged Use of a Mindfulness and Meditation App: Observational Study JO - JMIR Ment Health SP - e19832 VL - 8 IS - 3 KW - mental health KW - mobile apps KW - smartphone KW - mobile phone KW - emotional distress KW - mindfulness N2 - Background: The increasing demand for mental health care, a lack of mental health care providers, and unequal access to mental health care services have created a need for innovative approaches to mental health care. Digital device apps, including digital therapeutics, that provide recommendations and feedback for dealing with stress, depression, and other mental health issues can be used to adjust mood and ultimately show promise to help meet this demand. In addition, the recommendations delivered through such apps can also be tailored to an individual?s needs (ie, personalized) and thereby potentially provide greater benefits than traditional ?one-size-fits-all? recommendations. Objective: This study aims to characterize individual transitions from one emotional state to another during the prolonged use of a digital app designed to provide a user with guided meditations based on their initial, potentially negative, emotional state. Understanding the factors that mediate such transitions can lead to improved recommendations for specific mindfulness and meditation interventions or activities (MMAs) provided in mental health apps. Methods: We analyzed data collected during the use of the Stop, Breathe & Think (SBT) mindfulness app. The SBT app prompts users to input their emotional state before and immediately after engaging with MMAs recommended by the app. Data were collected from more than 650,000 SBT users engaging in nearly 5 million MMAs. We limited the scope of our analysis to users with 10 or more MMA sessions that included at least 6 basal emotional state evaluations. Using clustering techniques, we grouped emotions recorded by individual users and then applied longitudinal mixed effect models to assess the associations between individual recommended MMAs and transitions from one group of emotions to another. Results: We found that basal emotional states have a strong influence on transitions from one emotional state to another after MMA engagement. We also found that different MMAs impact these transitions, and many were effective in eliciting a healthy transition but only under certain conditions. In addition, we observed gender and age effects on these transitions. Conclusions: We found that the initial emotional state of an SBT app user determines the type of SBT MMAs that will have a favorable effect on their transition from one emotional state to another. Our results have implications for the design and use of guided mental health recommendations for digital device apps. UR - https://mental.jmir.org/2021/3/e19832 UR - http://dx.doi.org/10.2196/19832 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650986 ID - info:doi/10.2196/19832 ER - TY - JOUR AU - Hernandez, M. Laura AU - Wetter, W. David AU - Kumar, Santosh AU - Sutton, K. Steven AU - Vinci, Christine PY - 2021/2/24 TI - Smoking Cessation Using Wearable Sensors: Protocol for a Microrandomized Trial JO - JMIR Res Protoc SP - e22877 VL - 10 IS - 2 KW - mHealth KW - microrandomized trial KW - smoking cessation KW - mindfulness KW - tobacco KW - mobile phone N2 - Background: Cigarette smoking has numerous health consequences and is the leading cause of morbidity and mortality in the United States. Mindfulness has the ability to enhance resilience to stressors and can strengthen an individual?s ability to deal with discomfort, which may be particularly useful when managing withdrawal and craving to smoke. Objective: This study aims to evaluate feasibility results from an intervention that provides real-time, real-world mindfulness strategies to a sample of racially and ethnically diverse smokers making a quit attempt. Methods: This study uses a microrandomized trial design to deliver mindfulness-based strategies in real time to individuals attempting to quit smoking. Data will be collected via wearable sensors, a study smartphone, and questionnaires filled out during the in-person study visits. Results: Recruitment is complete, and data management is ongoing. Conclusions: The data collected during this feasibility trial will provide preliminary findings about whether mindfulness strategies delivered in real time are a useful quit smoking aid that warrants additional investigation. Trial Registration: Clinicaltrials.gov NCT03404596; https://clinicaltrials.gov/ct2/show/NCT03404596 International Registered Report Identifier (IRRID): DERR1-10.2196/22877 UR - https://www.researchprotocols.org/2021/2/e22877 UR - http://dx.doi.org/10.2196/22877 UR - http://www.ncbi.nlm.nih.gov/pubmed/33625366 ID - info:doi/10.2196/22877 ER - TY - JOUR AU - Iyer, Laya AU - Iyer, B. Ranjani AU - Kumar, Vetriliaa PY - 2021/1/29 TI - A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study JO - JMIR Form Res SP - e22041 VL - 5 IS - 1 KW - Heartfulness KW - stress management KW - iOS app KW - social-emotional KW - mental health N2 - Background: HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness Institute to deal with daily stress and anxiety in a healthy, productive manner. These tools have proven effective in stress management and mental wellness when administered in a controlled environment by a certified proctor. Objective: This study aimed to explore the app?s effectiveness and evaluate the implementation of the tools. Methods: In this study, 88 participants were recruited and randomly sorted into 2 groups, the HeartBot intervention group (n=46) and the waitlist control group (n=42). Pre- and postsurveys measured participants? stress levels using the Perceived Stress Scale (PSS) and their social-emotional well-being using the EPOCH (Engagement, Perseverance, Optimism, Connectedness, and Happiness) Measure of Adolescent Well-Being before and after they used the app for 21 days for 30 minutes every day. Results: The study received institutional review board approval on August 18, 2019. Participant recruitment lasted from the approval date until September 30, 2019. The 21-day challenge started on October 1, 2019. Of the 135 people who signed up, 88 completed the study. There was a statistically significant difference in the mean PSS scores before and after the intervention (from 18.3 to 7.89; P<.001). The paired Wilcoxon rank sum test on the EPOCH scores indicated a significant difference in the medians of the total scores (W=411.5, P<.001). Conclusions: Evidence from this study shows that HeartBot is an effective app that can be used to manage stress and improve positive characteristics of emotional wellness. Future research and widespread usage of the app under this study are encouraged based on this preliminary evidence of its effectiveness. Trial Registration: ClinicalTrials.gov NCT04589520; https://clinicaltrials.gov/ct2/show/NCT04589520 UR - http://formative.jmir.org/2021/1/e22041/ UR - http://dx.doi.org/10.2196/22041 UR - http://www.ncbi.nlm.nih.gov/pubmed/33455902 ID - info:doi/10.2196/22041 ER - TY - JOUR AU - Sun, Yaoyao AU - Li, Yanyan AU - Wang, Juan AU - Chen, Qingyi AU - Bazzano, N. Alessandra AU - Cao, Fenglin PY - 2021/1/27 TI - Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial JO - J Med Internet Res SP - e23410 VL - 23 IS - 1 KW - mindfulness KW - pregnancy KW - perinatal care KW - depression KW - mHealth KW - mobile health KW - psychosocial intervention N2 - Background: Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. Objective: The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. Methods: Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. Results: A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction ?24=16.2, P=.003) and secondary outcomes (?24=13.1, P=.01 for anxiety; ?24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, ?0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction ?24=18.1, P=.001). Conclusions: Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474 UR - http://www.jmir.org/2021/1/e23410/ UR - http://dx.doi.org/10.2196/23410 UR - http://www.ncbi.nlm.nih.gov/pubmed/33502326 ID - info:doi/10.2196/23410 ER - TY - JOUR AU - Daudén Roquet, Claudia AU - Sas, Corina PY - 2021/1/18 TI - A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design JO - JMIR Res Protoc SP - e20819 VL - 10 IS - 1 KW - brain-computer interface KW - mental well-being KW - depression KW - mindfulness KW - mandala coloring N2 - Background: The regular practice of mindfulness has been shown to provide benefits for mental well-being and prevent depression relapse. Technology-mediated interventions can facilitate the uptake and sustained practice of mindfulness, yet the evaluation of interactive systems, such as brain-computer interfaces, has been little explored. Objective: The objective of this paper is to present an interactive mindfulness-based technology to improve mental well-being in people who have experienced depression. The system, Anima, is a brain-computer interface that augments mandala coloring by providing a generative color palette based on the unfolding mindfulness states during the practice. In addition, this paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants who have experienced depression in the past, have finished treatment within the last year, and can provide informed consent will be able to be recruited. The Anima system, consisting of 2 tablets and a nonintrusive mental activity headband, will be delivered to participants to use during the study. Measures include state and trait mindfulness, depression symptoms, mental well-being, and user experience, and these measures will be taken throughout the baseline, intervention, and monitoring phases. The data collection will take place in the form of a questionnaire before and after each mandala-coloring session and a semistructured interview every 2 weeks. Trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: Study results will offer new insights into the deployment and evaluation of novel interactive brain-computer interfaces for mindfulness training in the context of mental health. Moreover, findings will validate the effectiveness of this training protocol to improve the mental well-being of people who have had depression. Participants will be recruited locally through the National Health Service. Conclusions: Evidence will assist in the design and evaluation of brain-computer interfaces and mindfulness technologies for mental well-being and the necessary services to support people who have experienced depression. International Registered Report Identifier (IRRID): PRR1-10.2196/20819 UR - http://www.researchprotocols.org/2021/1/e20819/ UR - http://dx.doi.org/10.2196/20819 UR - http://www.ncbi.nlm.nih.gov/pubmed/33459604 ID - info:doi/10.2196/20819 ER - TY - JOUR AU - Veling, Wim AU - Lestestuiver, Bart AU - Jongma, Marieke AU - Hoenders, Rogier H. J. AU - van Driel, Catheleine PY - 2021/1/15 TI - Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial JO - J Med Internet Res SP - e17233 VL - 23 IS - 1 KW - virtual reality KW - stress KW - relaxation KW - negative affect KW - positive affect KW - depression KW - anxiety KW - randomized controlled trial N2 - Background: Virtual reality (VR) relaxation is a promising mental health intervention that may be an effective tool for stress reduction but has hardly been tested in clinical trials with psychiatric patients. We developed an easy-to-use VR self-management relaxation tool (VRelax) with immersive 360° nature videos and interactive animated elements. Objective: To investigate the immediate effects of VR relaxation on negative and positive affective states and short-term effects on perceived stress and symptoms in patients with a psychiatric disorder, compared to standard relaxation exercises. Methods: A randomized crossover trial was conducted in 50 patients receiving ambulatory treatment for anxiety, psychotic, depressive, or bipolar disorder. Participants were randomly assigned to start with VRelax or standard relaxation and used both interventions for 10 days at home. They completed 8 visual analog scales of momentary negative and positive affective states before and after each session. Global perceived stress and psychiatric symptoms were measured before and after both intervention periods. Treatment effects were analyzed with multilevel mixed model regression analyses and 2-way analysis of variance. Results: Both VRelax and standard relaxation exercises led to a statistically significant immediate improvement of all negative and positive affective states. Compared to standard relaxation, VRelax resulted in a significantly greater reduction of total negative affective state (change 16.2% versus 21.2%; t1684=?2.02, 95% CI ?18.70 to ?0.28; P=.04). Specifically, VRelax had a stronger beneficial effect on momentary anxiety (t1684=?3.24, 95% CI ?6.86 to ?1.69), sadness (t1684=?2.32, 95% CI ?6.51 to ?0.55), and cheerfulness (t1684=2.35, 95% CI 0.51 to 5.75). There were no significant differences between short-term effects of the two treatments on global perceived stress and symptoms. Conclusions: If the results of this trial are replicated and extended, VRelax may provide a much-needed, effective, easy-to-use self-management relaxation intervention to enhance psychiatric treatments. Trial Registration: Netherlands Trial Register NTR7294; https://www.trialregister.nl/trial/7096 UR - http://www.jmir.org/2021/1/e17233/ UR - http://dx.doi.org/10.2196/17233 UR - http://www.ncbi.nlm.nih.gov/pubmed/33448933 ID - info:doi/10.2196/17233 ER - TY - JOUR AU - Mikolasek, Michael AU - Witt, Margitta Claudia AU - Barth, Jürgen PY - 2021/1/13 TI - Effects and Implementation of a Mindfulness and Relaxation App for Patients With Cancer: Mixed Methods Feasibility Study JO - JMIR Cancer SP - e16785 VL - 7 IS - 1 KW - mobile app KW - mobile phone KW - mindfulness KW - relaxation KW - cancer KW - qualitative research KW - implementation science KW - mHealth KW - evaluation study KW - patient compliance KW - patient participation KW - patient preference N2 - Background: Cancer diagnosis and cancer treatment can cause high levels of distress, which is often not sufficiently addressed in standard medical care. Therefore, a variety of supportive nonpharmacological treatments have been suggested to reduce distress in patients with cancer. However, not all patients use these interventions because of limited access or lack of awareness. To overcome these barriers, mobile health may be a promising way to deliver the respective supportive treatments. Objective: The aim of this study is to evaluate the effects and implementation of a mindfulness and relaxation app intervention for patients with cancer as well as patients? adherence to such an intervention. Methods: In this observational feasibility study with a mixed methods approach, patients with cancer were recruited through the web and through hospitals in Switzerland. All enrolled patients received access to a mindfulness and relaxation app. Patients completed self-reported outcomes (general health, health-related quality of life, anxiety, depression, distress, mindfulness, and fear of progression) at baseline and at weeks 4, 10, and 20. The frequency of app exercise usage was gathered directly through the app to assess the adherence of patients. In addition, we conducted interviews with 5 health professionals for their thoughts on the implementation of the app intervention in standard medical care. We analyzed patients? self-reported outcomes using linear mixed models (LMMs) and qualitative data with content analysis. Results: A total of 100 patients with cancer (74 female) with a mean age of 53.2 years (SD 11.6) participated in the study, of which 25 patients used the app regularly until week 20. LMM analyses revealed improvements in anxiety (P=.04), distress (P<.001), fatigue (P=.01), sleep disturbance (P=.02), quality of life (P=.03), and mindfulness (P<.001) over the course of 20 weeks. Further LMM analyses revealed a larger improvement in distress (P<.001), a moderate improvement in anxiety (P=.001), and a larger improvement in depression (P=.03) in patients with high levels of symptoms at baseline in the respective domains. The interviews revealed that the health professionals perceived the app as a helpful addition to standard care. They also made suggestions for improvements, which could facilitate the implementation of and adherence to such an app. Conclusions: This study indicates that a mindfulness and relaxation app for patients with cancer can be a feasible and effective way to deliver a self-care intervention, especially for highly distressed patients. Future studies should investigate if the appeal of the app can be increased with more content, and the effectiveness of such an intervention needs to be tested in a randomized controlled trial. UR - https://cancer.jmir.org/2021/1/e16785 UR - http://dx.doi.org/10.2196/16785 UR - http://www.ncbi.nlm.nih.gov/pubmed/33439132 ID - info:doi/10.2196/16785 ER - TY - JOUR AU - Ritvo, Paul AU - Ahmad, Farah AU - El Morr, Christo AU - Pirbaglou, Meysam AU - Moineddin, Rahim AU - PY - 2021/1/11 TI - A Mindfulness-Based Intervention for Student Depression, Anxiety, and Stress: Randomized Controlled Trial JO - JMIR Ment Health SP - e23491 VL - 8 IS - 1 KW - online intervention KW - randomized controlled trial KW - university student KW - depression KW - anxiety KW - stress KW - mental health KW - efficacy KW - intervention N2 - Background: University students are experiencing higher levels of distress and mental health disorders than before. In addressing mental health needs, web-based interventions have shown increasing promise in overcoming geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web-based program, guided by mindfulness and cognitive behavioral therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students. Objective: This study?s aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, this study coincided with a university-wide labor strike. Nonetheless, the students? response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to the COVID-19 pandemic as well as future disruptions. Methods: In this parallel-arm RCT, 154 students were randomly allocated to an 8-week MVC intervention (n=76) or a wait-list control (WLC) condition (n=78). The MVC intervention included the following: (1) educational and mindfulness video modules, (2) anonymous peer-to-peer discussions, and (3) anonymous, group-based, professionally guided, 20-minute videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using the following: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR (1) covariance structure were used to evaluate the impact of the intervention, with outcome evaluations performed on both an intention-to-treat (ITT) and per-protocol (PP) basis. Results: Participants (n=154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the two groups. Results under both ITT and PP approaches indicated that there were no statistically significant between-group differences in PHQ-9 (ITT: ?=?0.44, P=.64; PP: ?=?0.62, P=.053), BAI (ITT: ?=?2.06, P=.31; PP: ?=?2.32, P=.27), and FFMQ-SF (ITT: ?=1.33, P=.43; PP: ?=1.44, P=.41) compared to WLC. There was a significant difference for the PSS (ITT: ?=?2.31, P=.03; PP: ?=?2.38, P=.03). Conclusions: During a university labor strike, the MVC program led to statistically significant reductions in PSS compared to the WLC group, but there were no other significant between-group differences. Comparisons with previous cycles of intervention testing, undertaken during nondisrupted university operations, when efficacy was demonstrated, are discussed. Trial Registration: ISRCTN Registry ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275 UR - https://mental.jmir.org/2021/1/e23491 UR - http://dx.doi.org/10.2196/23491 UR - http://www.ncbi.nlm.nih.gov/pubmed/33264098 ID - info:doi/10.2196/23491 ER - TY - JOUR AU - Sturgill, Ronda AU - Martinasek, Mary AU - Schmidt, Trine AU - Goyal, Raj PY - 2021/1/5 TI - A Novel Artificial Intelligence-Powered Emotional Intelligence and Mindfulness App (Ajivar) for the College Student Population During the COVID-19 Pandemic: Quantitative Questionnaire Study JO - JMIR Form Res SP - e25372 VL - 5 IS - 1 KW - mindfulness KW - COVID-19 KW - college students KW - emotional intelligence N2 - Background: Emotional intelligence (EI) and mindfulness can impact the level of anxiety and depression that an individual experiences. These symptoms have been exacerbated among college students during the COVID-19 pandemic. Ajivar is an app that utilizes artificial intelligence (AI) and machine learning to deliver personalized mindfulness and EI training. Objective: The main objective of this research study was to determine the effectiveness of delivering an EI curriculum and mindfulness techniques using an AI conversation platform, Ajivar, to improve symptoms of anxiety and depression during this pandemic. Methods: A total of 99 subjects, aged 18 to 29 years, were recruited from a second-semester group of freshmen students. All participants completed the online TestWell Wellness Inventory at the start and end of the 14-week semester. The comparison group members (49/99, 49%) were given routine mental wellness instruction. The intervention group members (50/99, 51%) were required to complete Ajivar activities in addition to routine mental wellness instruction during the semester, which coincided with the onset of the COVID-19 pandemic. This group also completed assessments to evaluate for anxiety, using the 7-item Generalized Anxiety Disorder (GAD-7) scale, and depression, using the 9-item Patient Health Questionnaire (PHQ-9). Results: Study participants reported a mean age of 19.9 (SD 1.94) years; 27% (27/99) of the group were male and 60% (59/99) identified as Caucasian. No significant demographic differences existed between the comparison and intervention groups. Subjects in the intervention group interacted with Ajivar for a mean time of 1424 (SD 1168) minutes. There was a significant decrease in anxiety, as measured by the GAD-7: the mean score was 11.47 (SD 1.85) at the start of the study compared to 6.27 (SD 1.44) at the end (P<.001). There was a significant reduction in the symptoms of depression measured by the PHQ-9: the mean score was 10.69 (SD 2.04) at the start of the study compared to 6.69 (SD 2.41) at the end (P=.001). Both the intervention and comparison groups independently had significant improvements in the TestWell Wellness Inventory from pretest to posttest. The subgroups in the social awareness and spirituality inventories showed significant improvement in the intervention group. In a subgroup of participants (11/49, 22%) where the GAD-7 was available during the onset of the COVID-19 pandemic, there was an increase in anxiety from the start of the study (mean score 11.63, SD 2.16) to mid-March (ie, onset of the pandemic) (mean score 13.03, SD 1.48; P=.23), followed by a significant decrease at the end of the study period (mean score 5.9, SD 1.44; P=.001). Conclusions: It is possible to deliver EI and mindfulness training in a scalable way using the Ajivar app during the COVID-19 pandemic, resulting in improvements in anxiety, depression, and EI in the college student population. UR - http://formative.jmir.org/2021/1/e25372/ UR - http://dx.doi.org/10.2196/25372 UR - http://www.ncbi.nlm.nih.gov/pubmed/33320822 ID - info:doi/10.2196/25372 ER - TY - JOUR AU - Goldberg, B. Simon AU - Imhoff-Smith, Theodore AU - Bolt, M. Daniel AU - Wilson-Mendenhall, D. Christine AU - Dahl, J. Cortland AU - Davidson, J. Richard AU - Rosenkranz, A. Melissa PY - 2020/11/27 TI - Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial JO - JMIR Ment Health SP - e23825 VL - 7 IS - 11 KW - meditation KW - mindfulness KW - compassion KW - mobile health KW - loneliness KW - randomized controlled trial KW - mobile phone N2 - Background: A growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques. Objective: This study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app?the Healthy Minds Program (HMP)?which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight). Methods: A three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (?18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood. Results: A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=?0.28 to 0.41; Ps?.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified. Conclusions: This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement. Trial Registration: ClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005 UR - http://mental.jmir.org/2020/11/e23825/ UR - http://dx.doi.org/10.2196/23825 UR - http://www.ncbi.nlm.nih.gov/pubmed/33245288 ID - info:doi/10.2196/23825 ER - TY - JOUR AU - Kozlov, Elissa AU - Bantum, Erin AU - Pagano, Ian AU - Walser, Robyn AU - Ramsey, Kelly AU - Taylor, Katherine AU - Jaworski, Beth AU - Owen, Jason PY - 2020/11/27 TI - The Reach, Use, and Impact of a Free mHealth Mindfulness App in the General Population: Mobile Data Analysis JO - JMIR Ment Health SP - e23377 VL - 7 IS - 11 KW - mHealth KW - mindfulness KW - mHealth psychotherapy KW - mHealth mindfulness KW - public health KW - self-management KW - mental health N2 - Background: As smartphones are now used by most Americans, it is increasingly possible for mental health mobile apps to be disseminated to the general public. However, little is known about how mobile mental health apps are used by the general population outside of a controlled research design. Objective: Our objective is to describe how the general population engages with Mindfulness Coach, an iOS- and Android-based app designed to deliver a mindfulness training course. Methods: Using anonymous download and analytics data, we characterized the reach, usage, retention, and impact of Mindfulness Coach. We included mobile analytics data from all unique downloads of Mindfulness Coach between August 1, 2018, and April 8, 2019 (N=104,067) as well as starred reviews from all Mindfulness Coach users who provided reviews of the app as of March 1, 2020. Mindfulness characteristics were measured by an in-app assessment using the Five-Facet Mindfulness Questionnaire?Short Form (FFMQ-SF). Results: Users engaged, on average, in 4.3 visits to the app (SD 8.8; median 2; 90th percentile 8) and associated with an average total of 49.2 interactions with the app (ie, clicks within the app) (SD 113.8; median 19; 90th percentile 105). Users spent an average of 16.2 minutes (SD 63.1) engaged with the app over the full study time period. There were strong linear effects of app engagement on total FFMQ-SF scores. For example, FFMQ-SF scores were associated with more time spent engaged with the app (R2=.23; P<.001). Mindfulness Coach has been reviewed in the Google Play Store 3415 times, with an average rating of 4.7 out of 5 stars, and over 2000 times in the Apple App Store, with an average rating of 4.8 out of 5 stars. Conclusions: These findings suggest that Mindfulness Coach has achieved substantial and sustained reach in the general population; however, it was used less frequently by many downloaders than researchers and designers intended. There was a subpopulation of users who engaged in the app regularly over an extended period of time, and there was a clear relationship between app use and improvements in mindfulness. To strengthen Mindfulness Coach?s public health impact, more research is needed to understand who is using the app and how, and to design strategies to increase user engagement in order for users to receive a larger dose of mindfulness treatment. UR - http://mental.jmir.org/2020/11/e23377/ UR - http://dx.doi.org/10.2196/23377 UR - http://www.ncbi.nlm.nih.gov/pubmed/33245289 ID - info:doi/10.2196/23377 ER - TY - JOUR AU - Matis, Juraj AU - Svetlak, Miroslav AU - Slezackova, Alena AU - Svoboda, Marek AU - ?umec, Rastislav PY - 2020/11/16 TI - Mindfulness-Based Programs for Patients With Cancer via eHealth and Mobile Health: Systematic Review and Synthesis of Quantitative Research JO - J Med Internet Res SP - e20709 VL - 22 IS - 11 KW - eHealth KW - mHealth KW - mindfulness KW - cancer KW - systematic review KW - mobile phone N2 - Background: eHealth mindfulness-based programs (eMBPs) are on the rise in complex oncology and palliative care. However, we are still at the beginning of answering the questions of how effective eMBPs are and for whom, and what kinds of delivery modes are the most efficient. Objective: This systematic review aims to examine the feasibility and efficacy of eMBPs in improving the mental health and well-being of patients with cancer, to describe intervention characteristics and delivery modes of these programs, and to summarize the results of the included studies in terms of moderators, mediators, and predictors of efficacy, adherence, and attrition. Methods: In total, 4 databases (PubMed, PsycINFO, Scopus, and Web of Knowledge) were searched using relevant search terms (eg, mindfulness, program, eHealth, neoplasm) and their variations. No restrictions were imposed on language or publication type. The results of the efficacy of eMBPs were synthesized through the summarizing effect estimates method. Results: A total of 29 published papers describing 24 original studies were included in this review. In general, the results indicate that eMBPs have the potential to reduce the levels of stress, anxiety, depression, fatigue, sleep problems, and pain, and improve the levels of mindfulness, posttraumatic growth, and some parameters of general health. The largest median of Cohen d effect sizes were observed in reducing anxiety and depression (within-subject: median ?0.38, IQR ?0.62 to ?0.27; between-group:median ?0.42, IQR ?0.58 to ?0.22) and facilitating posttraumatic growth (within-subject: median 0.42, IQR 0.35 to 0.48;between-group: median 0.32, IQR 0.22 to 0.39). The efficacy of eMBP may be comparable with that of parallel, face-to-faceMBPs in some cases. All studies that evaluated the feasibility of eMBPs reported that they are feasible for patients with cancer.Potential moderators, mediators, and predictors of the efficacy, attrition, and adherence of eMBPs are discussed. Conclusions: Although the effects of the reviewed studies were highly heterogeneous, the review provides evidence that eMBPs are an appropriate way for mindfulness practice to be delivered to patients with cancer. Thus far, existing eMBPs have mostly attempted to convert proven face-to-face mindfulness programs to the eHealth mode. They have not yet fully exploited the potential of eHealth technology. UR - http://www.jmir.org/2020/11/e20709/ UR - http://dx.doi.org/10.2196/20709 UR - http://www.ncbi.nlm.nih.gov/pubmed/33196452 ID - info:doi/10.2196/20709 ER - TY - JOUR AU - Puzia, Megan AU - Laird, Breanne AU - Green, Jeni AU - Huberty, Jennifer PY - 2020/11/13 TI - Parents? Perceptions of Their Children?s Engagement in a Consumer-Based Meditation Mobile App: Cross-Sectional Survey Study JO - JMIR Pediatr Parent SP - e24536 VL - 3 IS - 2 KW - mindfulness KW - meditation KW - children KW - mental health KW - sleep KW - mHealth N2 - Background: In the United States, nearly half (48%) of school-aged children experience sleep disturbance that results in less than the recommended sleep duration, which may negatively impact mental health and behavior. Mindfulness interventions may improve sleep and mental health in youth. However, there are gaps in the literature regarding how children (2-12 years) and adolescents (13-17 years) practice mindfulness and the extent to which they benefit from these practices. Objective: The purpose of this study was to determine parents? perceptions of their children?s engagement with a consumer-based mindfulness meditation app and the extent to which they believe their children have benefitted from using the app, particularly with regard to sleep. Methods: This study is a secondary analysis of a cross-sectional survey in adult subscribers (N=11,108) to the mindfulness meditation mobile app Calm. Participants who indicated that they had a child or children younger than 18 years (2944/11,108) who used the Calm app were asked additional questions related to their perceptions of their children?s engagement with Calm. Descriptive statistics were used to assess children?s app engagement, and chi-square tests and binary logistic regression models were used to assess differences in children?s usage based on gender and age. Results: Among the survey respondents, approximately half of the parents (1537/2944, 52.21%) reported that their children used Calm. Children used Calm mostly for (1) sleep (1168/1537, 75.99%), (2) stress (491/1537, 31.95%), (3) depression or anxiety (430/1537, 27.98%), and (4) improvement of overall health (215/1537,13.99%). Older children were more likely to begin using Calm to reduce stress, depression, or anxiety, whereas younger children were more likely begin using Calm to improve sleep. Most children used Calm when lying down to go to bed (1113/1529, 72.79%). Children were most likely to use sleep stories at night (1144/1207, 94.78%), followed by music and soundscapes (749/1114, 67.24%), meditations (736/1120, 65.71%), and breathing exercises (610/1092, 55.86%). Nearly all parents believed that using sleep stories was helpful for their children?s sleep (1090/1128, 96.63%), and the majority of parents felt that the other components were also helpful for their children?s sleep (music and soundscapes [570/728, 78.30%], meditations [445/696, 63.94%], and breathing exercises [610/1092, 55.86%]). Conclusions: To our knowledge, this is the first study to explore parents? perceptions of how their children or adolescents use a popular consumer-based mindfulness mobile app (ie, Calm). As the majority of children use the app for sleep, mindfulness meditation mobile apps should consider incorporating age-appropriate sleep content to meet the needs of this audience. More research is needed to confirm the feasibility and effectiveness of mindfulness meditation apps for improving sleep and mental health in children and adolescents. UR - http://pediatrics.jmir.org/2020/2/e24536/ UR - http://dx.doi.org/10.2196/24536 UR - http://www.ncbi.nlm.nih.gov/pubmed/33185564 ID - info:doi/10.2196/24536 ER - TY - JOUR AU - Huberty, Jennifer AU - Puzia, E. Megan AU - Larkey, Linda AU - Irwin, R. Michael AU - Vranceanu, Ana-Maria PY - 2020/11/13 TI - Use of the Consumer-Based Meditation App Calm for Sleep Disturbances: Cross-Sectional Survey Study JO - JMIR Form Res SP - e19508 VL - 4 IS - 11 KW - insomnia KW - mental health KW - mindfulness KW - meditation KW - mobile apps KW - consumer behavior KW - mobile phone N2 - Background: Over 30% of Americans report regular sleep disturbance, and consumers are increasingly seeking strategies to improve sleep. Self-guided mindfulness mobile apps may help individuals improve their sleep. Despite the recent proliferation of sleep content within commercially available mindfulness apps, there is little research on how consumers are using these apps for sleep. Objective: We conducted a cross-sectional survey among subscribers to Calm, a popular, consumer-based, mindfulness-based meditation app, and described and compared how good sleepers, poor sleepers, and those with self-reported insomnia use the app for sleep. Methods: Participants who were paying subscribers of Calm and had used a sleep component of Calm in the last 90 days were invited to complete an investigator-developed survey that included questions about sleep disturbance and the use of Calm for sleep. Based on self-reports of sleep disturbances and of insomnia diagnosis, participants were categorized as ?good sleepers,? ?poor sleepers,? or ?those with insomnia diagnosis.? Chi-square tests compared reasons for downloading the app and usage patterns across participants with and without sleep disturbance. Results: There was a total of 9868 survey respondents. Approximately 10% of participants (1008/9868, 10.21%) were good sleepers, 78% were poor sleepers (7565/9868, 77.66%), and 11% reported a diagnosis of insomnia (1039/9868, 10.53%). The sample was mostly White (8185/9797, 83.55%), non-Hispanic (8929/9423, 94.76%), and female (8166/9578, 85.26%). The most common reasons for sleep disturbances were racing thoughts (7084/8604, 82.33%), followed by stress or anxiety (6307/8604, 73.30%). Poor sleepers and those with insomnia were more likely than good sleepers to have downloaded Calm to improve sleep (?22=1548.8, P<.001), reduce depression or anxiety (?22=15.5, P<.001), or improve overall health (?22=57.6, P<.001). Respondents with insomnia used Calm most often (mean 5.417 days/week, SD 1.936), followed by poor sleepers (mean 5.043 days/week, SD 2.027; F2=21.544, P<.001). The most common time to use Calm was while lying down to sleep (7607/9686, 78.54%), and bedtime use was more common among poor sleepers and those with insomnia (?22=382.7, P<.001). Compared to good and poor sleepers, those with insomnia were more likely to use Calm after waking up at night (?22=410.3, P<.001). Most participants tried to use Calm on a regular basis (5031/8597, 58.52%), but regular nighttime use was most common among those with insomnia (646/977, 66.1%), followed by poor sleepers (4040/6930, 58.30%; ?22=109.3, P<.001). Conclusions: Of the paying subscribers to Calm who have used one of the sleep components, approximately 90% have sleep difficulties, and 77% started using Calm primarily for sleep. These descriptive data point to areas of focus for continued refinement of app features and content, followed by prospective trials testing efficacy of consumer-based meditation mobile apps for improving sleep. UR - http://formative.jmir.org/2020/11/e19508/ UR - http://dx.doi.org/10.2196/19508 UR - http://www.ncbi.nlm.nih.gov/pubmed/33185552 ID - info:doi/10.2196/19508 ER - TY - JOUR AU - Avalos, A. Lyndsay AU - Aghaee, Sara AU - Kurtovich, Elaine AU - Quesenberry Jr, Charles AU - Nkemere, Linda AU - McGinnis, K. MegAnn AU - Kubo, Ai PY - 2020/11/12 TI - A Mobile Health Mindfulness Intervention for Women With Moderate to Moderately Severe Postpartum Depressive Symptoms: Feasibility Study JO - JMIR Ment Health SP - e17405 VL - 7 IS - 11 KW - depression KW - postpartum KW - health services, mental KW - eHealth KW - mental health KW - internet-based intervention KW - mindfulness KW - behavioral intervention KW - mobile phone N2 - Background: Approximately 20% of women suffer from postpartum depression (PPD). Due to barriers such as limited access to care, half of the women with PPD do not receive treatment. Therefore, it is critical to identify effective and scalable interventions. Traditional mindfulness programs have been effective in reducing depressive symptoms, however access remains a barrier. A self-paced mobile health (mHealth) mindfulness program may fit the lifestyle of busy mothers who are unable to attend in-person classes. However, little is known regarding the feasibility or efficacy of mHealth mindfulness interventions in postpartum women with depressive symptoms. Objective: This study aims to assess the feasibility, acceptability, and preliminary efficacy of an mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms. Methods: We conducted a single-arm feasibility trial of an mHealth mindfulness intervention within Kaiser Permanente Northern California (KPNC), a large integrated health care system. Participants were identified through clinician referral and electronic health records via KPNC's universal perinatal depression screening program and recruited by the study team. Inclusion criteria included the following: English-speaking, up to 6 months postpartum with a Patient Health Questionnaire (PHQ-8) score of 10 to 19, and no regular mindfulness/meditation practice. Participants were asked to use a mindfulness app, Headspace, 10 to 20 min/day for 6 weeks. Baseline and postintervention surveys captured data on patient-reported outcomes (depression and stress symptoms, sleep quality, and mindfulness). Semistructured interviews captured acceptability. Retention and adherence were used to assess feasibility. Results: Of the 115 women who were contacted and met the eligibility criteria or declined participation before eligibility assessment, 27 (23%) were enrolled. In addition, 70% (19/27) completed the study. The mean age of participants was 31 years (SD 5.2), 30% (8/27) were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (SD 5.7). Of the women who completed the study, 100% (19/19) used the Headspace app at least once, and nearly half (9/19, 47%) used the app on ?50% of the days during the 6-week intervention period. Of the 16 participants who completed the postintervention interview, 69% (11/16) reported that they were very or extremely satisfied with the app. Interviews indicated that women appreciated the variety of meditations and felt that the program led to reduced anxiety and improved sleep. Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8: ?3.8, P=.004), perceived stress (10-item Perceived Stress Scale: ?6.0, P=.005), and sleep quality (Pittsburgh Sleep Quality Index: ?2.1, P=.02, indicating less sleep disturbance). Improvements in mindfulness were also significant (Five Facet Mindfulness Questionnaire-Short Form: 10.9, P=.01). Conclusions: An mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms is feasible and acceptable. An efficacy trial is warranted. UR - https://mental.jmir.org/2020/11/e17405 UR - http://dx.doi.org/10.2196/17405 UR - http://www.ncbi.nlm.nih.gov/pubmed/33180028 ID - info:doi/10.2196/17405 ER - TY - JOUR AU - Chelidoni, Olga AU - Plans, David AU - Ponzo, Sonia AU - Morelli, Davide AU - Cropley, Mark PY - 2020/10/15 TI - Exploring the Effects of a Brief Biofeedback Breathing Session Delivered Through the BioBase App in Facilitating Employee Stress Recovery: Randomized Experimental Study JO - JMIR Mhealth Uhealth SP - e19412 VL - 8 IS - 10 KW - breathing KW - biofeedback KW - smartphone KW - heart rate variability KW - recovery KW - mindfulness KW - stress KW - mobile phone N2 - Background: Recovery from stress is a predictive factor for cardiovascular health, and heart rate variability (HRV) is suggested to be an index of how well people physiologically recover from stress. Biofeedback and mindfulness interventions that include guided breathing have been shown to be effective in increasing HRV and facilitating stress recovery. Objective: This study aims to assess the effectiveness of a brief app-based breathing intervention (BioBase) in enhancing physiological recovery among employees who were induced to cognitive and emotional stress. Methods: In total, we recruited 75 full-time employees. Interbeat (RR) intervals were recorded continuously for 5 min at baseline and during cognitive and emotional stress induction. The session ended with a 5-min recovery period during which participants were randomly allocated into 3 conditions: app-based breathing (BioBase), mindfulness body scan, or control. Subjective tension was assessed at the end of each period. Results: Subjective tension significantly increased following stress induction. HRV significantly decreased following the stress period. In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups. Conclusions: Biofeedback breathing interventions digitally delivered through a commercially available app can be effective in facilitating stress recovery among employees. These findings contribute to the mobile health literature on the beneficial effects of brief app-based breathing interventions on employees? cardiovascular health. UR - http://mhealth.jmir.org/2020/10/e19412/ UR - http://dx.doi.org/10.2196/19412 UR - http://www.ncbi.nlm.nih.gov/pubmed/33055072 ID - info:doi/10.2196/19412 ER - TY - JOUR AU - Church, Dawson AU - Stapleton, Peta AU - Sabot, Debbie PY - 2020/10/14 TI - App-Based Delivery of Clinical Emotional Freedom Techniques: Cross-Sectional Study of App User Self-Ratings JO - JMIR Mhealth Uhealth SP - e18545 VL - 8 IS - 10 KW - anxiety KW - stress KW - meditation KW - mobile health KW - Emotional Freedom Techniques (EFT) KW - mobile phone N2 - Background: The burgeoning area of mobile health (mHealth) has experienced rapid growth in mobile apps designed to address mental health issues. Although abundant apps offer strategies for managing symptoms of anxiety and stress, information regarding their efficacy is scarce. Objective: This study aimed to assess the effect of an mHealth app on user self-ratings of psychological distress in a sample of 270,461 app users. The Tapping Solution App guides users through the therapeutic protocols of Clinical Emotional Freedom Techniques (EFT), an evidence-based psychophysiological intervention that combines acupressure with elements of cognitive and exposure therapies. Methods: App users provided self-ratings of emotional intensity before and after app sessions (termed ?tapping meditations?) using an 11-point Subjective Units of Distress scale. App user data for 23 tapping meditations, which addressed psychological symptoms of anxiety and stress, were gathered between October 2018 and October 2019, totaling 380,034 completed app sessions. Results: Across 12 anxiety-tapping meditations, the difference in emotional intensity ratings from presession (mean 6.66, SD 0.25) to postsession (mean 3.75, SD 0.30) was statistically significant (P<.001; 95% CI ?2.92 to ?2.91). Across 11 stress-tapping meditations, a statistically significant difference was also found from presession (mean 6.91, SD 0.48) to postsession (mean 3.83, SD 0.54; P<.001; 95% CI ?3.08 to ?3.07). The results are consistent with the literature on the efficacy of Clinical EFT for anxiety and stress when offered in conventional therapeutic formats. Conclusions: The findings provide preliminary support for the effectiveness of the mHealth app in the immediate reduction of self-rated psychological distress. As an adjunct to professional mental health care, the app promises accessible and convenient therapeutic benefits. UR - http://mhealth.jmir.org/2020/10/e18545/ UR - http://dx.doi.org/10.2196/18545 UR - http://www.ncbi.nlm.nih.gov/pubmed/32862128 ID - info:doi/10.2196/18545 ER - TY - JOUR AU - Sieverdes, C. John AU - Treiber, A. Frank AU - Kline, E. Christopher AU - Mueller, Martina AU - Brunner-Jackson, Brenda AU - Sox, Luke AU - Cain, Mercedes AU - Swem, Maria AU - Diaz, Vanessa AU - Chandler, Jessica PY - 2020/10/6 TI - Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial JO - JMIR Form Res SP - e20501 VL - 4 IS - 10 KW - meditation KW - sleep KW - mobile phone KW - prehypertension KW - ethnicity N2 - Background: African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols. Objective: This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs. Methods: A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894). Results: At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03). Conclusions: These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints. UR - https://formative.jmir.org/2020/10/e20501 UR - http://dx.doi.org/10.2196/20501 UR - http://www.ncbi.nlm.nih.gov/pubmed/33021484 ID - info:doi/10.2196/20501 ER - TY - JOUR AU - Cillessen, Linda AU - van de Ven, OM Monique AU - Compen, R. Félix AU - Bisseling, M. Else AU - van der Lee, L. Marije AU - Speckens, EM Anne PY - 2020/10/2 TI - Predictors and Effects of Usage of an Online Mindfulness Intervention for Distressed Cancer Patients: Usability Study JO - J Med Internet Res SP - e17526 VL - 22 IS - 10 KW - internet intervention KW - eHealth KW - mindfulness KW - mindfulness-based cognitive therapy KW - usage KW - log data KW - uptake KW - adherence KW - cancer KW - oncology N2 - Background: One in three cancer patients experience high psychological distress. Mindfulness-based interventions are effective in reducing psychological distress in this patient group. However, these interventions lack availability and flexibility, which may compromise participation in the intervention for cancer patients experiencing late symptoms like fatigue or pain. Therefore, mindfulness-based interventions are increasingly offered via the internet. However, little is known about the usage of these online mindfulness-based interventions. Objective: The aim of this study was to (1) predict uptake of and adherence to online mindfulness-based cognitive therapy (eMBCT) using baseline patient characteristics (demographic, cancer-related, personality, and psychological variables) and (2) examine the relations between adherence and treatment outcomes in eMBCT for cancer patients. Methods: A total of 125 cancer patients were assigned to eMBCT in a parent randomized controlled trial comparing MBCT and eMBCT with treatment as usual in distressed cancer patients. Various usage measures of eMBCT were automatically tracked within the online program. Based on activity of use, participants were classified as nonusers, minimal users, low users, and intended users. Questionnaires were used to assess baseline characteristics (preintervention) and outcomes (pre- and postintervention). To answer the research questions, data were analyzed with t tests, ?2 tests, and linear regression models. Results: Based on weekly activity, participants were classified as nonusers (n=17, 13.6%), who completed no exercises in MBCT; minimal users (n=31, 24.8%), who completed at least one exercise of one to three sessions; low users (n=12, 9.6%), who completed at least one exercise of four to seven sessions; and intended users (n=65, 52.0%), who completed at least one exercise of eight to nine sessions. Nonusers had more fear of cancer recurrence at baseline than users (uptake), and intended users were more conscientious than minimal and low users (adherence). Intended users reported a larger reduction in psychological distress and more improvement of positive mental health (ie, emotional, psychological, and social well-being) after the intervention than other participants. Conclusions: This study showed that adherence was related to improved patient outcomes. Patients with strong fear of recurrence or low levels of conscientiousness should receive extra attention, as they are less likely to respectively start or complete eMBCT. Future research may focus on the development of flexible and adaptive eMBCT programs to fit individual needs. UR - https://www.jmir.org/2020/10/e17526 UR - http://dx.doi.org/10.2196/17526 UR - http://www.ncbi.nlm.nih.gov/pubmed/33006567 ID - info:doi/10.2196/17526 ER - TY - JOUR AU - Meyers, Milena AU - Margraf, Jürgen AU - Velten, Julia PY - 2020/9/29 TI - Psychological Treatment of Low Sexual Desire in Women: Protocol for a Randomized, Waitlist-Controlled Trial of Internet-Based Cognitive Behavioral and Mindfulness-Based Treatments JO - JMIR Res Protoc SP - e20326 VL - 9 IS - 9 KW - sexual desire KW - sexual dysfunction KW - women?s sexual health KW - cognitive behavioral therapy N2 - Background: Psychological therapies are effective treatments for hypoactive sexual desire dysfunction (HSDD; formerly hypoactive sexual desire disorder), a common sexual dysfunction among women. Access to evidence-based treatments, however, remains difficult. Internet-based interventions are effective for a variety of psychological disorders and may be a promising means to close the treatment gap for HSDD. Objective: This article describes the treatment protocol and study design of a randomized controlled trial, aiming to study the efficacy of cognitive behavioral and mindfulness-based interventions delivered via the internet for women with HSDD to a waitlist control group. Outcomes are sexual desire (primary) and sexual distress (secondary). Additional variables (eg, depression, mindfulness, rumination) will be assessed as potential moderators or mediators of treatment success. Methods: A cognitive behavioral and a mindfulness-based self-help intervention for HSDD will be provided online. Overall, 266 women with HSDD will be recruited and assigned either to one of the intervention groups, or to a waitlist control group (2:2:1). Outcome data will be assessed at baseline, at 12 weeks, and at 6 and 12 months after randomization. Intention-to-treat and completer analyses will be conducted. Results: We expect improvements in sexual desire and sexuality-related distress in both intervention groups compared to the waitlist control. Recruitment has begun in January 2019 and is expected to be completed in August 2021. Results will be published in 2022. Conclusions: This study aims to contribute to the improvement and dissemination of psychological treatments for women with HSDD and to clarify whether cognitive behavioral and/or mindfulness-based treatments for HSDD are feasible and effective when delivered via the internet. Trial Registration: ClinicalTrials.gov NCT03780751; https://clinicaltrials.gov/ct2/show/NCT03780751 International Registered Report Identifier (IRRID): DERR1-10.2196/20326 UR - http://www.researchprotocols.org/2020/9/e20326/ UR - http://dx.doi.org/10.2196/20326 UR - http://www.ncbi.nlm.nih.gov/pubmed/32990248 ID - info:doi/10.2196/20326 ER - TY - JOUR AU - Chavez, Johnson Laura AU - Kelleher, Kelly AU - Slesnick, Natasha AU - Holowacz, Eugene AU - Luthy, Ellison AU - Moore, Laura AU - Ford, Jodi PY - 2020/9/24 TI - Virtual Reality Meditation Among Youth Experiencing Homelessness: Pilot Randomized Controlled Trial of Feasibility JO - JMIR Ment Health SP - e18244 VL - 7 IS - 9 KW - virtual reality KW - meditation KW - homelessness KW - stress N2 - Background: Homelessness among youth is devastating, with high rates of substance use disorders and mental health comorbidity. Mindfulness-based interventions that include meditation and mindfulness skills training reduce stress and symptoms of anxiety or depression. However, engaging high-risk youth in interventions is challenging. Virtual reality is a more flexible platform for delivering meditation and may be appealing to youth. Objective: The study objectives were to evaluate the feasibility of delivering virtual reality meditation and of collecting outcome measures, including anxiety and physiologic stress. Methods: A sample of 30 youth experiencing homelessness was enrolled in the study. Youth were randomized to receive 10 minutes of one of three interventions: (1) virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text. Subjects who consented to the study attended two research visits. The first visit collected survey measures of demographics, mental health, and substance use, and oriented subjects to the intervention platforms. The second visit (1-3 days later) delivered the intervention and collected pre and post outcome measures of anxiety and physiologic stress (salivary cortisol). Changes in anxiety and cortisol at the second visit were compared across groups using a linear regression model in which the primary analysis compared virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery. Results: Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively). After controlling for baseline values, there were no significant group differences in changes in anxiety scores or cortisol levels. In comparing virtual reality meditation and audio meditation, the effect size for anxiety was moderate (Cohen d=0.58) while the effect size for cortisol was small (Cohen d=0.08). Conclusions: Preliminary results suggest that virtual reality meditation has a moderate benefit for anxiety but not physiologic stress. Future research is needed to confirm these results in a larger sample and to investigate whether the effects are sustained or increase with repeated use of virtual reality mediation. Virtual reality meditation appears feasible to deliver among homeless youth and merits further study. Trial Registration: ClinicalTrials.gov NCT04004520; https://clinicaltrials.gov/ct2/show/NCT04004520 UR - http://mental.jmir.org/2020/9/e18244/ UR - http://dx.doi.org/10.2196/18244 UR - http://www.ncbi.nlm.nih.gov/pubmed/32969834 ID - info:doi/10.2196/18244 ER - TY - JOUR AU - Norman, P. Kim AU - Govindjee, Anita AU - Norman, R. Seth AU - Godoy, Michael AU - Cerrone, L. Kimberlie AU - Kieschnick, W. Dustin AU - Kassler, William PY - 2020/9/23 TI - Natural Language Processing Tools for Assessing Progress and Outcome of Two Veteran Populations: Cohort Study From a Novel Online Intervention for Posttraumatic Growth JO - JMIR Form Res SP - e17424 VL - 4 IS - 9 KW - natural language analysis KW - emotional tone KW - personality KW - values KW - PTSD KW - military sexual trauma KW - online interventions KW - internet-based cognitive behavioral therapy KW - narrative therapy KW - mindfulness N2 - Background: Over 100 million Americans lack affordable access to behavioral health care. Among these, military veterans are an especially vulnerable population. Military veterans require unique behavioral health services that can address military experiences and challenges transitioning to the civilian sector. Real-world programs to help veterans successfully transition to civilian life must build a sense of community, have the ability to scale, and be able to reach the many veterans who cannot or will not access care. Digitally based behavioral health initiatives have emerged within the past few years to improve this access to care. Our novel behavioral health intervention teaches mindfulness-based cognitive behavioral therapy and narrative therapy using peer support groups as guides, with human-facilitated asynchronous online discussions. Our study applies natural language processing (NLP) analytics to assess effectiveness of our online intervention in order to test whether NLP may provide insights and detect nuances of personal change and growth that are not currently captured by subjective symptom measures. Objective: This paper aims to study the value of NLP analytics in assessing progress and outcomes among combat veterans and military sexual assault survivors participating in novel online interventions for posttraumatic growth. Methods: IBM Watson and Linguistic Inquiry and Word Count tools were applied to the narrative writings of combat veterans and survivors of military sexual trauma who participated in novel online peer-supported group therapies for posttraumatic growth. Participants watched videos, practiced skills such as mindfulness meditation, told their stories through narrative writing, and participated in asynchronous, facilitated online discussions with peers. The writings, including online postings, by the 16 participants who completed the program were analyzed after completion of the program. Results: Our results suggest that NLP can provide valuable insights on shifts in personality traits, personal values, needs, and emotional tone in an evaluation of our novel online behavioral health interventions. Emotional tone analysis demonstrated significant decreases in fear and anxiety, sadness, and disgust, as well as increases in joy. Significant effects were found for personal values and needs, such as needing or desiring closeness and helping others, and for personality traits of openness, conscientiousness, extroversion, agreeableness, and neuroticism (ie, emotional range). Participants also demonstrated increases in authenticity and clout (confidence) of expression. NLP results were generally supported by qualitative observations and analysis, structured data, and course feedback. Conclusions: The aggregate of results in our study suggest that our behavioral health intervention was effective and that NLP can provide valuable insights on shifts in personality traits, personal values, and needs, as well as measure changes in emotional tone. NLP?s sensitivity to changes in emotional tone, values, and personality strengths suggests the efficacy of NLP as a leading indicator of treatment progress. UR - https://formative.jmir.org/2020/9/e17424 UR - http://dx.doi.org/10.2196/17424 UR - http://www.ncbi.nlm.nih.gov/pubmed/32769074 ID - info:doi/10.2196/17424 ER - TY - JOUR AU - Schuurmans, T. Angela A. AU - Nijhof, S. Karin AU - Scholte, Ron AU - Popma, Arne AU - Otten, Roy PY - 2020/9/23 TI - Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e19881 VL - 9 IS - 9 KW - Adolescents KW - Autonomic nervous system KW - Cortisol KW - Meditation KW - Neurofeedback KW - Posttraumatic stress KW - Randomized controlled trial KW - Trauma N2 - Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents? intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration: Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689 International Registered Report Identifier (IRRID): DERR1-10.2196/19881 UR - http://www.researchprotocols.org/2020/9/e19881/ UR - http://dx.doi.org/10.2196/19881 UR - http://www.ncbi.nlm.nih.gov/pubmed/32965226 ID - info:doi/10.2196/19881 ER - TY - JOUR AU - Campos, Daniel AU - Navarro-Gil, Mayte AU - Herrera-Mercadal, Paola AU - Martínez-García, Laura AU - Cebolla, Ausiàs AU - Borao, Luis AU - López-Del-Hoyo, Yolanda AU - Castilla, Diana AU - del Río, Eva AU - García-Campayo, Javier AU - Quero, Soledad PY - 2020/8/14 TI - Feasibility of the Internet Attachment?Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial JO - JMIR Res Protoc SP - e16717 VL - 9 IS - 8 KW - compassion KW - self-criticism KW - feasibility studies KW - internet KW - happiness KW - meditation N2 - Background: Compassion-based interventions delivered over the internet are showing promising results for the promotion of psychological health and well-being. Several studies have highlighted their feasibility, acceptance, and preliminary efficacy. However, this is an incipient field of research, and to the best of our knowledge, there are no data available from Spanish-speaking countries. Objective: The aim of this study is to investigate the feasibility, acceptance, and preliminary efficacy of the Internet Attachment?Based Compassion Therapy (iABCT), a web-based version of the Attachment-Based Compassion Therapy, in Spanish speakers from the general population. Methods: This feasibility study features a single-arm, uncontrolled, within-group design with an embedded qualitative and quantitative process evaluation at baseline, immediately after the intervention and at the 3-month follow-up. A minimum of 35 participants from the general population will be allocated to iABCT. Feasibility measures will include attrition rate, patterns of use of the web-based system, and participants? acceptability, usability, and opinion. The primary outcome was measured using the Pemberton Happiness Index. Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire). Mixed models will be used to evaluate primary and secondary outcome measures. A qualitative content analysis of the participants? qualitative responses will also be performed. Results: Enrollment started in February 2020 and will be finished in April 2020. Data analysis will start in October 2020. Conclusions: To our knowledge, this study will, for the first time, show data on the feasibility, acceptability, and preliminary efficacy of web-based compassion (and self-compassion) training?that is, the adapted iABCT?in Spanish speakers from the general population. Further aspects of their implementation (ie, facilitators, barriers, and unwanted effects) and mechanisms of change will be investigated. This study will allow the revision and fine-tuning of the developed intervention, study design, and planning procedures, as well as the initiation of a future randomized controlled trial. Trial Registration: Clinicaltrials.gov: NCT03918746. Registered on April 17, 2019. Protocol version 1, 6 March 2019. International Registered Report Identifier (IRRID): PRR1-10.2196/16717 UR - http://www.researchprotocols.org/2020/8/e16717/ UR - http://dx.doi.org/10.2196/16717 UR - http://www.ncbi.nlm.nih.gov/pubmed/32384051 ID - info:doi/10.2196/16717 ER - TY - JOUR AU - Goetz, Maren AU - Schiele, Claudia AU - Müller, Mitho AU - Matthies, M. Lina AU - Deutsch, M. Thomas AU - Spano, Claudio AU - Graf, Johanna AU - Zipfel, Stephan AU - Bauer, Armin AU - Brucker, Y. Sara AU - Wallwiener, Markus AU - Wallwiener, Stephanie PY - 2020/8/11 TI - Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study JO - J Med Internet Res SP - e17593 VL - 22 IS - 8 KW - pregnancy KW - high-risk pregnancy KW - hospitalization KW - preterm labor KW - anxiety KW - depression KW - psychological stress KW - mindfulness KW - stress reduction KW - mobile app N2 - Background: Peripartum depression and anxiety disorders are highly prevalent and are correlated with adverse maternal and neonatal outcomes. Antenatal care in Germany does not yet include structured screening and effective low-threshold treatment options for women facing peripartum depression and anxiety disorders. Mindfulness-based interventions (MBIs) are increasingly becoming a focus of interest for the management of such patients. Studies have shown a decrease in pregnancy-related stress and anxiety in expectant mothers following mindfulness programs. Objective: The aim of this study was to explore the clinical effectiveness of a 1-week electronic course of mindfulness on prenatal depression and anxiety in hospitalized, high-risk pregnant women. We hypothesized that participating in a 1-week electronic MBI (eMBI) could alleviate symptoms of depression and anxiety during the hospital stay. Methods: A prospective pilot study with an explorative study design was conducted from January to May 2019 in a sample of 68 women hospitalized due to high-risk pregnancies. After enrolling into the study, the participants were given access to an eMBI app on how to deal with stress, anxiety, and symptoms of depression. Psychometric parameters were assessed via electronic questionnaires comprising the Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI-S), and abridged version of the Pregnancy-Related Anxiety Questionnaire (PRAQ-R). Results: We observed a high prevalence of peripartum depression and anxiety among hospitalized high-risk pregnant women: 39% (26/67) of the study participants in the first assessment and 41% (16/39) of the participants in the second assessment achieved EPDS scores above the cutoff value for minor/major depression. The number of participants with anxiety levels above the cutoff value (66% [45/68] of the participants in the first assessment and 67% [26/39] of the participants in the second assessment) was significantly more than that of the participants with anxiety levels below the cutoff value, as measured with the STAI-S. After completing the 1-week electronic course on mindfulness, the participants showed a significant reduction in the mean state anxiety levels (P<.03). Regarding pregnancy-related anxiety, participants who completed more than 50% of the 1-week course showed lower scores in PRAQ-R in the second assessment (P<.05). No significant changes in the EPDS scores were found after completing the intervention. Conclusions: Peripartum anxiety and depression represent a relevant health issue in hospitalized pregnant patients. Short-term eMBIs could have the potential to reduce anxiety levels and pregnancy-related anxiety. However, we observed that compliance to eMBI seems to be related to lower symptoms of pregnancy-related stress among high-risk patients. eMBIs represent accessible mental health resources at reduced costs and can be adapted for hospitalized patients during pregnancy. UR - https://www.jmir.org/2020/8/e17593 UR - http://dx.doi.org/10.2196/17593 UR - http://www.ncbi.nlm.nih.gov/pubmed/32780023 ID - info:doi/10.2196/17593 ER - TY - JOUR AU - Goldenhersch, Emilio AU - Thrul, Johannes AU - Ungaretti, Joaquín AU - Rosencovich, Nicolas AU - Waitman, Cristian AU - Ceberio, Rodriguez Marcelo PY - 2020/7/29 TI - Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence JO - J Med Internet Res SP - e17571 VL - 22 IS - 7 KW - smoking cessation KW - nicotine dependence KW - craving KW - virtual reality KW - mindfulness KW - digital therapy KW - mHealth KW - mobile phone N2 - Background: Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation. Objective: This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness. Methods: A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit. Results: Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (?21=8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program. Conclusions: Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes. Trial Registration: ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181 UR - http://www.jmir.org/2020/7/e17571/ UR - http://dx.doi.org/10.2196/17571 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723722 ID - info:doi/10.2196/17571 ER - TY - JOUR AU - Weerdmeester, Joanneke AU - van Rooij, MJW Marieke AU - Engels, CME Rutger AU - Granic, Isabela PY - 2020/7/23 TI - An Integrative Model for the Effectiveness of Biofeedback Interventions for Anxiety Regulation: Viewpoint JO - J Med Internet Res SP - e14958 VL - 22 IS - 7 KW - biofeedback KW - neurofeedback KW - anxiety KW - appraisal KW - mechanisms KW - mental health KW - eHealth KW - video games KW - wearable technology KW - review KW - mobile phone UR - https://www.jmir.org/2020/7/e14958 UR - http://dx.doi.org/10.2196/14958 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706654 ID - info:doi/10.2196/14958 ER - TY - JOUR AU - Huberty, Jennifer AU - Eckert, Ryan AU - Puzia, Megan AU - Laird, Breanne AU - Larkey, Linda AU - Mesa, Ruben PY - 2020/7/21 TI - A Novel Educational Control Group Mobile App for Meditation Interventions: Single-Group Feasibility Trial JO - JMIR Form Res SP - e19364 VL - 4 IS - 7 KW - feasibility KW - smartphone KW - mHealth KW - digital health KW - cancer KW - beta test N2 - Background: Smartphone ownership is becoming ubiquitous among US adults, making the delivery of health interventions via a mobile app (ie, mobile health [mHealth]) attractive to many researchers and clinicians. Meditation interventions have become popular and have been delivered to study participants via mobile apps to improve a range of health outcomes in both healthy adults and those with chronic diseases. However, these meditation mHealth interventions have been limited by a lack of high-quality control groups. More specifically, these studies have lacked consistency in their use of active, time-matched, and attention-matched control groups. Objective: The purpose of this study is to beta test a novel health education podcast control condition delivered via a smartphone app that would be a strong comparator to be used in future studies of app-based meditation interventions. Methods: Patients with myeloproliferative neoplasm (MPN) cancer were recruited nationally. Upon enrollment, participants were informed to download the investigator-developed health education podcast app onto their mobile phone and listen to ~60 min/week of cancer-related educational podcasts for 12 weeks. The benchmarks for feasibility included ?70% of participants completing ?70% of the prescribed 60 min/week of podcasts, ?70% of participants reporting that they were satisfied with the intervention, and ?70% of participants reporting that they enjoyed the health education podcasts. Results: A total of 96 patients with MPN were enrolled in the study; however, 19 never began the intervention. Of the 77 patients who participated in the intervention, 39 completed the entire study (ie, sustained participation through the follow-up period). Participation averaged 103.2 (SD 29.5) min/week. For 83.3% (10/12) of the weeks, at least 70% of participants completed at least 70% of their total prescribed use. Almost half of participants reported that they enjoyed the health education podcasts (19/39, 48.7%) and were satisfied with the intervention (17/39, 43.6%). There were no significant changes in cancer-related outcomes from baseline to postintervention. Conclusions: A 12-week, health education podcast mobile app was demanded but not accepted in a sample of patients with cancer. Using the mobile app was not associated with significant changes in cancer-related symptoms. Based on findings from this study, a health education podcast mobile app may be a feasible option as a time- and attention-matched control group for efficacy trials with more extensive formative research for the content of the podcasts and its acceptability by the specific population. Trial Registration: ClinicalTrials.gov NCT03907774; https://clinicaltrials.gov/ct2/show/NCT03907774 UR - http://formative.jmir.org/2020/7/e19364/ UR - http://dx.doi.org/10.2196/19364 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706719 ID - info:doi/10.2196/19364 ER - TY - JOUR AU - El Morr, Christo AU - Ritvo, Paul AU - Ahmad, Farah AU - Moineddin, Rahim AU - PY - 2020/7/17 TI - Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial JO - JMIR Ment Health SP - e18595 VL - 7 IS - 7 KW - virtual community KW - virtual care KW - mindfulness KW - depression KW - anxiety KW - stress KW - students KW - online KW - randomized controlled trial KW - Canada N2 - Background: A student mental health crisis is increasingly acknowledged and will only intensify with the COVID-19 crisis. Given accessibility of methods with demonstrated efficacy in reducing depression and anxiety (eg, mindfulness meditation and cognitive behavioral therapy [CBT]) and limitations imposed by geographic obstructions and localized expertise, web-based alternatives have become vehicles for scaled-up delivery of benefits at modest cost. Mindfulness Virtual Community (MVC), a web-based program informed by CBT constructs and featuring online videos, discussion forums, and videoconferencing, was developed to target depression, anxiety, and experiences of excess stress among university students. Objective: The aim of this study was to assess the effectiveness of an 8-week web-based mindfulness and CBT program in reducing symptoms of depression, anxiety, and stress (primary outcomes) and increasing mindfulness (secondary outcome) within a randomized controlled trial (RCT) with undergraduate students at a large Canadian university. Methods: An RCT was designed to assess undergraduate students (n=160) who were randomly allocated to a web-based guided mindfulness?CBT condition (n=80) or to a waitlist control (WLC) condition (n=80). The 8-week intervention consisted of a web-based platform comprising (1) 12 video-based modules with psychoeducation on students? preidentified life challenges and applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided 20-minute live videoconferences. The outcomes (depression, anxiety, stress, and mindfulness) were measured via an online survey at baseline and at 8 weeks postintervention using the Patient Health Questionnaire-9 (PHQ9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible covariates (gender, age, country of birth, ethnicity, English as first language, paid work, unpaid work, relationship status, physical exercise, self-rated health, and access to private mental health counseling). Results: Of the 159 students who provided T1 data, 32 were males and 125 were females with a mean age of 22.55 years. Participants in the MVC (n=79) and WLC (n=80) groups were similar in sociodemographic characteristics at T1 with the exception of gender and weekly hours of unpaid volunteer work. At postintervention follow-up, according to the adjusted comparisons, there were statistically significant between-group reductions in depression scores (?=?2.21, P=.01) and anxiety scores (?=?4.82, P=.006), and a significant increase in mindfulness scores (?=4.84, P=.02) compared with the WLC group. There were no statistically significant differences in perceived stress for MVC (?=.64, P=.48) compared with WLC. Conclusions: With the MVC intervention, there were significantly reduced depression and anxiety symptoms but no significant effect on perceived stress. Online mindfulness interventions can be effective in addressing common mental health conditions among postsecondary populations on a large scale, simultaneously reducing the current burden on traditional counseling services. Trial Registration: ISRCTN Registry ISRCTN12249616; http://www.isrctn.com/ISRCTN12249616 UR - http://mental.jmir.org/2020/7/e18595/ UR - http://dx.doi.org/10.2196/18595 UR - http://www.ncbi.nlm.nih.gov/pubmed/32554380 ID - info:doi/10.2196/18595 ER - TY - JOUR AU - Do, Van Vuong AU - Spears, Adams Claire AU - Van Minh, Hoang AU - Huang, Jidong AU - Redmon, Buffington Pamela AU - Xuan Long, Nguyen AU - Eriksen, Paul Michael PY - 2020/6/24 TI - Perceptions About Mindfulness and Text Messaging for Smoking Cessation in Vietnam: Results From a Qualitative Study JO - JMIR Mhealth Uhealth SP - e17337 VL - 8 IS - 6 KW - mHealth KW - mobile health KW - text messages KW - smoking KW - smoking cessation KW - mobile phone N2 - Background: With 15.6 million smokers, Vietnam is one of the top 10 largest cigarette-consuming countries in the world. Unfortunately, smoking cessation programs are still scarce in Vietnam. Mindfulness-based and text messaging?based interventions have been increasingly used in smoking cessation studies in developed countries, with promising results. Given the exponential growth of mobile phone usage in Vietnam in recent years, mobile health interventions could be a potential strategy to increase smoking cessation in Vietnam. However, substantial cultural adaptations are needed to optimize the effectiveness of these interventions among Vietnamese smokers. Objective: This study aims to involve qualitative research to inform the development of a mindfulness-based text messaging smoking cessation intervention for Vietnamese smokers. Methods: A total of 10 focus groups were conducted with 71 Vietnamese male smokers aged between 18 and 65 years (5-9 participants per focus group). Overall, 5 focus groups were conducted with smokers who had the intention to quit (ie, preparation stage of change in the transtheoretical model), and 5 focus groups were conducted with smokers who did not have the intention to quit (contemplation or precontemplation stage). The focus groups were audio recorded, transcribed verbatim, and analyzed using NVivo 12 software (QSR International). Results: The major themes included smoking triggers, barriers and facilitators for quitting, the perceptions of text messaging and mindfulness approaches for smoking cessation, and suggestions for the development of a text messaging?based smoking cessation program. Common smoking triggers included stress, difficulties concentrating, and fatigue. Frequently encountering other people who were smoking was a common barrier to quitting. However, participants indicated that concerns about the harmful effects of smoking on themselves and their wives and children, and encouragement from family members could motivate them to quit. The participants preferred diverse message content, including information about the consequences of smoking, encouragement to quit, and tips to cope with cravings. They suggested that text messages be clear and concise and use familiar language. Most smokers perceived that mindfulness training could be useful for smoking cessation. However, some suggested that videos or in-person training may also be needed to supplement teaching mindfulness through text messages. Conclusions: This study provides important insights to inform the development of a text messaging?based smoking cessation program that incorporates mindfulness for Vietnamese male smokers. The results could also be useful for informing similar programs in other low- and middle-income countries. UR - http://mhealth.jmir.org/2020/6/e17337/ UR - http://dx.doi.org/10.2196/17337 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442140 ID - info:doi/10.2196/17337 ER - TY - JOUR AU - Pizzoli, Francesca Silvia Maria AU - Marzorati, Chiara AU - Mazzoni, Davide AU - Pravettoni, Gabriella PY - 2020/6/17 TI - An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e19236 VL - 9 IS - 6 KW - relaxation KW - guided meditation KW - internet-based intervention KW - social isolation KW - stress KW - COVID-19 KW - mental health KW - public health N2 - Background: Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations. Objective: The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic. Methods: The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences. Results: Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants? perceived psychological state. Conclusions: The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic. International Registered Report Identifier (IRRID): PRR1-10.2196/19236 UR - http://www.researchprotocols.org/2020/6/e19236/ UR - http://dx.doi.org/10.2196/19236 UR - http://www.ncbi.nlm.nih.gov/pubmed/32530814 ID - info:doi/10.2196/19236 ER - TY - JOUR AU - Greenberg, Jonathan AU - Popok, J. Paula AU - Lin, Ann AU - Kulich, J. Ronald AU - James, Peter AU - Macklin, A. Eric AU - Millstein, A. Rachel AU - Edwards, R. Robert AU - Vranceanu, Ana-Maria PY - 2020/6/8 TI - A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial JO - JMIR Form Res SP - e18703 VL - 4 IS - 6 KW - chronic pain KW - meditation KW - walking KW - feasibility studies KW - actigraphy N2 - Background: Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. Objective: This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. Methods: Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. Results: Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. Conclusions: These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. Trial Registration: ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916 UR - https://formative.jmir.org/2020/6/e18703 UR - http://dx.doi.org/10.2196/18703 UR - http://www.ncbi.nlm.nih.gov/pubmed/32348281 ID - info:doi/10.2196/18703 ER - TY - JOUR AU - Rung, Lisann Ariane AU - Oral, Evrim AU - Berghammer, Lara AU - Peters, S. Edward PY - 2020/6/2 TI - Feasibility and Acceptability of a Mobile Mindfulness Meditation Intervention Among Women: Intervention Study JO - JMIR Mhealth Uhealth SP - e15943 VL - 8 IS - 6 KW - mindfulness KW - mobile phone KW - depressive symptoms KW - women KW - Louisiana N2 - Background: Traditional mindfulness-based stress reduction programs are resource intensive for providers and time- and cost-intensive for participants, but the use of mobile technologies may be particularly convenient and cost-effective for populations that are busy, less affluent, or geographically distant from skilled providers. Women in southern Louisiana live in a vulnerable, disaster-prone region and are highly stressed, making a mobile program particularly suited to this population. Objective: This study aimed to (1) assess the feasibility and acceptability of a mobile mindfulness app in real-world conditions in a pilot study of a community sample of women residing in southern Louisiana, (2) describe predictors of app usage, and (3) assess the effect of the app on secondary health outcomes. Methods: Women were recruited from an oil spill study on health. A total of 236 women completed a baseline survey, were offered the mobile mindfulness program, and completed a follow-up survey. Subjects were asked to download and use the app for at least 30 days for 10 min. All study procedures were completed on the web. Primary outcomes were feasibility and acceptability of the app and characteristics of app utilization. Secondary outcomes included mindfulness, depression, perceived stress, sleep quality, physical activity, BMI, and healthy eating. Results: Overall, 74.2% (236/318) of subjects completed the follow-up survey, and 13.5% (43/318) used the app. The main barrier to app usage was lack of time, cited by 37% (16/43) of users and 48.7% (94/193) of nonusers of the app. Women who chose to use the app were more highly educated (16/43, 63% had a college education vs 65/193, 33.7% of nonparticipants; P<.001), had higher incomes (23/43, 58% had incomes >US $50,000 per year vs 77/193, 43.0% of nonparticipants), and were employed (34/43, 79% vs 122/193, 63.2% of nonparticipants; P=.047). Those who engaged with the app did so at high levels, with 72% (31/43) of participants self-reporting the completion of some or all sessions and 74% (32/43) reporting high levels of satisfaction with the app. Participation with the app had a beneficial impact on depression (odds ratio [OR] 0.3, 95% CI 0.11-0.81), sleep quality (OR 0.1, 95% CI 0.02-0.96), sleep duration (OR 0.3, 95% CI 0.07-0.86), sleep latency (OR 0.3, 95% CI 0.11-0.81), and physical activity (2.8 95% CI 1.0-7.8), but mindfulness scores did not change from baseline to follow-up. Conclusions: The Headspace mobile mindfulness app was easy and cost-effective to implement and acceptable to those who participated, but few women elected to try it. The unique characteristics of this southern Louisiana population suggest that more intense promotion of the benefits of mindfulness training is needed, perhaps in conjunction with some therapist or researcher support. Several short-term benefits of the app were identified, particularly for depression and sleep. UR - https://mhealth.jmir.org/2020/6/e15943 UR - http://dx.doi.org/10.2196/15943 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442147 ID - info:doi/10.2196/15943 ER - TY - JOUR AU - Subnis, B. Utkarsh AU - Farb, AS Norman AU - Piedalue, Laura Katherine-Ann AU - Speca, Michael AU - Lupichuk, Sasha AU - Tang, A. Patricia AU - Faris, Peter AU - Thoburn, Mark AU - Saab, J. Bechara AU - Carlson, E. Linda PY - 2020/5/11 TI - A Smartphone App?Based Mindfulness Intervention for Cancer Survivors: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15178 VL - 9 IS - 5 KW - mobile health KW - psycho-oncology KW - mindfulness KW - mind-body therapies N2 - Background: Cancer patients transitioning to survivorship after completing cancer treatments need psychosocial interventions to manage stressors such as anxiety, depression, and fear of cancer recurrence. Mindfulness-based interventions (MBIs) are effective for treating these symptoms; however, cancer survivors are often unable to participate in face-to-face interventions because of difficulties such as work and family commitments, treatment-related side-effects, scheduling conflicts, and geography. Smartphone app?based MBIs are an innovative way to deliver psychosocial cancer care and can overcome several such difficulties, since patients can participate at their own convenience. Objective: The SEAMLESS (Smartphone App?Based Mindfulness Intervention for Cancer Survivors) study aims to evaluate the efficacy of a tailored app-based mindfulness intervention for cancer survivors (the Am Mindfulness-Based Cancer Survivorship?MBCS?Journey) for treating (1) symptoms of stress (primary outcome), as well as (2) fear of cancer recurrence, anxiety, depression, fatigue, and overall physical functioning (secondary outcomes). This is the first Canadian efficacy trial of a tailored mindfulness app intervention in cancer survivors. Methods: This is a randomized waitlist-controlled trial, which will evaluate the effectiveness of Am MBCS for impacting the primary and secondary outcomes in cancer survivors who have completed all their cancer treatments. Outcomes will be assessed using web-based surveys with validated psychometric instruments at (1) baseline, (2) mid-intervention (2 weeks later), (3) immediately postintervention (4 weeks), (4) 3 months postbaseline, (5) 6 months postbaseline, and (6) 12 months postbaseline. The waitlist group will complete all assessments and will cross over to the intervention condition after the 3-month assessment. In addition, data will be obtained by the smartphone app itself, which includes users? engagement with the app-based intervention, their emotional state (eg, angry and elated) from a user-inputted digital emotion-mapping board, and psychobiometric data using photoplethysmography technology. Results: The study received ethics approval in September 2018 and recruitment commenced in January 2019. Participants are being recruited through a provincial cancer registry, and the majority of participants currently enrolled are breast (44/83, 53%) or colorectal (17/83, 20%) cancer survivors, although some survivors of other cancer are also present. Data collection for analysis of the primary outcome time-point will be complete by September 2019, and the follow-up data will be collected and analyzed by September 2020. Data will be analyzed to determine group differences using linear mixed modelling statistical techniques. Conclusions: Cancer care providers are uncertain about the efficacy of app-based mindfulness interventions for patients, which are available in great supply in today?s digital world. This study will provide rigorously evaluated efficacy data for an app-based mindfulness intervention for cancer survivors, which if helpful, could be made available for psychosocial care at cancer centers worldwide. Trial Registration: ClinicalTrials.gov NCT03484000; https://clinicaltrials.gov/ct2/show/NCT03484000 International Registered Report Identifier (IRRID): DERR1-10.2196/15178 UR - https://www.researchprotocols.org/2020/5/e15178 UR - http://dx.doi.org/10.2196/15178 UR - http://www.ncbi.nlm.nih.gov/pubmed/32390591 ID - info:doi/10.2196/15178 ER - TY - JOUR AU - Sado, Mitsuhiro AU - Kosugi, Teppei AU - Ninomiya, Akira AU - Nagaoka, Maki AU - Park, Sunre AU - Fujisawa, Daisuke AU - Shirahase, Joichiro AU - Mimura, Masaru PY - 2020/5/8 TI - Mindfulness-Based Cognitive Therapy for Improving Subjective Well-Being Among Healthy Individuals: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15892 VL - 9 IS - 5 KW - mindfulness-based cognitive therapy KW - subjective well-being KW - healthy individuals KW - randomized controlled trial KW - cost-effectiveness N2 - Background: Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being. Objective: This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals. Methods: This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio. Results: This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020. Conclusions: This study is unique in that it investigates MBCT?s effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376 International Registered Report Identifier (IRRID): DERR1-10.2196/15892 UR - https://www.researchprotocols.org/2020/5/e15892 UR - http://dx.doi.org/10.2196/15892 UR - http://www.ncbi.nlm.nih.gov/pubmed/32005642 ID - info:doi/10.2196/15892 ER - TY - JOUR AU - Roy, Alexandra AU - Druker, Susan AU - Hoge, A. Elizabeth AU - Brewer, A. Judson PY - 2020/4/1 TI - Physician Anxiety and Burnout: Symptom Correlates and a Prospective Pilot Study of App-Delivered Mindfulness Training JO - JMIR Mhealth Uhealth SP - e15608 VL - 8 IS - 4 KW - anxiety KW - burnout KW - mindfulness KW - app KW - mHealth KW - physician KW - smartphone KW - digital therapeutics N2 - Background: Physician burnout is on the rise, yet little is known about its relationship to anxiety. Mindfulness-based stress reduction has demonstrated decreases in anxiety, yet physicians have reported reluctance to engage in it due to significant time commitments. Objective: The aims of this study are to assess whether app-based mindfulness training can reduce anxiety in physicians and to explore if anxiety and burnout are correlated, thus leading to a reduction in both anxiety and burnout. Methods: This was a nonrandomized pilot study comprised of 34 physicians who worked in a large US health care network and reported having anxiety. The intervention was an app-based mindfulness program. The main outcome measure was anxiety, measured by the Generalized Anxiety Disorder-7 (GAD-7). The secondary outcome measures assessed burnout: cynicism and emotional exhaustion items from the Maslach Burnout Inventory. Results: GAD-7 scores decreased significantly at posttreatment (1 month after treatment initiation, 48% reduction, P<.001) and at the 3-month follow-up (57% reduction, P<.001). There was a significant correlation between anxiety and burnout (cynicism: r=.43; P=.01; emotional exhaustion: r=.71; P<.001). There was also a significant decrease in cynicism (50% reduction, P=.003 at posttreatment; 50% reduction, P=.009 at follow-up) and emotional exhaustion at both time points (20% reduction, P<.001 at posttreatment; 20% reduction, P=.003 at follow-up). Conclusions: This pilot study is the first to test an app-based mindfulness training program targeted at reducing anxiety with physicians and to demonstrate that in physicians, anxiety is correlated with burnout. These findings suggest that this may be an effective tool to reduce anxiety and burnout in physicians. Trial Registration: ClinicalTrials.gov NCT04137081; https://www.clinicaltrials.gov/ct2/show/NCT04137081 UR - https://mhealth.jmir.org/2020/4/e15608 UR - http://dx.doi.org/10.2196/15608 UR - http://www.ncbi.nlm.nih.gov/pubmed/32234708 ID - info:doi/10.2196/15608 ER - TY - JOUR AU - Seabrook, Elizabeth AU - Kelly, Ryan AU - Foley, Fiona AU - Theiler, Stephen AU - Thomas, Neil AU - Wadley, Greg AU - Nedeljkovic, Maja PY - 2020/3/18 TI - Understanding How Virtual Reality Can Support Mindfulness Practice: Mixed Methods Study JO - J Med Internet Res SP - e16106 VL - 22 IS - 3 KW - virtual reality KW - mindfulness KW - emotion KW - pilot projects KW - acceptability KW - evaluation N2 - Background: Regular mindfulness practice has been demonstrated to be beneficial for mental health, but mindfulness can be challenging to adopt, with environmental and personal distractors often cited as challenges. Virtual reality (VR) may address these challenges by providing an immersive environment for practicing mindfulness and by supporting the user to orient attention to the present moment within a tailored virtual setting. However, there is currently a limited understanding of the ways in which VR can support or hinder mindfulness practice. Such an understanding is required to design effective VR apps while ensuring that VR-supported mindfulness is acceptable to end users. Objective: This study aimed to explore how VR can support mindfulness practice and to understand user experience issues that may affect the acceptability and efficacy of VR mindfulness for users in the general population. Methods: A sample of 37 participants from the general population trialed a VR mindfulness app in a controlled laboratory setting. The VR app presented users with an omnidirectional video of a peaceful forest environment with a guided mindfulness voiceover that was delivered by a male narrator. Scores on the State Mindfulness Scale, Simulator Sickness Questionnaire, and single-item measures of positive and negative emotion and arousal were measured pre- and post-VR for all participants. Qualitative feedback was collected through interviews with a subset of 19 participants. The interviews sought to understand the user experience of mindfulness practice in VR. Results: State mindfulness (P<.001; Cohen d=1.80) and positive affect (P=.006; r=.45) significantly increased after using the VR mindfulness app. No notable changes in negative emotion, subjective arousal, or symptoms of simulator sickness were observed across the sample. Participants described the user experience as relaxing, calming, and peaceful. Participants suggested that the use of VR helped them to focus on the present moment by using visual and auditory elements of VR as attentional anchors. The sense of presence in the virtual environment (VE) was identified by participants as being helpful to practicing mindfulness. Interruptions to presence acted as distractors. Some uncomfortable experiences were discussed, primarily in relation to video fidelity and the weight of the VR headset, although these were infrequent and minor. Conclusions: This study suggests that an appropriately designed VR app can support mindfulness practice by enhancing state mindfulness and inducing positive affect. VR may help address the challenges of practicing mindfulness by creating a sense of presence in a tailored VE; by allowing users to attend to visual and auditory anchors of their choice; and by reducing the scope of the content in users? mind-wandering. VR has the unique capability to combine guided mindfulness practice with tailored VEs that lend themselves to support individuals to focus attention on the present moment. UR - http://www.jmir.org/2020/3/e16106/ UR - http://dx.doi.org/10.2196/16106 UR - http://www.ncbi.nlm.nih.gov/pubmed/32186519 ID - info:doi/10.2196/16106 ER - TY - JOUR AU - Ahmad, Farah AU - El Morr, Christo AU - Ritvo, Paul AU - Othman, Nasih AU - Moineddin, Rahim AU - PY - 2020/2/18 TI - An Eight-Week, Web-Based Mindfulness Virtual Community Intervention for Students? Mental Health: Randomized Controlled Trial JO - JMIR Ment Health SP - e15520 VL - 7 IS - 2 KW - mindfulness KW - CBT KW - depression KW - anxiety KW - students KW - universities KW - randomized controlled trial KW - Canada N2 - Background: Innovative interventions are needed to address the increasing mental health needs of university students. Given the demonstrated anxiolytic and antidepressant benefits of mindfulness training, we developed an 8-week, Web-based Mindfulness Virtual Community (MVC) intervention informed by cognitive behavioral therapy (CBT) constructs. Objective: This study investigated the efficacy of the MVC intervention in reducing symptoms of depression, anxiety, and stress among undergraduate students in Toronto, Canada. The secondary outcomes included quality of life, life satisfaction, and mindfulness. Methods: The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students? preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to video-based modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules. A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-face CBT; results for the latter group are presented elsewhere. Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting. The online surveys at baseline (T1), 4 weeks (T2), and 8 weeks (T3) included the Patient Health Questionnaire-9 item, Beck Anxiety Inventory, Perceived Stress Scale, Quality of Life Scale, Brief Multi-Dimensional Students Life Satisfaction Scale, and Five-Facet Mindfulness Questionnaire. Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible confounders (gender, age, birth country, paid work, unpaid work, physical activities, self-rated health, and mental health counseling access). Results: Of the 113 students who provided T1 data, 28 were males and 85 were females with a mean age of 24.8 years. Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39) groups were similar in sociodemographic characteristics at T1. At T3 follow-up, per adjusted comparisons, there were statistically significant reductions in depression scores for F-MVC (score change ?4.03; P<.001) and P-MVC (score change ?4.82; P<.001) when compared with WLC. At T3, there was a statistically significant reduction in anxiety scores only for P-MVC (score change ?7.35; P=.01) when compared with WLC. There was a statistically significant reduction in scores for perceived stress for both F-MVC (score change ?5.32; P<.001) and P-MVC (score change ?5.61; P=.005) compared with WLC. There were statistically significant changes at T3 for quality of life and mindfulness for F-MVC and P-MVC vs WLC but not for life satisfaction. Conclusions: Internet-based mindfulness CBT?based interventions, such as F-MVC and P-MVC, can result in significant reductions in symptoms of depression, anxiety, and stress in a student population. Future research with a larger sample from multiple universities would more precisely test generalizability. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275 UR - https://mental.jmir.org/2020/2/e15520 UR - http://dx.doi.org/10.2196/15520 UR - http://www.ncbi.nlm.nih.gov/pubmed/32074061 ID - info:doi/10.2196/15520 ER - TY - JOUR AU - Huberty, Jennifer AU - Puzia, Megan AU - Eckert, Ryan AU - Larkey, Linda PY - 2020/2/10 TI - Cancer Patients? and Survivors? Perceptions of the Calm App: Cross-Sectional Descriptive Study JO - JMIR Cancer SP - e16926 VL - 6 IS - 1 KW - cancer KW - cancer survivors KW - mindfulness KW - meditation KW - consumer behavior KW - mobile apps KW - health KW - mental health N2 - Background: There is a need for tools to decrease cancer patients? and survivors? long-term symptom burden. Complementary strategies, such as meditation, can accompany pharmacologic therapy to improve symptoms. Although support programs with targeted content have wider reach, higher adherence, and greater impact, there are no consumer-based meditation apps designed specifically for cancer. Objective: This study aimed to gather information to advise the development of a cancer-specific meditation app in a small convenience sample of cancer patients and survivors who currently use the Calm app. Methods: Adult cancer patients and survivors who are Calm users (N=82) were recruited through the Daily Calm Facebook page. Participants completed a Web-based survey related to Calm app use and satisfaction, interest in and ideas for a cancer-specific Calm app, and demographic characteristics. Open-ended responses were inductively coded. Results: Participants were aged between 18 and 72 years (mean 48.60 years, SD 15.20), mostly female (77/82, 94%), white (65/79, 82%), and non-Hispanic (70/75, 93%), and reported using Calm at least 5 times per week (49/82, 60%). Although rates of satisfaction with current Calm components were high (between 65/82, 79% and 51/81, 63%), only 49% (40/82) of participants used guided meditations that they felt specifically helped with their cancer-related symptoms and survivorship, and 40% (33/82) would prefer more cancer-related content, with guided meditations for cancer-specific anxieties (eg, fear of recurrence; n=15) and coping with strong emotions (n=12) being the most common suggestions. A majority of participants (51/82, 62%) reported that they would be interested in becoming a member of a Calm cancer community (eg, in-app discussion boards: 41/46, 89%; and social media communities: 35/42, 83%). Almost half of the participants (37/82, 45%) reported that they would benefit from features that tracked symptoms in concurrence with app usage, but respondents were divided on whether this information should be shared with health care providers through the app (49/82, 60% would share). Conclusions: Responses suggest ways in which the current Calm app could be adapted to better fit cancer patients? and survivors? needs and preferences, including adding cancer-specific content, increasing the amount of content focusing on coping with strong emotions, developing communities for Calm users who are cancer patients and survivors, and including features that track cancer-related symptoms. Given differences in opinions about which features were desirable or would be useful, there is a clear need for future cancer-specific apps to be customizable (eg, ability to turn different features on or off). Although future research should address these topics in larger, more diverse samples, these data will serve as a starting point for the development of cancer-specific meditation apps and provide a framework for evaluating their effects. UR - http://cancer.jmir.org/2020/1/e16926/ UR - http://dx.doi.org/10.2196/16926 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/16926 ER - TY - JOUR AU - Hewawasam, Erandi AU - Brennan, Leah AU - Giles, Lynne AU - Hull, Louise Mary AU - Short, Asha AU - Norman, Robert AU - Peña, S. Alexia PY - 2020/1/28 TI - Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e14542 VL - 9 IS - 1 KW - meditation KW - quality of life KW - polycystic ovary syndrome KW - adolescent N2 - Background: Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents. Objective: This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS. Methods: This study is a randomized controlled trial that will be conducted over eight weeks at the Women?s and Children?s Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels. Results: The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure. Conclusions: This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&amp;isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/14542 UR - https://www.researchprotocols.org/2020/1/e14542 UR - http://dx.doi.org/10.2196/14542 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012099 ID - info:doi/10.2196/14542 ER - TY - JOUR AU - Parsons, E. Christine AU - Madsen, A. Maria AU - Jensen, Løvborg Kasper AU - Kæseler, Simon AU - Fjorback, Overby Lone AU - Piet, Jacob AU - Roepstorff, Andreas AU - Linehan, Conor PY - 2020/1/14 TI - Smartphone Monitoring of Participants? Engagement With Home Practice During Mindfulness-Based Stress Reduction: Observational Study JO - JMIR Ment Health SP - e14467 VL - 7 IS - 1 KW - mindfulness KW - adherence KW - smartphone monitoring KW - meditation practice KW - habit formation N2 - Background: Standardized mindfulness training courses involve significant at-home assignments of meditation practice. Participants? self-reported completion of these assignments has been correlated with treatment outcomes, but self-reported data are often incomplete and potentially biased. In addition, mindfulness teachers typically suggest that participants set aside a regular practice time, preferably in the morning, but the extent to which participants do this has not been empirically examined. Objective: This study aimed to analyze patterns of participant engagement with home practice in a mindfulness-based stress reduction course. Methods: We used a novel smartphone app to provide 25 participants with access to their daily practice assignments during the 8-week course. We analyzed data collected through our smartphone app to determine usage and listening patterns and performed analyses of the regularity and frequency of participant behavior. Results: We found that participants listened to a median of 3 of the 6 practice sessions per week, and they did not typically set aside a regular daily practice time. Across weekdays, participants practiced most frequently in the morning, but there was considerable variation in participants? practice start times. On weekends, the peak practice time was in the evening. Conclusions: We suggest that it is feasible to integrate a smartphone-monitoring approach into existing mindfulness interventions. High-frequency smartphone monitoring can provide insights into how and when participants complete their homework, information that is important in supporting treatment engagement. UR - https://mental.jmir.org/2020/1/e14467 UR - http://dx.doi.org/10.2196/14467 UR - http://www.ncbi.nlm.nih.gov/pubmed/31934873 ID - info:doi/10.2196/14467 ER - TY - JOUR AU - Azam, Abid Muhammad AU - Latman, Valeria Vered AU - Katz, Joel PY - 2019/12/2 TI - Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e14119 VL - 8 IS - 12 KW - mindfulness KW - mobile apps KW - heart rate variability KW - chronic pain KW - depression KW - anxiety N2 - Background: Mindfulness meditation (MM) is a commonly used psychological intervention for pain, mood, and anxiety conditions, but can be challenging to practice with severe symptoms without proper training. The Mindfulness Meditation app (MMA) is a supportive training tool specifically developed for this study to aid in the practice of mindful breathing using a smartphone. Objective: This study aims to evaluate the psychophysiological effects of the MMA. Specifically, the study will assess parasympathetic functioning using heart rate variability (HRV; primary outcome), pain and mood symptoms, mind-wandering and present moment awareness, and breath focus in groups of undergraduate participants who self-report clinically-relevant symptoms of chronic pain (CP) and depression or anxiety (DA) and condition-free (CF) participants who do not meet either criteria. We hypothesize that use of the MMA by study groups will lead to improved HRV, pain, and mood symptoms compared with groups who do not use the app. Methods: This study is a two-arm randomized controlled trial (RCT) recruiting through a Web-based research participation pool at York University in Toronto, Canada. We are aiming for minimum 60 participants in each of CP, DA, and CF groups. Upon arriving to the laboratory, participants will be prescreened for classification into groups of CP, DA, or CF. Groups will be randomly assigned by a 1:1 ratio to an MMA (MMA+) condition or MM condition without the app (MMA?) after a brief stress induction procedure. In MMA+, participants will practice mindful breathing with a smartphone and press breath or other buttons at the sound of audio tones if their awareness was on breathing or another experience, respectively. HRV and respiration data will be obtained during rest (5 min), stress induction (5 min), and meditation conditions (12 min). Participants will complete psychological self-report inventories before and after the stress induction and after the meditation condition. Separate linear mixed models will be used to examine HRV and self-report inventories comparing groups and treatment conditions. Results: Recruitment for the study began in November 2017 and is expected to be completed in winter of 2019-2020. As of July 2019, 189 participants have been recruited. The study?s main findings are expected to reveal a positive pattern of HRV responses in the CP, DA, and CF groups, such that a significant increase in HRV (P<.05) is detected in those randomized to the MMA+ condition in comparison with those randomized to the MMA? condition. Conclusions: This RCT will contribute to the burgeoning health psychology literature regarding the clinical relevance of HRV in assessment and treatment of psychological and medical conditions. Furthermore, possible ways to inform designs of MM training tools delivered by apps and Web platforms for CP, depression, and anxiety conditions? treatment will be discussed. Trial Registration: Clinicaltrials.gov NCT03296007; https://clinicaltrials.gov/ct2/show/NCT03296007. International Registered Report Identifier (IRRID): DERR1-10.2196/14119 UR - https://www.researchprotocols.org/2019/12/e14119 UR - http://dx.doi.org/10.2196/14119 UR - http://www.ncbi.nlm.nih.gov/pubmed/31789601 ID - info:doi/10.2196/14119 ER - TY - JOUR AU - Lippmann, Marie AU - Laudel, Helena AU - Heinzle, Marlene AU - Narciss, Susanne PY - 2019/11/27 TI - Relating Instructional Design Components to the Effectiveness of Internet-Based Mindfulness Interventions: A Critical Interpretive Synthesis JO - J Med Internet Res SP - e12497 VL - 21 IS - 11 KW - mindfulness KW - internet KW - instructional design N2 - Background: Internet-based mindfulness interventions are a promising approach to address challenges in the dissemination and implementation of mindfulness interventions, but it is unclear how the instructional design components of such interventions are associated with intervention effectiveness. Objective: The objective of this study was to identify the instructional design components of the internet-based mindfulness interventions and provide a framework for the classification of those components relative to the intervention effectiveness. Methods: The critical interpretive synthesis method was applied. In phase 1, a strategic literature review was conducted to generate hypotheses for the relationship between the effectiveness of internet-based mindfulness interventions and the instructional design components of those interventions. In phase 2, the literature review was extended to systematically explore and revise the hypotheses from phase 1. Results: A total of 18 studies were identified in phase 1; 14 additional studies were identified in phase 2. Of the 32 internet-based mindfulness interventions, 18 were classified as more effective, 11 as less effective, and only 3 as ineffective. The effectiveness of the interventions increased with the level of support provided by the instructional design components. The main difference between effective and ineffective interventions was the presence of just-in-time information in the form of reminders. More effective interventions included more supportive information (scores: 1.91 in phases 1 and 2) than less effective interventions (scores: 1.00 in phase 1 and 1.80 in phase 2), more part-task practice (scores: 1.18 in phase 1 and 1.60 in phase 2) than less effective interventions (scores: 0.33 in phase 1 and 1.40 in phase 2), and provided more just-in-time information (scores: 1.35 in phase 1 and 1.67 in phase 2) than less effective interventions (scores: 0.83 in phase 1 and 1.60 in phase 2). The average duration of more effective, less effective, and ineffective interventions differed for the studies of phase 1, with more effective interventions taking up more time (7.45 weeks) than less effective (4.58 weeks) or ineffective interventions (3 weeks). However, this difference did not extend to the studies of phase 2, with comparable average durations of effective (5.86 weeks), less effective (5.6 weeks), and ineffective (7 weeks) interventions. Conclusions: Our results suggest that to be effective, internet-based mindfulness interventions must contain 4 instructional design components: formal learning tasks, supportive information, part-task practice, and just-in-time information. The effectiveness of the interventions increases with the level of support provided by each of these instructional design components. UR - http://www.jmir.org/2019/11/e12497/ UR - http://dx.doi.org/10.2196/12497 UR - http://www.ncbi.nlm.nih.gov/pubmed/31774413 ID - info:doi/10.2196/12497 ER - TY - JOUR AU - Bao, Ting AU - Deng, Gary AU - DeMarzo, A. Lauren AU - Zhi, Iris W. AU - DeRito, L. Janice AU - Blinder, Victoria AU - Chen, Connie AU - Li, S. Qing AU - Green, Jamie AU - Pendleton, Eva AU - Mao, J. Jun PY - 2019/11/7 TI - A Technology-Assisted, Brief Mind-Body Intervention to Improve the Waiting Room Experience for Chemotherapy Patients: Randomized Quality Improvement Study JO - JMIR Cancer SP - e13217 VL - 5 IS - 2 KW - mobile app KW - acupressure KW - meditation KW - symptom relief KW - chemotherapy N2 - Background: Patients waiting for chemotherapy can experience stress, anxiety, nausea, and pain. Acupressure and meditation have been shown to control such symptoms. Objective: This study aimed to evaluate the feasibility and effectiveness of an integrative medicine app to educate patients about these self-care tools in chemotherapy waiting rooms. Methods: We screened and enrolled cancer patients in chemotherapy waiting rooms at two Memorial Sloan Kettering Cancer Center locations. Patients were randomly assigned into an intervention arm in which subjects watched acupressure and meditation instructional videos or a control arm in which they watched a time- and attention-matched integrative oncology lecture video. Before and after watching the videos, we asked the patients to rate four key symptoms: stress, anxiety, nausea, and pain. We performed the analysis of covariance to detect differences between the two arms postintervention while controlling for baseline symptoms. Results: A total of 223 patients were enrolled in the study: 113 patients were enrolled in the intervention arm and 110 patients were enrolled in the control arm. In both groups, patients showed significant reductions in stress and anxiety from baseline (all P<.05), with the treatment arm reporting greater stress and anxiety reduction than the control arm (1.64 vs 1.15 in stress reduction; P=.01 and 1.39 vs 0.78 in anxiety reduction; P=.002). The majority of patients reported that the videos helped them pass time and that they would watch the videos again. Conclusions: An integrative medicine self-care app in the waiting room improved patients? experiences and reduced anxiety and stress. Future research could focus on expanding this platform to other settings to improve patients? overall treatment experiences. UR - http://cancer.jmir.org/2019/2/e13217/ UR - http://dx.doi.org/10.2196/13217 UR - http://www.ncbi.nlm.nih.gov/pubmed/31697238 ID - info:doi/10.2196/13217 ER - TY - JOUR AU - Huberty, Jennifer AU - Vranceanu, Ana-Maria AU - Carney, Colleen AU - Breus, Michael AU - Gordon, Michael AU - Puzia, Elizabeth Megan PY - 2019/11/3 TI - Characteristics and Usage Patterns Among 12,151 Paid Subscribers of the Calm Meditation App: Cross-Sectional Survey JO - JMIR Mhealth Uhealth SP - e15648 VL - 7 IS - 11 KW - health KW - psychological stress KW - sleep KW - mindfulness KW - meditation KW - consumer behavior KW - mobile health KW - mhealth KW - digital health N2 - Background: Meditation has become increasingly popular due to its health benefits; however, barriers to delivering meditation programs in traditional group-based formats limit the accessibility of these benefits. Smartphone-based meditation may increase the availability of these programs to larger, more diverse audiences; however, research on subscriber characteristics and usage patterns in meditation mobile apps is lacking. Objective: This study aimed to describe the demographics, clinical characteristics, and usage patterns of a convenience sample of Calm subscribers and explore the relationship between self-reported app usage and changes in health, stress, and sleep. Methods: Participants were 12,151 paying Calm subscribers (response rate=12.08%, 12,151/100,594) who completed an anonymous Web-based survey with 11 quantitative questions related to user engagement, reasons for starting Calm, and changes after using the app. Demographic characteristics, chronic health diagnoses, and sleep difficulties were also assessed. Chi-square tests were used to examine differences in app usage. Logistic regression models were used to examine demographic and health characteristics that may predict changes in health, stress, and sleep. Results: Respondents were 18-96 years old (mean 48.57 [SD 13.79]), primarily female (79.94%, 8778/10,981), white (81.41%, 8959/11,005), and most reported a chronic health diagnosis (56.86%, 6289/11,061). Mental health diagnoses (41.13%, 4549/11,061) were more common than physical health diagnoses (32.19%, 3560/11,061). Most respondents (76.31%, 8684/11,360) reported difficulties falling or staying asleep. On average, respondents had been using Calm for 11.49 months (SD 10.49), and 60.03% (7281/12,129) used it 5 or more times per week. Meditations (used by 80.02%, 9497/11,841) and Sleep Stories (55.66%, 6591/11,841) were the most popular components. The frequency of using Calm was associated with incremental increases in the likelihood of noticing changes in mental health (?22=136.8; P<.001), physical health (?22=102.8; P<.001), stress (?22=128.1; P<.001), and sleep (?22=141.4; P<.001). Respondents who had used Calm longer were also more likely to notice changes in mental health (OR 1.06 [95% CI 1.05 to 1.06]), physical health (OR 1.01 [95% CI 1.01 to 1.02]), stress (OR 1.04 [95% CI 1.04 to 1.05]), and sleep (OR 1.004 [95% CI 1.00 to 1.01]). Subscribers with sleep difficulties used Calm more frequently (?82=11.5; P=.003), were more likely to use Sleep Stories (?12=1590.2; P<.001), and were more likely to notice changes in their physical health (?12=49.2; P<.001) and sleep (?12=2391.1; P<.001). Conclusions: Results highlight important demographic characteristics and usage patterns among a self-selected sample of Calm subscribers. Mental health concerns and sleep appear to be top reasons for downloading Calm. Sleep Stories and meditations are the most popular app components. The frequency of using Calm was associated with incremental changes in outcomes. Findings support future randomized controlled trials testing the efficacy of Calm for health, stress, and sleep. Studies should also explore strategies to attract a more diverse sample of subscribers. UR - https://mhealth.jmir.org/2019/11/e15648 UR - http://dx.doi.org/10.2196/15648 UR - http://www.ncbi.nlm.nih.gov/pubmed/31682582 ID - info:doi/10.2196/15648 ER - TY - JOUR AU - Lyzwinski, Nathalie Lynnette AU - Edirippulige, Sisira AU - Caffery, Liam AU - Bambling, Matthew PY - 2019/08/22 TI - Mindful Eating Mobile Health Apps: Review and Appraisal JO - JMIR Ment Health SP - e12820 VL - 6 IS - 8 KW - feeding behavior KW - mindfulness KW - mHealth KW - diet N2 - Background: Mindful eating is an emerging area of research for managing unhealthy eating and weight-related behaviors such as binge eating and emotional eating. Although there are numerous commercial mindful eating apps available, their quality, effectiveness, and whether they are accurately based on mindfulness-based eating awareness are unknown. Objective: This review aimed to appraise the quality of the mindful eating apps and to appraise the quality of content on mindful eating apps. Methods: A review of mindful eating apps available on Apple iTunes was undertaken from March to April 2018. Relevant apps meeting the inclusion criteria were subjectively appraised for general app quality using the Mobile App Rating Scale (MARS) guidelines and for the quality of content on mindful eating. A total of 22 apps met the inclusion criteria and were appraised. Results: Many of the reviewed apps were assessed as functional and had moderate scores in aesthetics based on the criteria in the MARS assessment. However, some received lower scores in the domains of information and engagement. The majority of the apps did not teach users how to eat mindfully using all five senses. Hence, they were scored as incomplete in accurately providing mindfulness-based eating awareness. Instead, most apps were either eating timers, hunger rating apps, or diaries. Areas of potential improvement were in comprehensiveness and diversity of media, in the quantity and quality of information, and in the inclusion of privacy and security policies. To truly teach mindful eating, the apps need to provide guided examples involving the five senses beyond simply timing eating or writing in a diary. They also need to include eating meditations to assist people with their disordered eating such as binge eating, fullness, satiety, and craving meditations that may help them with coping when experiencing difficulties. They should also have engaging and entertaining features delivered through diverse media to ensure sustained use and interest by consumers. Conclusions: Future mindful eating apps could be improved by accurate adherence to mindful eating. Further improvement could be achieved by ameliorating the domains of information, engagement, and aesthetics and having adequate privacy policies. UR - https://mental.jmir.org/2019/8/e12820/ UR - http://dx.doi.org/10.2196/12820 UR - http://www.ncbi.nlm.nih.gov/pubmed/31441431 ID - info:doi/10.2196/12820 ER - TY - JOUR AU - Jabson Tree, M. Jennifer AU - Patterson, Gayle Joanne PY - 2019/08/16 TI - A Test of Feasibility and Acceptability of Online Mindfulness-Based Stress Reduction for Lesbian, Gay, and Bisexual Women and Men at Risk for High Stress: Pilot Study JO - JMIR Ment Health SP - e15048 VL - 6 IS - 8 KW - sexual minority KW - lesbian KW - gay KW - bisexual KW - psychological stress N2 - Background: In conservative and rural areas, where antidiscrimination laws do not exist, lesbian, gay, and bisexual (LGB) people are at risk for excess stress arising from discrimination. Stress-reducing interventions delivered via innovative channels to overcome access barriers are needed. Objective: This study aimed to investigate the feasibility and acceptability of online mindfulness-based stress reduction (OMBSR) with LGB people in Appalachian Tennessee at high risk for stress. Methods: In 2 pilot studies involving pre-post test designs, participants completed 8 weeks of OMBSR, weekly activity logs, semistructured interviews, and surveys of perceived and minority stress. Results: Overall, 24 LGB people enrolled in the study and 17 completed OMBSR. In addition, 94% completed some form of mindfulness activities daily, including meditation. Participants enjoyed the program and found it easy to use. Perceived stress (Cohen, perceived stress scale-10) decreased by 23% in women (mean 22.73 vs mean 17.45; t10=3.12; P=.01) and by 40% in men (mean 19.83 vs mean 12.00; t5=3.90; P=.01) between baseline and postprogram. Women demonstrated a 12% reduction in overall minority stress (Balsam, Daily Experiences with Heterosexism Questionnaire) from baseline to 12-week follow-up (mean 1.87 vs mean 1.57; t10=4.12; P=.002). Subscale analyses indicated that women?s stress due to vigilance and vicarious trauma decreased by 21% and 20%, respectively. Conclusions: OMBSR may be a useful tool to help LGB people reduce general and minority-specific stress in socially conservative regions lacking antidiscrimination policies. UR - http://mental.jmir.org/2019/8/e15048/ UR - http://dx.doi.org/10.2196/15048 UR - http://www.ncbi.nlm.nih.gov/pubmed/31420955 ID - info:doi/10.2196/15048 ER - TY - JOUR AU - Ewais, Tatjana AU - Begun, Jakob AU - Kenny, Maura AU - Headey, Alan AU - Kisely, Steve PY - 2019/07/24 TI - Mindfulness-Based Cognitive Therapy Experiences in Youth With Inflammatory Bowel Disease and Depression: Protocol for a Mixed Methods Qualitative Study JO - JMIR Res Protoc SP - e14432 VL - 8 IS - 7 KW - mindfulness KW - inflammatory bowel disease KW - qualitative research KW - adolescents KW - young adults N2 - Background: Mindfulness-based programs are increasingly used as a part of integrated treatment for inflammatory bowel disease (IBD). However, the majority of research has been quantitative with limited qualitative exploration of patients? experiences of mindfulness programs and no studies among adolescents and young adults with IBD. Furthermore, there has been a paucity of research exploring the role of common psychotherapy and group factors within mindfulness programs. Objective: This study aims to explore the experiences of adolescents and young adults with IBD and depression who completed a mindfulness-based cognitive therapy (MBCT) group program, as well as the role of therapeutic alliance, group affiliation, and other common psychotherapy and group factors. Methods: This mixed methods qualitative study, nested within a randomized controlled trial (RCT) of MBCT for adolescents and young adults with IBD, will obtain qualitative data from focus groups and open-ended survey questions. The study aims to conduct three to four focus groups with 6-8 participants in each group. It will employ data and investigator triangulation as well as thematic analysis of the qualitative data. Results: The study was approved by the Mater Hospital Human Research Ethics Committee and recruitment commenced in May 2019; study completion is anticipated by early 2020. Conclusions: The study will contribute to the assessment of acceptability and feasibility of the MBCT program for adolescents and young adults with IBD. It will also elucidate the role of previously unexplored common psychotherapy and group factors within mindfulness training and help inform the design of a future large-scale RCT of MBCT in this cohort. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617000876392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373115 International Registered Report Identifier (IRRID): PRR1-10.2196/14432 UR - http://www.researchprotocols.org/2019/7/e14432/ UR - http://dx.doi.org/10.2196/14432 UR - http://www.ncbi.nlm.nih.gov/pubmed/31342900 ID - info:doi/10.2196/14432 ER - TY - JOUR AU - Huberty, Jennifer AU - Eckert, Ryan AU - Larkey, Linda AU - Joeman, Lynda AU - Mesa, Ruben PY - 2019/07/22 TI - Experiences of Using a Consumer-Based Mobile Meditation App to Improve Fatigue in Myeloproliferative Patients: Qualitative Study JO - JMIR Cancer SP - e14292 VL - 5 IS - 2 KW - mindfulness KW - meditation KW - mobile phone KW - mHealth KW - digital health KW - cancer N2 - Background: Myeloproliferative neoplasm (MPN) patients suffer from long-term symptoms and reduced quality of life. Mindfulness meditation is a complementary therapy shown to be beneficial for alleviating a range of cancer-related symptoms; however, in-person meditation interventions are difficult for cancer patients to attend. Meditation via a mobile phone app represents a novel approach in MPN patients for delivering meditation. Objective: The study aimed to report MPN patients? (ie, naïve or nearly naïve meditators) perceptions of meditation and explore their experiences in the context of using a mobile phone for meditation after participation in an 8-week consumer-based meditation app feasibility study. Methods: MPN patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 that received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min per day of mobile phone-based meditation, irrespective of the app and order in which they received the apps. At the conclusion of the study, participants were asked whether they would like to participate in a 20-min phone interview comprising 9 to 10 questions to discuss their perceptions and experiences while using the mobile phone meditation apps. The interviews were transcribed verbatim and imported into NVivo 12 (QSR International) for coding and analysis, using a combination of deductive and inductive methods to organize the data, generate categories, and develop themes and subthemes. Results: A total of 48 MPN patients completed postintervention interviews, of which 29% (14/48) of the patients only used the 10% Happier app, 21% (10/48) of the patients only used the Calm app, and 46% (22/48) of the patients used both apps during the 8-week intervention. Themes identified in the analysis of interview data related to (1) perceptions of meditation before, during, and after the study, (2) perceptions of the Calm app, (3) perceptions of the 10% Happier app, (4) perceived impacts of using the meditation apps, (5) overall experiences of participating in the study, (6) recommendations surrounding meditation for other MPN patients, and (7) plans to continue meditation. Conclusions: The qualitative findings of this study suggest that MPN patients who are naïve or nearly naïve meditators perceived mobile phone meditation as enjoyable, preferred the Calm app over the 10% Happier app, perceived the Calm app as more appealing (eg, narrator?s voice and different meditations or background sounds offered), and perceived beneficial effects of meditation on mental health, sleep, fatigue, and pain. Future research is needed to better understand the efficacy of mobile phone meditation on MPN patient outcomes and meditation app design features that enhance uptake among its users. UR - http://cancer.jmir.org/2019/2/e14292/ UR - http://dx.doi.org/10.2196/14292 UR - http://www.ncbi.nlm.nih.gov/pubmed/31333197 ID - info:doi/10.2196/14292 ER - TY - JOUR AU - Collins, Emily AU - Cox, Anna AU - Wilcock, Caroline AU - Sethu-Jones, Geraint PY - 2019/07/18 TI - Digital Games and Mindfulness Apps: Comparison of Effects on Post Work Recovery JO - JMIR Ment Health SP - e12853 VL - 6 IS - 7 KW - play KW - occupational health KW - mindfulness N2 - Background: Engagement in activities that promote the dissipation of work stress is essential for post work recovery and consequently for well-being. Previous research suggests that activities that are immersive, active, and engaging are especially effective at promoting recovery. Therefore, digital games may be able to promote recovery, but little is known about how they compare with other popular mobile activities, such as mindfulness apps that are specifically designed to support well-being. Objective: The aim of this study was to investigate and compare the effectiveness of a digital game and mindfulness app in promoting post work recovery, first in a laboratory setting and then in a field study. Methods: Study 1 was a laboratory experiment (n=45) in which participants? need for recovery was induced by a work task, before undertaking 1 of 3 interventions: a digital game (Block! Hexa Puzzle), a mindfulness app (Headspace), or a nonmedia control with a fidget spinner (a physical toy). Recovery in the form of how energized participants felt (energetic arousal) was compared before and after the intervention and how recovered participants felt (recovery experience) was compared across the conditions. Study 2 was a field study with working professionals (n=20), for which participants either played the digital game or used the mindfulness app once they arrived home after work for a period of 5 working days. Measures of energetic arousal were taken before and after the intervention, and the recovery experience was measured after the intervention along with measures of enjoyment and job strain. Results: A 3×2 mixed analysis of variance identified that, in study 1, the digital game condition increased energetic arousal (indicative of improved recovery) whereas the other 2 conditions decreased energetic arousal (F2,42=3.76; P=.03). However, there were no differences between the conditions in recovery experience (F2,42=.01; P=.99). In study 2, multilevel model comparisons identified that neither the intervention nor day of the week had a significant main effect on how energized participants felt. However, for those in the digital game condition, daily recovery experience increased during the course of the study, whereas for those in the mindfulness condition, it decreased (F1,18=9.97; P=.01). Follow-up interviews with participants identified 3 core themes: detachment and restoration, fluctuations and differences, and routine and scheduling. Conclusions: This study suggests that digital games may be effective in promoting post work recovery in laboratory contexts (study 1) and in the real world, although the effect in this case may be cumulative rather than instant (study 2). UR - http://mental.jmir.org/2019/7/e12853/ UR - http://dx.doi.org/10.2196/12853 UR - http://www.ncbi.nlm.nih.gov/pubmed/31322125 ID - info:doi/10.2196/12853 ER - TY - JOUR AU - Huberty, Jennifer AU - Green, Jeni AU - Glissmann, Christine AU - Larkey, Linda AU - Puzia, Megan AU - Lee, Chong PY - 2019/06/25 TI - Efficacy of the Mindfulness Meditation Mobile App ?Calm? to Reduce Stress Among College Students: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e14273 VL - 7 IS - 6 KW - meditation KW - mental health KW - mindfulness KW - smartphone KW - technology KW - mobile phone N2 - Background: College students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students. Objective: We aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app?Calm?compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention?s effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app. Methods: This study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ?14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ?.05 was considered statistically significant. Results: A total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up. Conclusions: Calm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs. Trial Registration: ClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810 UR - http://mhealth.jmir.org/2019/6/e14273/ UR - http://dx.doi.org/10.2196/14273 UR - http://www.ncbi.nlm.nih.gov/pubmed/31237569 ID - info:doi/10.2196/14273 ER - TY - JOUR AU - Spears, Adams Claire AU - Abroms, C. Lorien AU - Glass, R. Carol AU - Hedeker, Donald AU - Eriksen, P. Michael AU - Cottrell-Daniels, Cherell AU - Tran, Q. Binh AU - Wetter, W. David PY - 2019/06/24 TI - Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e13059 VL - 7 IS - 6 KW - text messaging KW - smoking cessation KW - low-income populations N2 - Background: Mindfulness training shows promise for improving smoking cessation and lapse recovery, and between-session mobile health messages could enhance treatment engagement and effectiveness. Personalized, in-the-moment text messaging support could be particularly useful for low-income smokers with fewer smoking cessation resources. Objective: This pilot study examined the feasibility of a text messaging program (iQuit Mindfully) as an adjunct to in-person Mindfulness-Based Addiction Treatment (MBAT) for smoking cessation. Methods: A total of 71 participants were randomly assigned to MBAT (n=33) or iQuit Mindfully (n=38; MBAT + between-session text messages); of these, 70% (50/71) were African American, and 61% (43/71) had an annual household income of US $30,000 or less. All participants received 8 weekly therapist-led group counseling sessions, nicotine patches, and self-help materials. Outcomes were feasibility (attrition, engagement, and participants? ratings), participants? feedback regarding the text messaging intervention, and smoking cessation (assessed in person). Results: Strong retention was achieved (76% [54/71] at the end of treatment, and 89% [63/71] at 1-month follow-up). In the iQuit Mindfully group, engagement was high (88% [29/33] indicated reading all or most texts, and 89% [34/38] engaged in interactive texting), and participants provided positive ratings (on a 1-10 scale, average rating for recommending the program to others was 8.4 [SD 2.5]). Participants indicated benefiting from the texts (eg, appreciating encouraging reminders, coping strategies, and social support) and suggested improvements (eg, more personalization). Overall, biochemically confirmed smoking cessation rates were 22% (12/55) at the end of treatment and 19% (12/62) at 1-month follow-up, with no differences between conditions. Living below the poverty level predicted worse cessation outcomes at 1-month follow-up among participants receiving in-person only treatment (P=.03) but not among those receiving iQuit Mindfully. Conclusions: Text messaging appears to be a feasible and acceptable modality for supporting mindfulness-based smoking cessation treatment. The availability of 24/7 text messaging might be particularly helpful for low-income smokers who have access to fewer cessation resources and experience significant day-to-day barriers to quitting. Trial Registration: ClinicalTrials.gov NCT03029819; https://clinicaltrials.gov/ct2/show/NCT03029819 UR - http://mhealth.jmir.org/2019/6/e13059/ UR - http://dx.doi.org/10.2196/13059 UR - http://www.ncbi.nlm.nih.gov/pubmed/31237242 ID - info:doi/10.2196/13059 ER - TY - JOUR AU - Kerr, C. Darragh AU - Ornelas, J. India AU - Lilly, M. Michelle AU - Calhoun, Rebecca AU - Meischke, Hendrika PY - 2019/06/19 TI - Participant Engagement in and Perspectives on a Web-Based Mindfulness Intervention for 9-1-1 Telecommunicators: Multimethod Study JO - J Med Internet Res SP - e13449 VL - 21 IS - 6 KW - occupational stress KW - occupational health KW - mental health KW - mindfulness KW - telecommunications N2 - Background: Demanding working conditions and secondary exposure to trauma may contribute to a high burden of stress among 9-1-1 telecommunicators, decreasing their ability to work effectively and efficiently. Web-based mindfulness-based interventions (MBIs) can be effective in reducing stress in similar populations. However, low engagement may limit the effectiveness of the intervention. Objective: The aim of this study was to assess participant engagement in a Web-based MBI designed for 9-1-1 telecommunicators. Specifically, we sought to describe the following: (1) participant characteristics associated with intervention engagement, (2) participant perspectives on engaging with the intervention, and (3) perceived challenges and facilitators to engaging. Methods: We used qualitative and quantitative data from participant surveys (n=149) that were collected to assess the efficacy of the intervention. We conducted descriptive and bivariate analyses to identify associations between demographic, psychosocial, and workplace characteristics and engagement. We conducted a thematic analysis of qualitative survey responses to describe participant experiences with the MBI. Results: We found that no individual participant characteristics were associated with the level of engagement (low vs high number of lessons completed). Participant engagement did vary by the call center (P<.001). We identified the following overarching qualitative themes: (1) the participants perceived benefits of mindfulness practice, (2) the participants perceived challenges to engage with mindfulness and the intervention, and (3) intervention components that facilitated engagement. The participants expressed positive beliefs in the perceived benefits of practicing mindfulness, including increased self-efficacy in coping with stressors and increased empathy with callers. The most commonly cited barriers were work-related, particularly not having time to participate in the intervention at work. Facilitators included shorter meditation practices and the availability of multiple formats and types of intervention content. Conclusions: The findings of this study suggest that efforts to improve intervention engagement should focus on organizational-level factors rather than individual participant characteristics. Future research should explore the effect of mindfulness practice on the efficiency and effectiveness of 9-1-1 telecommunicators at work. Trial Registration: ClinicalTrials.gov NCT02961621; https://clinicaltrials.gov/ct2/show/NCT02961621 UR - http://www.jmir.org/2019/6/e13449/ UR - http://dx.doi.org/10.2196/13449 UR - http://www.ncbi.nlm.nih.gov/pubmed/31219045 ID - info:doi/10.2196/13449 ER - TY - JOUR AU - Athanas, J. Argus AU - McCorrison, M. Jamison AU - Smalley, Susan AU - Price, Jamie AU - Grady, Jim AU - Wehner, Paul AU - Campistron, Julie AU - Schork, J. Nicholas PY - 2019/05/08 TI - Association Between Improvement in Baseline Mood and Long-Term Use of a Mindfulness and Meditation App: Observational Study JO - JMIR Ment Health SP - e12617 VL - 6 IS - 5 KW - mental health KW - smartphone KW - emotional well-being KW - mindfulness N2 - Background: The use of smartphone apps to monitor and deliver health care guidance and interventions has received considerable attention recently, particularly with regard to behavioral disorders, stress relief, negative emotional state, and poor mood in general. Unfortunately, there is little research investigating the long-term and repeated effects of apps meant to impact mood and emotional state. Objective: We aimed to investigate the effects of both immediate point-of-intervention and long-term use (ie, at least 10 engagements) of a guided meditation and mindfulness smartphone app on users? emotional states. Data were collected from users of a mobile phone app developed by the company Stop, Breathe & Think (SBT) for achieving emotional wellness. To explore the long-term effects, we assessed changes in the users? basal emotional state before they completed an activity (eg, a guided meditation). We also assessed the immediate effects of the app on users? emotional states from preactivity to postactivity. Methods: The SBT app collects information on the emotional state of the user before and after engagement in one or several mediation and mindfulness activities. These activities are recommended and provided by the app based on user input. We considered data on over 120,000 users of the app who collectively engaged in over 5.5 million sessions with the app during an approximate 2-year period. We focused our analysis on users who had at least 10 engagements with the app over an average of 6 months. We explored the changes in the emotional well-being of individuals with different emotional states at the time of their initial engagement with the app using mixed-effects models. In the process, we compared 2 different methods of classifying emotional states: (1) an expert-defined a priori mood classification and (2) an empirically driven cluster-based classification. Results: We found that among long-term users of the app, there was an association between the length of use and a positive change in basal emotional state (4% positive mood increase on a 2-point scale every 10 sessions). We also found that individuals who were anxious or depressed tended to have a favorable long-term emotional transition (eg, from a sad emotional state to a happier emotional state) after using the app for an extended period (the odds ratio for achieving a positive emotional state was 3.2 and 6.2 for anxious and depressed individuals, respectively, compared with users with fewer sessions). Conclusions: Our analyses provide evidence for an association between both immediate and long-term use of an app providing guided meditations and improvements in the emotional state. UR - https://mental.jmir.org/2019/5/e12617/ UR - http://dx.doi.org/10.2196/12617 UR - http://www.ncbi.nlm.nih.gov/pubmed/31066704 ID - info:doi/10.2196/12617 ER - TY - JOUR AU - Huberty, Jennifer AU - Eckert, Ryan AU - Larkey, Linda AU - Kurka, Jonathan AU - Rodríguez De Jesús, A. Sue AU - Yoo, Wonsuk AU - Mesa, Ruben PY - 2019/04/29 TI - Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials JO - JMIR Form Res SP - e12662 VL - 3 IS - 2 KW - mindfulness KW - meditation KW - smartphone KW - mHealth KW - cancer KW - quality of life N2 - Background: Myeloproliferative neoplasm (MPN) patients often report high symptom burden that persists despite the best available pharmacologic therapy. Meditation has gained popularity in recent decades as a way to manage cancer patient symptoms. Objective: The aim of this study was to examine the feasibility of 2 different consumer-based meditation smartphone apps in MPN patients and to examine the limited efficacy of smartphone-based meditation on symptoms compared with an educational control group. Methods: Patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 of which received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min of meditation per day irrespective of the app and the order in which they received the apps. Feasibility outcomes were measured at weeks 5 and 9 with a Web-based survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. Results: A total of 128 patients were enrolled across all 4 groups, with 73.4% (94/128) patients completing the intervention. Of the participants who completed the 10% Happier app, 61% (46/76) enjoyed it, 66% (50/76) were satisfied with the content, and 77% (59/76) would recommend to others. Of those who completed the Calm app, 83% (56/68) enjoyed it, 84% (57/68) were satisfied with the content, and 97% (66/68) would recommend to others. Of those who completed the educational control, 91% (56/61) read it, 87% (53/61) enjoyed it, and 71% (43/61) learned something. Participants who completed the 10% Happier app averaged 31 (SD 33) min/week; patients completing the Calm app averaged 71 (SD 74) min/week. 10% Happier app participants saw small effects on anxiety (P<.001 d=?0.43), depression (P=.02; d=?0.38), sleep disturbance (P=.01; d=?0.40), total symptom burden (P=.13; d=?0.27), and fatigue (P=.06; d=?0.30), and moderate effects on physical health (P<.001; d=0.52). Calm app participants saw small effects on anxiety (P=.29; d=?0.22), depression (P=.09; d=?0.29), sleep disturbance (P=.002; d=?0.47), physical health (P=.005; d=0.44), total symptom burden (P=.13; d=?0.27), and fatigue (P=.13; d=?0.27). Educational control participants (n=61) did not have effects on any patient-reported outcome except for a moderate effect on physical health (P<.001; d=0.77). Conclusions: Delivering meditation via the Calm app is feasible and scored higher in terms of feasibility when compared with the 10% Happier app. The Calm app will be used to implement a randomized controlled trial, testing the effects of meditation on symptom burden in MPNs. Trial Registration: ClinicalTrials.gov NCT03726944; https://clinicaltrials.gov/ct2/show/NCT03726944 (Archived by WebCite at http://www.webcitation.org/77MVdFJwM) UR - http://formative.jmir.org/2019/2/e12662/ UR - http://dx.doi.org/10.2196/12662 UR - http://www.ncbi.nlm.nih.gov/pubmed/31033443 ID - info:doi/10.2196/12662 ER - TY - JOUR AU - Lyzwinski, Nathalie Lynnette AU - Caffery, Liam AU - Bambling, Matthew AU - Edirippulige, Sisira PY - 2019/04/10 TI - The Mindfulness App Trial for Weight, Weight-Related Behaviors, and Stress in University Students: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e12210 VL - 7 IS - 4 KW - mobile applications KW - mindfulness KW - body weight KW - feeding behavior KW - exercise KW - stress, psychological KW - students N2 - Background: University students are at risk of weight gain during their studies. Key factors related to weight gain in this population include unhealthy weight-related behaviors because of stress. Mindfulness holds promise for weight management. However, there has not been any previous trial that has explored the effectiveness of a student-tailored mindfulness app for stress, weight-related behaviors, and weight. There is limited evidence that current mindfulness apps use evidence-based mindfulness techniques. A novel app was developed that combined evidence-based, mindfulness-based stress reduction and mindful eating (ME) techniques that were tailored to university students, with student-relevant themes for targeting weight behaviors, weight, and stress. Objectives: The aim of this study was to test the effectiveness, acceptability, and feasibility of a student-tailored mindfulness app for weight, weight-related behaviors, and stress. Testing this app in a rigorous randomized controlled trial (RCT) for these outcomes is a novelty and contribution to this emerging field. Methods: A 2-arm RCT of an 11-week duration was undertaken at the University of Queensland. Students were either randomized to the mindfulness app (n=45) or to a behavioral self-monitoring electronic diary (e-diary; n=45) for diet and exercise. Analysis of covariance was used to compare differences in weight, stress, mindfulness, ME, physical activity, and eating behaviors between both groups. Results: Neither the mindfulness app group nor the e-diary group lost weight and there were no differences between the groups at follow-up. The mindfulness app group had significantly lower stress levels (P=.02) (adherers only), lower emotional eating (P=.02), and uncontrolled eating (P=.02) as well as higher mindfulness (P?.001) and ME levels overall (P?.001). The e-diary group had higher metabolic equivalents of moderate activity levels (P?.01). However, the effect sizes were small. Regular adherence to mindfulness exercises in the app was low in the group. The majority of students (94%) liked the app and found it to be acceptable. Compared with other exercises, the most helpful reported meditation was the short breathing exercise observing the breath (39.4% [13/33] preferred it). This was the first RCT that tested a mindfulness app for weight and weight-related behaviors in students. The modest level of user adherence likely contributes to the lack of effect on weight loss. However, there was a small, albeit promising, effect on weight-related eating behavior and stress. Conclusions: A mindfulness app demonstrated effectiveness for stress, eating behaviors, mindfulness, and ME, but the effect sizes were small. Future studies should be conducted over longer periods of time and with greater participant compliance. Trial Registration: Australian New Zealand Trial Registry ACTRN12616001349437; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371370 (Archived by WebCite at http://www.webcitation.org/761cc2K6ft) UR - https://mhealth.jmir.org/2019/4/e12210/ UR - http://dx.doi.org/10.2196/12210 UR - http://www.ncbi.nlm.nih.gov/pubmed/30969174 ID - info:doi/10.2196/12210 ER - TY - JOUR AU - Crandall, AliceAnn AU - Cheung, Aaron AU - Young, Ashley AU - Hooper, P. Audrey PY - 2019/03/22 TI - Theory-Based Predictors of Mindfulness Meditation Mobile App Usage: A Survey and Cohort Study JO - JMIR Mhealth Uhealth SP - e10794 VL - 7 IS - 3 KW - executive function KW - intention KW - mindfulness KW - mobile apps KW - social theory N2 - Background: Mindfulness meditation has become increasingly popular over the last few years, due in part to the increase in mobile apps incorporating the practice. Although studies have demonstrated the potential of mindfulness meditation to positively impact health, little has been uncovered about what predicts engagement in mindfulness meditation. Understanding the predictors of mindfulness meditation may help practitioners and phone app developers improve intervention strategies and app experience. Objective: The purpose of this study was to use the Theory of Planned Behavior and Temporal Self-Regulation Theory to determine factors predicting mindfulness meditation mobile app use. Methods: The sample consisted of 85 undergraduate students with no prior mindfulness meditation experience. During their first laboratory visit, participants completed tasks to measure their executive functioning and a survey to measure Theory of Planned Behavior constructs about mindfulness meditation. Over the following 2 weeks, participants logged the days and minutes that they practiced mindfulness meditation using a phone app. Hierarchical regression modeling was used to analyze the data. Results: After controlling for demographic factors, participant subjective norms (beta=14.51, P=.001) and intentions (beta=36.12, P=.001) were predictive of the number of minutes practicing mindfulness. Participant executive functioning did not predict mindfulness meditation practice, nor did it moderate the link between intentions and mindfulness meditation practice. Participant attitudes (beta=0.44, P<.001) and perceived control (beta=0.42, P=.002) were positively associated with intentions to practice mindfulness. Conclusions: These results suggest that among college student populations, the Theory of Planned Behavior may be useful in predicting the use of mindfulness meditation phone apps. However, participant executive functioning was not a predictor or moderator of mindfulness practice, and Temporal Self-Regulation Theory may be less useful for explaining mindfulness meditation behaviors using phone apps over a short period of time among college students. The results have implications for public health professionals, suggesting that a focus on subjective norms and intentions may promote mindfulness meditation practice using phone apps. UR - http://mhealth.jmir.org/2019/3/e10794/ UR - http://dx.doi.org/10.2196/10794 UR - http://www.ncbi.nlm.nih.gov/pubmed/30900992 ID - info:doi/10.2196/10794 ER - TY - JOUR AU - Sikder, Taher Abu AU - Yang, Cheng Francis AU - Schafer, Rhiana AU - Dowling, A. Glenna AU - Traeger, Lara AU - Jain, Ananda Felipe PY - 2019/03/21 TI - Mentalizing Imagery Therapy Mobile App to Enhance the Mood of Family Dementia Caregivers: Feasibility and Limited Efficacy Testing JO - JMIR Aging SP - e12850 VL - 2 IS - 1 KW - family caregivers KW - mindfulness KW - depression KW - mobile apps KW - psychotherapy N2 - Background: Family caregivers of patients with Alzheimer disease and related dementias (AD and ADRD) often experience high stress and are at high risk for depression. Technologically delivered therapy is attractive for AD and ADRD caregivers because of the time demands associated with in-person participation. Objective: We aimed to study the feasibility and conduct limited efficacy testing of a mobile app intervention delivering mentalizing imagery therapy (MIT) for family caregivers. Methods: A 4-week trial of the MIT app for family AD and ADRD caregivers was conducted to assess the feasibility of use and investigate changes in depression symptoms, mood, and caregiving experience. Semistructured interviews were conducted to characterize participants? perceived feasibility and benefits. Results: A total of 17 of the 21 (80%) consented participants (mean age 67 years, range 54-79) utilized the app at least once and were further analyzed. Average usage of audio recordings was on 14 (SD 10) days out of 28 possible and comprised 29 (SD 28) individual sessions. There were improvements in depression with a large effect size for those who used the app at least moderately (P=.008), increases in positive mood postintervention (P<.05), and acute increases in mood following daily guided imagery practice (Stretching and Breathing, P<.001; Eye in the Center, P<.001; Nesting Doll, P=.002; Situation Solver, P=.003; and Life Globe, P=.006). Semistructured interviews revealed perceived benefits such as greater ability to remain ?centered? despite caregiving challenges and positive reframing of the caregiver experience. Conclusions: App delivery of MIT is feasible for family AD and ADRD caregivers, including aging seniors. Results showed moderate to high usage of the app for a majority of users. Limited efficacy testing provides justification for studying the MIT app for AD and ADRD caregivers to improve mood and reduce depression in larger, controlled trials. UR - http://aging.jmir.org/2019/1/e12850/ UR - http://dx.doi.org/10.2196/12850 UR - http://www.ncbi.nlm.nih.gov/pubmed/31518275 ID - info:doi/10.2196/12850 ER - TY - JOUR AU - Donovan, Elizabeth AU - Martin, R. Sarah AU - Seidman, C. Laura AU - Zeltzer, K. Lonnie AU - Cousineau, M. Tara AU - Payne, A. Laura AU - Trant, Meredith AU - Weiman, Marjorie AU - Knoll, Marla AU - Federman, C. Noah PY - 2019/03/18 TI - A Mobile-Based Mindfulness and Social Support Program for Adolescents and Young Adults With Sarcoma: Development and Pilot Testing JO - JMIR Mhealth Uhealth SP - e10921 VL - 7 IS - 3 KW - cancer KW - mindfulness KW - social support KW - mobile app KW - adolescents KW - young adults N2 - Background: Approximately 70,000 adolescents and young adults (AYA) are diagnosed with cancer each year in the United States. Sarcomas carry a particularly high symptom burden and are some of the most common cancers among AYA. Recent work has documented significant levels of unmet needs among AYA with cancer, particularly the need for psychosocial support. Mobile technology may be a cost-effective and efficient way to deliver a psychosocial intervention to AYA with cancer and cancer survivors. Objective: The two aims of this study were to (1) develop a pilot version of a mobile-based mindfulness and social support program and (2) evaluate program usage and acceptability. An exploratory aim was to examine change in psychosocial outcomes. Methods: Thirty-seven AYA with sarcoma or sarcoma survivors, parents, and health care providers participated in the study. Semistructured interviews were conducted with 10 AYA, parents of five of the adolescents, and six health care providers. Themes from the interviews helped to inform the development of a mobile-based mindfulness pilot program and a companion Facebook-based social support group. Twenty AYA consented to participate in a single-arm pre-post evaluation of the program; 17 downloaded the app and joined the Facebook group. Seven of these participants had participated in the semistructured interviews. Six additional health care providers consented to participate in the evaluation stage. Results: On average, participants completed 16.9 of the 28 unique sessions and used the mindfulness app for a mean 10.2 (SD 8.2) days during the 28-day evaluation period. The majority of participants (16/17) engaged in the social group and posted at least one reply to the moderator?s prompts. The mean number of responses per person to the moderator of the social group was 15.2 of 31 (49%, range 0%-97%). Both AYA and health care providers responded positively to the Mindfulness for Resilience in Illness program and offered useful recommendations for improvements. Exploratory psychosocial analyses indicated there were no significant differences from pretest to posttest on measures of perceived social support, mindfulness, body image, or psychological functioning. Conclusions: This study offers preliminary support for the feasibility and acceptability of a mobile-based mindfulness and Facebook-based social support program for AYA with sarcoma. The feedback from AYA and health care providers will assist in creating a fully developed intervention. Trial Registration: ClinicalTrials.gov NCT03130751; https://clinicaltrials.gov/ct2/show/NCT03130751 UR - http://mhealth.jmir.org/2019/3/e10921/ UR - http://dx.doi.org/10.2196/10921 UR - http://www.ncbi.nlm.nih.gov/pubmed/30882352 ID - info:doi/10.2196/10921 ER - TY - JOUR AU - Joyce, Sadhbh AU - Shand, Fiona AU - Lal, J. Tara AU - Mott, Brendan AU - Bryant, A. Richard AU - Harvey, B. Samuel PY - 2019/02/19 TI - Resilience@Work Mindfulness Program: Results From a Cluster Randomized Controlled Trial With First Responders JO - J Med Internet Res SP - e12894 VL - 21 IS - 2 KW - resilience training KW - workplace mental health KW - occupational health KW - well-being KW - online intervention KW - employee resilience KW - health and safety KW - psychological health KW - first responders N2 - Background: A growing body of research suggests that resilience training can play a pivotal role in creating mentally healthy workplaces, particularly with regard to protecting the long-term well-being of workers. Emerging research describes positive outcomes from various types of resilience training programs (RTPs) among different occupational groups. One specific group of workers that may benefit from this form of proactive resilience training is first responders. Given the nature of their work, first responders are frequently exposed to stressful circumstances and potentially traumatic events, which may impact their overall resilience and well-being over time. Objective: This study aimed to examine whether a mindfulness-based RTP (the Resilience@Work [RAW] Mindfulness Program) delivered via the internet can effectively enhance resilience among a group of high-risk workers. Methods: We conducted a cluster randomized controlled trial (RCT) comprising 24 Primary Fire and Rescue and Hazmat stations within New South Wales. Overall, 12 stations were assigned to the 6-session RAW Mindfulness Program and 12 stations were assigned to the control condition. A total of 143 active full-time firefighters enrolled in the study. Questionnaires were administered at baseline, immediately post training, and at 6-month follow-up. Measurements examined change in both adaptive and bounce-back resilience as well as several secondary outcomes examining resilience resources and acceptance and mindfulness skills. Results: Mixed-model repeated measures analysis found that the overall test of group-by-time interaction was significant (P=.008), with the intervention group increasing in adaptive resilience over time. However, no significant differences were found between the intervention group and the control group in terms of change in bounce-back resilience (P=.09). At 6-month follow-up, the group receiving the RAW intervention had an average increase in their resilience score of 1.3, equating to a moderate-to-large effect size compared with the control group of 0.73 (95% CI 0.38-1.06). Per-protocol analysis found that compared with the control group, the greatest improvements in adaptive resilience were observed among those who completed most of the RAW program, that is, 5 to 6 sessions (P=.002). Conclusions: The results of this RCT suggest that mindfulness-based resilience training delivered in an internet format can create improvements in adaptive resilience and related resources among high-risk workers, such as first responders. Despite a number of limitations, the results of this study suggest that the RAW Mindfulness Program is an effective, scalable, and practical means of delivering online resilience training in high-risk workplace settings. To the best of our knowledge, this is the first time a mindfulness-based RTP delivered entirely via the internet has been tested in the workplace. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000574549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368296 (Archived by WebCite at http://www.webcitation.org/75w4xtrpw). UR - http://www.jmir.org/2019/2/e12894/ UR - http://dx.doi.org/10.2196/12894 UR - http://www.ncbi.nlm.nih.gov/pubmed/30777846 ID - info:doi/10.2196/12894 ER - TY - JOUR AU - Goldin, R. Philippe AU - Lindholm, Riku AU - Ranta, Kristian AU - Hilgert, Outi AU - Helteenvuori, Tiia AU - Raevuori, Anu PY - 2019/01/22 TI - Feasibility of a Therapist-Supported, Mobile Phone?Delivered Online Intervention for Depression: Longitudinal Observational Study JO - JMIR Formativ Res SP - e11509 VL - 3 IS - 1 KW - cognitive therapy KW - depression KW - digital health KW - digital therapeutics KW - mindfulness KW - online intervention N2 - Background: Depression is a very common condition that impairs functioning and is often untreated. More than 60% of the treatments for depressive disorder are administered in primary care settings by care providers who lack the time and expertise to treat depression. To address this issue, we developed Ascend, a therapist-supported, mobile phone?delivered 8-week intervention administered at the Meru Health Online Clinic in Finland. Objective: We conducted two pilot studies to examine the feasibility of the Ascend intervention, specifically, dropout rates, daily practice, weekly group chat use, and changes in depression symptoms. We also explored whether daily practice and weekly group chat use were associated with changes in depression symptoms. Methods: A total of 117 Finnish adults with elevated depressive symptoms enrolled in Ascend, a program that included daily cognitive behavioral and mindfulness meditation exercises delivered through a mobile phone app, anonymous group chat with other users, and chat/phone access to a licensed therapist. Eight weekly themes were delivered in a fixed, sequential format. Depression symptoms were measured at baseline, every second week during the intervention, immediately after the intervention, and 4 weeks after completion of the intervention. Data were analyzed using intent-to-treat repeated-measures analysis of variance and linear regression models. Results: For studies 1 and 2, we observed dropout rates of 27% and 15%, respectively, decreasing daily practice and group chat use, and decreased depression symptoms from baseline to immediately and 4 weeks after the intervention (P<.001). We found that both more daily practice and chat group use predicted the occurrence of fewer depressive symptoms at 4 weeks postintervention (Study 1: ?R2=.38, P=.004 and ?R2=.38, P=.002, respectively; Study 2: ?R2=.16, P<.001 and ?R2=.08, P=.002, respectively). Conclusions: This therapist-supported, mobile phone?delivered treatment for depression is feasible and associated with reduced depression symptoms. Design features that enhance daily practice and group chat use are areas of future investigation. Validation of these results using a controlled study design is needed to establish the evidence base for the Ascend intervention. UR - http://formative.jmir.org/2019/1/e11509/ UR - http://dx.doi.org/10.2196/11509 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/11509 ER - TY - JOUR AU - Plans, David AU - Morelli, Davide AU - Sütterlin, Stefan AU - Ollis, Lucie AU - Derbyshire, Georgia AU - Cropley, Mark PY - 2019/01/11 TI - Use of a Biofeedback Breathing App to Augment Poststress Physiological Recovery: Randomized Pilot Study JO - JMIR Formativ Res SP - e12227 VL - 3 IS - 1 KW - biofeedback KW - breathing KW - heart rate variability KW - recovery KW - rumination KW - stress N2 - Background: The speed of physiological recovery from stress may be a marker for cardiovascular disease risk. Stress management programs that incorporate guided breathing have been shown to moderate the stress response and augment recovery. Objective: The aim of this study was to examine the effectiveness of an app-based brief relaxation intervention (BioBase) for facilitating physiological recovery in individuals exposed to a brief psychological stressor. Methods: A total of 75 participants (44 women) completed a stressor speech task and were randomly assigned to one of three conditions: control, rumination, or an app-based relaxation breathing (BioBase) conditions. Heart rate variability (HRV) was assessed as a measure of autonomic function at baseline (6 min), during stress (6 min), and during recovery (6 min). Results: There was a significant increase in subjective stress following stress exposure, but the ratings returned to baseline after recovery in all three groups. In addition, there was a significant decrease in vagally mediated HRV in the poststress period. During recovery, the root mean square of successive differences (P<.001), the percentage of successive interbeat (RR) intervals that differ by >50?ms (pNN50; P<.001), and high-frequency (P<.02) HRV were significantly higher in the BioBase breathing condition than the rumination and control conditions. There was no difference in HRV values between the rumination and control conditions during recovery. Conclusions: App-based relaxed breathing interventions could be effective in reducing cardiovascular disease risk. These results provide additional utility of biofeedback breathing in augmenting physiological recovery from psychological stress. UR - https://formative.jmir.org/2019/1/e12227/ UR - http://dx.doi.org/10.2196/12227 UR - http://www.ncbi.nlm.nih.gov/pubmed/30684437 ID - info:doi/10.2196/12227 ER - TY - JOUR AU - Walsh, Marie Kathleen AU - Saab, J. Bechara AU - Farb, AS Norman PY - 2019/01/08 TI - Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study JO - JMIR Ment Health SP - e10844 VL - 6 IS - 1 KW - mindfulness KW - attention KW - mobile health KW - interoception KW - mood KW - stress, psychological N2 - Background: Mindfulness training (MT) includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of nonjudgment and curiosity. Following the success of 8-week, manualized group interventions, MT has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested. Objective: This study aimed to investigate a newly developed MT app called Wildflowers, which was codeveloped with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of MT through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature. Methods: Undergraduate students completed 3 weeks of MT with Wildflowers (n=45) or 3 weeks of cognitive training with a game called 2048 (n=41). State training effects were assessed through pre- and postsession ratings of current mood, stress level, and heart rate. Trait training effects were assessed through pre- and postintervention questionnaires canvassing subjective well-being and behavioral task measures of attentional control and interoceptive integration. State and trait training data were analyzed in a multilevel model using emergent latent factors (acceptance, awareness, and openness) to summarize the trait questionnaire battery. Results: Analyses revealed both state and trait effects specific to MT; participants engaging in MT demonstrated improved mood (r=.14) and a reduction of stress (r=?.13) immediately after each training session compared with before the training session and decreased postsession stress over 3 weeks (r=?.08). In addition, MT relative to cognitive training resulted in greater improvements in attentional control (r=?.24). Interestingly, both groups demonstrated increased subjective ratings of awareness (r=.28) and acceptance (r=.23) from pre- to postintervention, with greater changes in acceptance for the MT group trending (r=.21). Conclusions: MT, using a smartphone app, may provide immediate effects on mood and stress while also providing long-term benefits for attentional control. Although further investigation is warranted, there is evidence that with continued usage, MT via a smartphone app may provide long-term benefits in changing how one relates to their inner and outer experiences. Trial Registration: ClinicalTrials.gov NCT03783793; https://clinicaltrials.gov/ct2/show/NCT03783793 (Archived by WebCite at http://www.webcitation.org/75EF2ehst) UR - https://mental.jmir.org/2019/1/e10844/ UR - http://dx.doi.org/10.2196/10844 UR - http://www.ncbi.nlm.nih.gov/pubmed/30622094 ID - info:doi/10.2196/10844 ER - TY - JOUR AU - Spears, A. Claire AU - Bell, A. Sharrill AU - Scarlett, A. Charlayne AU - Anderson, K. Natalie AU - Cottrell-Daniels, Cherell AU - Lotfalian, Sadaf AU - Bandlamudi, Maitreyi AU - Grant, Amanda AU - Sigurdardottir, Anna AU - Carter, P. Brittani AU - Abroms, C. Lorien AU - Wetter, W. David PY - 2019/01/07 TI - Text Messaging to Enhance Mindfulness-Based Smoking Cessation Treatment: Program Development Through Qualitative Research JO - JMIR Mhealth Uhealth SP - e11246 VL - 7 IS - 1 KW - mobile phone KW - low socioeconomic status KW - qualitative KW - short message service text messaging KW - smoking cessation N2 - Background: Mindfulness-based programs show promise for promoting smoking cessation in diverse populations. Mobile health strategies could increase treatment engagement and in-the-moment support, thus enhancing the effects of mindfulness-based smoking cessation interventions. However, most mobile health programs have been developed without sufficient input from the target population. Objective: By eliciting input from the target population, predominantly low socioeconomic status (SES) African American adult smokers, throughout the development of an SMS (short message service) text messaging program that teaches mindfulness for smoking cessation, we aimed for the resulting program to be optimally effective and consistent with participants? needs and preferences. Methods: Two qualitative studies (N=25) were conducted with predominantly low SES, African American adult smokers. In Study 1 (initial qualitative input; n=15), participants engaged in focus groups to provide suggestions for program development. In Study 2 (abbreviated trial; n=10), participants received a 1-week version of the SMS text messaging program and provided feedback through in-depth interviews. Results: In Study 1, participants suggested that the SMS text messaging program should be personalized and interactive (ie, involve two-way messaging); provide strategies for coping with cravings and recovering from smoking lapses; involve relatively short, to-the-point messages; and include pictures. In Study 2, participants were highly engaged with the texts, indicated that the program was useful, and provided additional suggestions for improvement. Conclusions: Eliciting feedback from the target population throughout the intervention development process allowed for iterative revisions to increase feasibility, acceptability, and effectiveness. Overall, SMS text messaging appears to be a feasible, appealing way to provide in-the-moment personalized support and encourage mindfulness among low-income African American smokers. UR - https://mhealth.jmir.org/2019/1/e11246/ UR - http://dx.doi.org/10.2196/11246 UR - http://www.ncbi.nlm.nih.gov/pubmed/30617043 ID - info:doi/10.2196/11246 ER - TY - JOUR AU - Mikolasek, Michael AU - Witt, M. Claudia AU - Barth, Jürgen PY - 2018/12/06 TI - Adherence to a Mindfulness and Relaxation Self-Care App for Cancer Patients: Mixed-Methods Feasibility Study JO - JMIR Mhealth Uhealth SP - e11271 VL - 6 IS - 12 KW - mobile app KW - mindfulness KW - relaxation KW - cancer KW - patient compliance N2 - Background: Cancer is highly prevalent worldwide and can cause high levels of distress in patients, which is often neglected in medical care. Smartphone apps are readily available and therefore seem promising to deliver distress-reducing interventions such as mindfulness and relaxation programs. Objective: This study aimed to evaluate the feasibility of a mindfulness and relaxation app for cancer patients. We looked at characteristics of participating patients in a mobile health (mHealth) study, including adherence to the app intervention, predictors for adherence, and patients? feedback regarding the app. Methods: In this prospective observational study with a mixed-methods approach, cancer patients received a mindfulness and relaxation self-care app. Cancer patients were recruited online and through hospitals in Switzerland. We assessed self-reported measures (eg, quality of life, anxiety, depressive symptoms, openness to experience, resistance to change) at baseline, and the app gathered data on patients? practicing time. With 8 semistructured interviews, we obtained patients? feedback about the app and recommendations for improvements. We looked at 3 dimensions of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework (reach, adoption, and maintenance) and analyzed data for adherence for the first 10 weeks of the app intervention. We report descriptive statistics for patient characteristics and app use. For the prediction of adherence, we used Kaplan-Meier analyses with log-rank tests and a Cox proportional hazards regression. Results: Data from 100 cancer patients (74 female) showed that 54 patients were using the app exercises continuously until week 10. In continuous app users, the median number of exercises per week dropped from 4 (interquartile range, IQR 1-7) at week 1 to a median of 2 (IQR 1-4) at week 10. Our analyses revealed 4 significant predictors for better adherence: female gender, higher openness to experience, higher resistance to change, and more depressive symptoms. Interviews revealed that the patients generally were satisfied with the app but also made suggestions on how to improve it. Conclusions: Our study indicates that a mindfulness and relaxation mHealth intervention for cancer patients is feasible with acceptable adherence and largely positive feedback from patients. Trial Registration: German Clinical Trials Register DRKS00010481; https://www.drks.de/drks_web/navigate.do?navigation Id=trial.HTML&TRIAL_ID=DRKS00010481 (Archived by WebCite at http://www.webcitation.org/73xGE1B0P) UR - https://mhealth.jmir.org/2018/12/e11271/ UR - http://dx.doi.org/10.2196/11271 UR - http://www.ncbi.nlm.nih.gov/pubmed/30522990 ID - info:doi/10.2196/11271 ER - TY - JOUR AU - Mak, WS Winnie AU - Tong, CY Alan AU - Yip, YC Sindy AU - Lui, WS Wacy AU - Chio, HN Floria AU - Chan, TY Amy AU - Wong, CY Celia PY - 2018/10/11 TI - Efficacy and Moderation of Mobile App?Based Programs for Mindfulness-Based Training, Self-Compassion Training, and Cognitive Behavioral Psychoeducation on Mental Health: Randomized Controlled Noninferiority Trial JO - JMIR Ment Health SP - e60 VL - 5 IS - 4 KW - mental health KW - mobile apps KW - mindfulness KW - compassion N2 - Background: Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, this study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile apps in the improvement of mental health. Objective: The aim of this study was to examine the efficacy of 3 mobile app?based programs: mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation program in improving mental well-being and reducing psychological distress. Changes in mindful awareness and self-compassion were also assessed. To further delineate the suitability of each program for different types of individuals, individual difference variables (ie, discomfort with emotions and tolerance for ambiguity) were explored for potential moderation. Methods: This study was a 3-arm, randomized, controlled, noninferiority trial examining the efficacy of mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation. Participants were randomized into either 1 of the 3 conditions. Throughout the 4-week, 28-session program, participants spent 10-15 min daily reviewing the course content and practicing various related exercises. At preprogram, postprogram, and 3-month follow-up, participants also completed Web-based measures of mental well-being, psychological distress, mindful-awareness, and self-compassion as well as the proposed moderators. Results: Among the 2161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment, respectively. All 3 conditions (mindfulness-based program: N=703; cognitive behavioral psychoeducation: N=753; self-compassion program: N=705) were found to be efficacious in improving mental well-being and reducing psychological distress. All conditions enhanced mindful awareness at postprogram. Significant interaction effect was found on self-compassion; cognitive behavioral psychoeducation and self-compassion program, but not mindfulness-based program, significantly enhanced self-compassion at postprogram. No significant differences regarding usage and users? satisfaction were found among the 3 conditions. None of the proposed moderators were found to be significant. Conclusions: Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile apps were efficacious in improving mental well-being and reducing psychological distress among adults at postprogram and 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rates that are common in app-based health promotion programs. Trial Registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; http://www.chictr.org.cn/hvshowproject.aspx?id=6220 (Archived by WebCite at http://www.webcitation.org/734PlOz50) UR - http://mental.jmir.org/2018/4/e60/ UR - http://dx.doi.org/10.2196/mental.8597 UR - http://www.ncbi.nlm.nih.gov/pubmed/30309837 ID - info:doi/10.2196/mental.8597 ER - TY - JOUR AU - Sevilla-Llewellyn-Jones, Julia AU - Santesteban-Echarri, Olga AU - Pryor, Ingrid AU - McGorry, Patrick AU - Alvarez-Jimenez, Mario PY - 2018/9/25 TI - Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis JO - JMIR Ment Health SP - e10278 VL - 5 IS - 3 KW - mindfulness KW - anxiety disorder KW - depressive disorder KW - internetinternet-based KW - treatment KW - meta-analysis KW - mental health. KW - systematic review N2 - Background: Web-based mindfulness interventions are increasingly delivered through the internet to treat mental health conditions. Objective: The objective of this study was to determine the effectiveness of web-based mindfulness interventions in clinical mental health populations. Secondary aims were to explore the impact of study variables on the effectiveness of web-based mindfulness interventions. Methods: We performed a systematic review and meta-analysis of studies investigating the effects of web-based mindfulness interventions on clinical populations. Results: The search strategy yielded 12 eligible studies. Web-based mindfulness interventions were effective in reducing depression in the total clinical sample (n=656 g=?0.609, P=.004) and in the anxiety disorder subgroup (n=313, g=?0.651, P<.001), but not in the depression disorder subgroup (n=251, P=.18). Similarly, web-based mindfulness interventions significantly reduced anxiety in the total clinical sample (n=756, g=?0.433, P=.004) and the anxiety disorder subgroup (n=413, g=?0.719, P<.001), but not in the depression disorder group (n=251, g=?0.213, P=.28). Finally, web-based mindfulness interventions improved quality of life and functioning in the total sample (n=591, g=0.362, P=.02) in the anxiety disorder subgroup (n=370, g=0.550, P=.02) and mindfulness skills in the total clinical sample (n=251, g=0.724, P<.001). Conclusions: Results support the effectiveness of web-based mindfulness interventions in reducing depression and anxiety and in enhancing quality of life and mindfulness skills, particularly in those with clinical anxiety. Results should be interpreted with caution given the high heterogeneity of web-based mindfulness interventions and the low number of studies included. UR - http://mental.jmir.org/2018/3/e10278/ UR - http://dx.doi.org/10.2196/10278 UR - http://www.ncbi.nlm.nih.gov/pubmed/30274963 ID - info:doi/10.2196/10278 ER - TY - JOUR AU - Joyce, Sadhbh AU - Shand, Fiona AU - Bryant, A. Richard AU - Lal, J. Tara AU - Harvey, B. Samuel PY - 2018/09/11 TI - Mindfulness-Based Resilience Training in the Workplace: Pilot Study of the Internet-Based Resilience@Work (RAW) Mindfulness Program JO - J Med Internet Res SP - e10326 VL - 20 IS - 9 KW - resilience training KW - workplace mental health KW - occupational health KW - wellbeing KW - online intervention KW - employee resilience KW - health and safety KW - psychological health N2 - Background: The impact of mental illness on society is far reaching and has been identified as the leading cause of sickness absence and work disability in most developed countries. By developing evidence-based solutions that are practical, affordable, and accessible, there is potential to deliver substantial economic benefits while improving the lives of individual workers. Academic and industry groups are now responding to this public health issue. A key focus is on developing practical solutions that enhance the mental health and psychological resilience of workers. A growing body of research suggests resilience training may play a pivotal role in the realm of public health and prevention, particularly with regards to protecting the long-term well-being of workers. Objective: Our aim is to examine whether a mindfulness-based resilience-training program delivered via the internet is feasible and engaging to a group of high-risk workers. Additionally, we aim to measure the effect of the Resilience@Work Resilience@Work Mindfulness program on measures of resilience and related skills. Methods: The current pilot study recruited 29 full-time firefighters. Participants were enrolled in the 6-session internet-based resilience-training program and were administered questionnaires prior to training and directly after the program ended. Measurements examined program feasibility, psychological resilience, experiential avoidance, and thought entanglement. Results: Participants reported greater levels of resilience after Resilience@Work training compared to baseline, with a mean increase in their overall resilience score of 1.5 (95% CI -0.25 to 3.18, t14=1.84, P=.09). Compared to baseline, participants also reported lower levels of psychological inflexibility and experiential avoidance following training, with a mean decrease of -1.8 (95% CI -3.78 to 0.20, t13=-1.94, P=.07). With regards to cognitive fusion (thought entanglement), paired-samples t tests revealed a trend towards reduction in mean scores post training (P=.12). Conclusions: This pilot study of the Resilience@Work program suggests that a mindfulness-based resilience program delivered via the Internet is feasible in a high-risk workplace setting. In addition, the firefighters using the program showed a trend toward increased resilience and psychological flexibility. Despite a number of limitations, the results of this pilot study provide some valuable insights into what form of resilience training may be viable in occupational settings particularly among those considered high risk, such as emergency workers. To the best of our knowledge, this is the first time a mindfulness-based resilience-training program delivered wholly via the internet has been tested in the workplace. UR - http://www.jmir.org/2018/9/e10326/ UR - http://dx.doi.org/10.2196/10326 UR - http://www.ncbi.nlm.nih.gov/pubmed/30206055 ID - info:doi/10.2196/10326 ER - TY - JOUR AU - Børøsund, Elin AU - Mirkovic, Jelena AU - Clark, M. Matthew AU - Ehlers, L. Shawna AU - Andrykowski, A. Michael AU - Bergland, Anne AU - Westeng, Marianne AU - Solberg Nes, Lise PY - 2018/09/06 TI - A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing JO - JMIR Formativ Res SP - e19 VL - 2 IS - 2 KW - stress management KW - mindfulness KW - cancer KW - eHealth KW - mHealth KW - mobile apps KW - development KW - usability KW - user-centered design KW - mobile phones N2 - Background: Distress is prevalent in cancer survivors. Stress management interventions can reduce distress and improve quality of life for cancer patients, but many people with cancer are unfortunately not offered or able to attend such in-person stress management interventions. Objective: The objective of this study was to develop an evidence-based stress management intervention for patients living with cancer that can be delivered electronically with wide reach and dissemination. This paper describes the design and development process of a technology-based stress management intervention for cancer survivors, including the exploration phase, intervention content development, iterative software development (including design, development, and formative evaluation of low- and high-level prototypes), and security and privacy considerations. Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=48). In the exploration phase, identifying needs and requirements for the intervention, 28 participants gave input, including male and female cancer survivors (n=11) representing a wide age range (31-81 years) and cancer diagnoses, healthcare providers (n=8) including psychosocial oncology experts, and eHealth experts (n=9) including information technology design and developers. To ensure user involvement in each phase various user-centered design and service design methods were included, such as interviews, usability testing, and think aloud processes. Overall, participants were involved usability testing in the software development and formative evaluation phase, including cancer survivors (n=6), healthy volunteers (n=7), health care providers (n=2), and eHealth experts (n=5). Intervention content was developed by stress management experts based on well-known cognitive behavioral stress management strategies and adjusted to electronic format through multiple iterations with stakeholders. Privacy and security issues were considered throughout. Results: The design and development process identified a variety of stakeholder requirements. Cancer survivors preferred stress management through a mobile app rather than through a personal computer (PC) and identified usefulness, easy access, user friendliness, use of easily understandable language, and many brief sections rather than longer ones as important components of the intervention. These requirements were also supported by recommendations from health care providers and eHealth experts. The final intervention was named StressProffen and the hospital Privacy and Security Protection Committee was part of the final intervention approval to also ensure anchoring in the hospital organization. Conclusions: Interventions, even evidence-based, have little impact if not actively used. This study illustrates how user-centered design and service design can be applied to identify and incorporate essential stakeholder aspects in the entire design and development process. In combination with evidence-based concepts, this process facilitated development of a stress management intervention truly designed for the end users, in this case, cancer survivors. Trial Registration: ClinicalTrials.gov NCT02939612; https://clinicaltrials.gov/ct2/show/NCT02939612 (Archived at WebCite at http://www.webcitation.org/71l9HcfcB) UR - http://formative.jmir.org/2018/2/e19/ UR - http://dx.doi.org/10.2196/formative.9954 UR - http://www.ncbi.nlm.nih.gov/pubmed/30684438 ID - info:doi/10.2196/formative.9954 ER - TY - JOUR AU - Russell, Lahiru AU - Ugalde, Anna AU - Milne, Donna AU - Austin, David AU - Livingston, M. Patricia PY - 2018/08/21 TI - Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review JO - JMIR Ment Health SP - e53 VL - 5 IS - 3 KW - mindfulness KW - internet KW - chronic condition N2 - Background: Internet-supported mindfulness-based interventions (MBIs) are increasingly being used to support people with a chronic condition. Characteristics of MBIs vary greatly in their mode of delivery, communication patterns, level of facilitator involvement, intervention period, and resource intensity, making it difficult to compare how individual digital features may optimize intervention adherence and outcomes. Objective: The aims of this review were to (1) provide a description of digital characteristics of internet-supported MBIs and examine how these relate to evidence for efficacy and adherence to the intervention and (2) gain insights into the type of information available to inform translation of internet-supported MBIs to applied settings. Methods: MEDLINE Complete, PsycINFO, and CINAHL databases were searched for studies assessing an MBI delivered or accessed via the internet and engaging participants in daily mindfulness-based activities such as mindfulness meditations and informal mindfulness practices. Only studies using a comparison group of alternative interventions (active compactor), usual care, or wait-list were included. Given the broad definition of chronic conditions, specific conditions were not included in the original search to maximize results. The search resulted in 958 articles, from which 11 articles describing 10 interventions met the inclusion criteria. Results: Internet-supported MBIs were more effective than usual care or wait-list groups, and self-guided interventions were as effective as facilitator-guided interventions. Findings were informed mainly by female participants. Adherence to interventions was inconsistently defined and prevented robust comparison between studies. Reporting of factors associated with intervention dissemination, such as population representativeness, program adoption and maintenance, and costs, was rare. Conclusions: More comprehensive descriptions of digital characteristics need to be reported to further our understanding of features that may influence engagement and behavior change and to improve the reproducibility of MBIs. Gender differences in determinants and patterns of health behavior should be taken into account at the intervention design stage to accommodate male and female preferences. Future research could compare MBIs with established evidence-based therapies to identify the population groups that would benefit most from internet-supported programs. Trial Registration: PROSPERO CRD42017078665; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=78665 (Archived by WebCite at http://www.webcitation.org/71ountJpu) UR - http://mental.jmir.org/2018/3/e53/ UR - http://dx.doi.org/10.2196/mental.9645 UR - http://www.ncbi.nlm.nih.gov/pubmed/30131317 ID - info:doi/10.2196/mental.9645 ER - TY - JOUR AU - Choo, C. Carol AU - Burton, AD André PY - 2018/06/07 TI - Smartphone Apps for Mindfulness Interventions for Suicidality in Asian Youths: Literature Review JO - JMIR Mhealth Uhealth SP - e139 VL - 6 IS - 6 KW - suicidality KW - Asian youths KW - smartphone applications KW - mindfulness N2 - Background: The advent of mobile technology has ushered in an era in which smartphone apps can be used as interventions for suicidality. Objective: We aimed to review recent research that is relevant to smartphone apps that can be used for mindfulness interventions for suicidality in Asian youths. Methods: The inclusion criteria for this review were: papers published in peer-reviewed journals from 2007 to 2017 with usage of search terms (namely ?smartphone application? and ?mindfulness?) and screened by an experienced Asian clinician to be of clinical utility for mindfulness interventions for suicidality with Asian youths. Results: The initial search of databases yielded 375 results. Fourteen full text papers that fit the inclusion criteria were assessed for eligibility and 10 papers were included in the current review. Conclusions: This review highlighted the paucity of evidence-based and empirically validated research into effective smartphone apps that can be used for mindfulness interventions for suicidality with Asian youths. UR - http://mhealth.jmir.org/2018/6/e139/ UR - http://dx.doi.org/10.2196/mhealth.8304 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/mhealth.8304 ER - TY - JOUR AU - Owens, L. Otis AU - Beer, M. Jenay AU - Reyes, I. Ligia AU - Gallerani, G. David AU - Myhren-Bennett, R. Amanda AU - McDonnell, K. Karen PY - 2018/05/15 TI - Mindfulness-Based Symptom and Stress Management Apps for Adults With Chronic Lung Disease: Systematic Search in App Stores JO - JMIR Mhealth Uhealth SP - e124 VL - 6 IS - 5 KW - mindfulness KW - lung neoplasms KW - chronic obstructive pulmonary disease KW - mobile apps KW - review N2 - Background: Up to 70% of lung cancer survivors are affected by chronic obstructive pulmonary disease (COPD), a common, debilitating, comorbid disease. Lung cancer and COPD are both characterized by symptoms such as breathlessness, fatigue, and psychological distress. These distressing chronic symptoms are exacerbated by stress and detract from an individual?s quality of life. Objective: The aim of this study was to identify and evaluate evidence-based, commercially available apps for promoting mindfulness-based strategies among adults with a COPD or lung cancer history (ie, chronic lung disease). Methods: For this review, an interdisciplinary research team used 19 keyword combinations in the search engines of Google and iOS app stores in May 2017. Evaluations were conducted on the apps? (1) content, (2) usability heuristics, (3) grade-level readability, and (4) cultural sensitivity. Results: The search resulted in 768 apps (508 in iOS and 260 in Google stores). A total of 9 apps met the inclusion criteria and received further evaluation. Only 1 app had below an eighth-grade reading level; the ninth one did not have enough text to calculate a readability score. None of the 9 apps met the cultural sensitivity evaluation criteria. Conclusions: This systematic review identified critical design flaws that may affect the ease of using the apps in this study. Few mobile apps promote mindfulness-based strategies among adults with chronic lung disease (ie, COPD or lung cancer or both), but those that exist, overall, do not meet the latest scientific evidence. Recommendations include more stringent regulation of health-related apps, use of evidence-based frameworks and participatory design processes, following evidence-based usability practices, use of culturally sensitive language and images, and ensuring that content is written in plain language. UR - http://mhealth.jmir.org/2018/5/e124/ UR - http://dx.doi.org/10.2196/mhealth.9831 UR - http://www.ncbi.nlm.nih.gov/pubmed/29764800 ID - info:doi/10.2196/mhealth.9831 ER - TY - JOUR AU - Ball, Elizabeth AU - Newton, Sian AU - Kahan, C. Brennan AU - Forbes, Gordon AU - Wright, Neil AU - Cantalapiedra Calvete, Clara AU - Gibson, L. Harry A. AU - Rogozinska, Ewelina AU - Rivas, Carol AU - Taylor, C. Stephanie J. AU - Birch, Judy AU - Dodds, Julie PY - 2018/01/15 TI - Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial JO - JMIR Res Protoc SP - e8 VL - 7 IS - 1 KW - randomized controlled trial KW - pelvic pain KW - chronic pain KW - mobile applications KW - mindfulness KW - meditation N2 - Background: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. Objective: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. Methods: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. Results: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. Conclusions: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. Trial Registration: ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys) UR - http://www.researchprotocols.org/2018/1/e8/ UR - http://dx.doi.org/10.2196/resprot.7720 UR - http://www.ncbi.nlm.nih.gov/pubmed/29335232 ID - info:doi/10.2196/resprot.7720 ER - TY - JOUR AU - Compen, R. Félix AU - Bisseling, M. Else AU - Schellekens, PJ Melanie AU - Jansen, TM Ellen AU - van der Lee, L. Marije AU - Speckens, EM Anne PY - 2017/12/18 TI - Mindfulness-Based Cognitive Therapy for Cancer Patients Delivered via Internet: Qualitative Study of Patient and Therapist Barriers and Facilitators JO - J Med Internet Res SP - e407 VL - 19 IS - 12 KW - mindfulness KW - psycho-oncology KW - cancer survivors KW - telemedicine KW - qualitative research N2 - Background: The number of patients living with cancer is growing, and a substantial number of patients suffer from psychological distress. Mindfulness-based interventions (MBIs) seem effective in alleviating psychological distress. Unfortunately, several cancer patients find it difficult, if not impossible, to attend a group-based course. Internet-based MBIs (eMBIs) such as Internet-based mindfulness-based cognitive therapy (eMBCT) may offer solutions. However, it is yet to be studied what facilitators and barriers cancer patients experience during eMBCT. Objective: This study aimed to explore facilitators and barriers of individual asynchronous therapist-assisted eMBCT as experienced by both patients and therapists. Methods: Patients with heterogeneous cancer diagnoses suffering from psychological distress were offered eMBCT. This 9-week intervention mirrored the group-based MBCT protocol and included weekly asynchronous written therapist feedback. Patients were granted access to a website that contained the eMBCT protocol and a secured inbox, and they were asked to practice and fill out diaries on which the therapist provided feedback. In total, 31 patients participated in an individual posttreatment interview on experienced facilitators and barriers during eMBCT. Moreover, eight therapists were interviewed. The data were analyzed with qualitative content analysis to identify barriers and facilitators in eMBCT. Results: Both patients and therapists mentioned four overarching themes as facilitators and barriers: treatment setting (the individual and Internet-based nature of the treatment), treatment format (how the treatment and its guidance were organized and delivered), role of the therapist, and individual patient characteristics. Conclusions: The eMBCT provided flexibility in when, where, and how patients and therapists engage in MBCT. Future studies should assess how different eMBCT designs could further improve barriers that were found. UR - http://www.jmir.org/2017/12/e407/ UR - http://dx.doi.org/10.2196/jmir.7783 UR - http://www.ncbi.nlm.nih.gov/pubmed/29254912 ID - info:doi/10.2196/jmir.7783 ER - TY - JOUR AU - Chadi, Nicholas AU - Kaufman, Miriam AU - Weisbaum, Elli AU - Malboeuf-Hurtubise, Catherine AU - Kohut, Ahola Sara AU - Viner, Christine AU - Locke, Jake AU - Vo, X. Dzung PY - 2017/11/27 TI - In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e241 VL - 6 IS - 11 KW - mindfulness KW - meditation KW - chronic illness KW - adolescent KW - eHealth KW - randomized KW - protocol N2 - Background: Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities. Objective: This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth. Methods: This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. Results: Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018. Conclusions: Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. Trial Registration: ClinicalTrials.org NCT03067207; https://clinicaltrials.gov/ct2/show/NCT03067207 (archived by WebCite at http://www.webcitation.org/6v4ZK8RBH) UR - http://www.researchprotocols.org/2017/11/e241/ UR - http://dx.doi.org/10.2196/resprot.7700 UR - http://www.ncbi.nlm.nih.gov/pubmed/29180345 ID - info:doi/10.2196/resprot.7700 ER - TY - JOUR AU - Toivonen, I. Kirsti AU - Zernicke, Kristin AU - Carlson, E. Linda PY - 2017/08/31 TI - Web-Based Mindfulness Interventions for People With Physical Health Conditions: Systematic Review JO - J Med Internet Res SP - e303 VL - 19 IS - 8 KW - Internet KW - mindfulness KW - review N2 - Background: Mindfulness-based interventions (MBIs) are becoming increasingly popular for helping people with physical health conditions. Expanding from traditional face-to-face program delivery, there is growing interest in Web-based application of MBIs, though Web-based MBIs for people with physical health conditions specifically have not been thoroughly reviewed to date. Objective: The objective of this paper was to review Web-based MBIs for people with physical health conditions and to examine all outcomes reported (eg, efficacy or effectiveness for physical changes or psychological changes; feasibility). Methods: Databases PubMed, PsycINFO, Science Direct, CINAHL Plus, and Web of Science were searched. Full-text English papers that described any Web-based MBI, examining any outcome, for people with chronic physical health conditions were included. Randomized, nonrandomized, controlled, and uncontrolled trials were all included. Extracted data included intervention characteristics, population characteristics, outcomes, and quality indicators. Intervention characteristics (eg, synchronicity and guidance) were examined as potential factors related to study outcomes. Results: Of 435 publications screened, 19 published papers describing 16 studies were included. They examined Web-based MBIs for people with cancer, chronic pain or fibromyalgia, irritable bowel syndrome (IBS), epilepsy, heart disease, tinnitus, and acquired brain injury. Overall, most studies reported positive effects of Web-based MBIs compared with usual care on a variety of outcomes including pain acceptance, coping measures, and depressive symptoms. There were mixed results regarding the effectiveness of Web-based MBIs compared with active control treatment conditions such as cognitive behavioral therapy. Condition-specific symptoms (eg, cancer-related fatigue and IBS symptoms) targeted by treatment had the largest effect size improvements following MBIs. Results are inconclusive regarding physical variables. Conclusions: Preliminary evidence suggests that Web-based MBIs may be helpful in alleviating symptom burden that those with physical health conditions can experience, particularly when interventions are tailored for specific symptoms. There was no evidence of differences between synchronous versus asynchronous or facilitated versus self-directed Web-based MBIs. Future investigations of Web-based MBIs should evaluate the effects of program adherence, effects on mindfulness levels, and whether synchronous or asynchronous, or facilitated or self-directed interventions elicit greater improvements. UR - https://www.jmir.org/2017/8/e303/ UR - http://dx.doi.org/10.2196/jmir.7487 UR - http://www.ncbi.nlm.nih.gov/pubmed/28860106 ID - info:doi/10.2196/jmir.7487 ER - TY - JOUR AU - Mistler, A. Lisa AU - Ben-Zeev, Dror AU - Carpenter-Song, Elizabeth AU - Brunette, F. Mary AU - Friedman, J. Matthew PY - 2017/08/21 TI - Mobile Mindfulness Intervention on an Acute Psychiatric Unit: Feasibility and Acceptability Study JO - JMIR Ment Health SP - e34 VL - 4 IS - 3 KW - mindfulness KW - meditation KW - mHealth KW - psychiatry KW - mobile phone KW - aggression KW - violence KW - schizophrenia KW - bipolar disorder KW - psychotic disorders N2 - Background: Aggression and violence on acute psychiatric inpatient units is extensive and leads to negative sequelae for staff and patients. With increasingly acute inpatient milieus due to shorter lengths of stay, inpatient staff is limited in training and time to be able to provide treatments. Mobile technology provides a new platform for offering treatment on such units, but it has not been tested for feasibility or usability in this particular setting. Objective: The aim of this study was to examine the feasibility, usability, and acceptability of a brief mindfulness meditation mobile phone app intended to reduce anger and aggression in acute psychiatric inpatients with schizophrenia, schizoaffective disorder, or bipolar disorder, and a history of violence. Methods: Participants were recruited between November 1, 2015 and June 1, 2016. A total of 13 inpatients at an acute care state hospital carried mobile phones for 1 week and were asked to try a commercially available mindfulness app called Headspace. The participants completed a usability questionnaire and engaged in a qualitative interview upon completion of the 7 days. In addition, measures of mindfulness, state and trait anger, and cognitive ability were administered before and after the intervention. Results: Of the 13 enrolled participants, 10 used the app for the 7 days of the study and completed all measures. Two additional participants used the app for fewer than 7 days and completed all measures. All participants found the app to be engaging and easy to use. Most (10/12, 83%) felt comfortable using Headspace and 83% (10/12) would recommend it to others. All participants made some effort to try the app, with 6 participants (6/12, 50%) completing the first 10 10-minute ?foundation? guided meditations. Conclusions: This is the first known study of the use of a commercially available app as an intervention on acute psychiatric inpatient units. Acutely ill psychiatric inpatients at a state hospital found the Headspace app easy to use, were able to complete a series of meditations, and felt the app helped with anxiety, sleep, and boredom on the unit. There were no instances of an increase in psychotic symptoms reported and there were no episodes of aggression or violence noted in the record. UR - http://mental.jmir.org/2017/3/e34/ UR - http://dx.doi.org/10.2196/mental.7717 UR - http://www.ncbi.nlm.nih.gov/pubmed/28827214 ID - info:doi/10.2196/mental.7717 ER - TY - JOUR AU - Zhu, Bin AU - Hedman, Anders AU - Feng, Shuo AU - Li, Haibo AU - Osika, Walter PY - 2017/06/14 TI - Designing, Prototyping and Evaluating Digital Mindfulness Applications: A Case Study of Mindful Breathing for Stress Reduction JO - J Med Internet Res SP - e197 VL - 19 IS - 6 KW - respiration KW - biofeedback KW - mindfulness KW - stress KW - device design KW - sound KW - light KW - breathing KW - heart rate KW - relaxation N2 - Background: During the past decade, there has been a rapid increase of interactive apps designed for health and well-being. Yet, little research has been published on developing frameworks for design and evaluation of digital mindfulness facilitating technologies. Moreover, many existing digital mindfulness applications are purely software based. There is room for further exploration and assessment of designs that make more use of physical qualities of artifacts. Objective: The study aimed to develop and test a new physical digital mindfulness prototype designed for stress reduction. Methods: In this case study, we designed, developed, and evaluated HU, a physical digital mindfulness prototype designed for stress reduction. In the first phase, we used vapor and light to support mindful breathing and invited 25 participants through snowball sampling to test HU. In the second phase, we added sonification. We deployed a package of probes such as photos, diaries, and cards to collect data from users who explored HU in their homes. Thereafter, we evaluated our installation using both self-assessed stress levels and heart rate (HR) and heart rate variability (HRV) measures in a pilot study, in order to measure stress resilience effects. After the experiment, we performed a semistructured interview to reflect on HU and investigate the design of digital mindfulness apps for stress reduction. Results: The results of the first phase showed that 22 of 25 participants (88%) claimed vapor and light could be effective ways of promoting mindful breathing. Vapor could potentially support mindful breathing better than light (especially for mindfulness beginners). In addition, a majority of the participants mentioned sound as an alternative medium. In the second phase, we found that participants thought that HU could work well for stress reduction. We compared the effect of silent HU (using light and vapor without sound) and sonified HU on 5 participants. Subjective stress levels were statistically improved with both silent and sonified HU. The mean value of HR using silent HU was significantly lower than resting baseline and sonified HU. The mean value of root mean square of differences (RMSSD) using silent HU was significantly higher than resting baseline. We found that the differences between our objective and subjective assessments were intriguing and prompted us to investigate them further. Conclusions: Our evaluation of HU indicated that HU could facilitate relaxed breathing and stress reduction. There was a difference in outcome between the physiological measures of stress and the subjective reports of stress, as well as a large intervariability among study participants. Our conclusion is that the use of stress reduction tools should be customized and that the design work of mindfulness technology for stress reduction is a complex process, which requires cooperation of designers, HCI (Human-Computer Interaction) experts and clinicians. UR - http://www.jmir.org/2017/6/e197/ UR - http://dx.doi.org/10.2196/jmir.6955 UR - http://www.ncbi.nlm.nih.gov/pubmed/28615157 ID - info:doi/10.2196/jmir.6955 ER - TY - JOUR AU - Kraft, Susanne AU - Wolf, Markus AU - Klein, Thomas AU - Becker, Thomas AU - Bauer, Stephanie AU - Puschner, Bernd PY - 2017/05/02 TI - Text Message Feedback to Support Mindfulness Practice in People With Depressive Symptoms: A Pilot Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e59 VL - 5 IS - 5 KW - mindfulness KW - text messaging KW - pilot study KW - randomized controlled trial N2 - Background: It has been shown that mindfulness practice can be helpful in preventing relapse from depression. However, practicing mindfulness regularly at home is often a challenge for people with depression. Mobile phone text messaging (short message service, SMS) may be a feasible approach to assist regular mindfulness home practice. Objective: The aim of this study was to evaluate the feasibility of text message?based feedback to support mindfulness practice in people with depressive symptoms after inpatient psychiatric treatment. Methods: Participants received a manualized group introduction to three mindfulness exercises during inpatient treatment and were randomized at hospital discharge. All participants were asked to practice the exercises daily during the 4-month follow-up period. Only participants allocated to the intervention group received reinforcing feedback via mobile phone text messages after reporting their mindfulness practice via text message. Participation rates and satisfaction with the interventions were evaluated, and effects on relevant outcomes were explored. Results: Of the 176 eligible inpatients invited to participate, 65.9% (116/176) attended the introductory mindfulness group at least once, 33.0% (58/176) were willing to participate in the study, and 41 were randomized. The majority 85% (35/41) of these participants completed the study. Among the participants allocated to the intervention group (n=21), 81% (17/21) used the text message support at least once. The average number of text messages sent during the intervention period was 14 (SD 21, range 0-91). Satisfaction rates were high. Preliminary analyses of the effects of the intervention yielded mixed results. Conclusions: Findings indicate that text messaging following inpatient treatment is feasible for some, but not for all people with depressive symptoms. Modest use of the text messaging intervention and its mixed effects imply that dose and ingredients of the intervention should be increased for this group of patients in a future full-size RCT. Such a larger study should also include a process evaluation to investigate moderators of the effect of mindfulness practice and text message feedback on clinical outcome. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 58808893; http://www.controlled-trials.com/ISRCTN58808893 (Archived by Webcite at http://www.webcitation.org/6pmrDRnGt) UR - http://mhealth.jmir.org/2017/5/e59/ UR - http://dx.doi.org/10.2196/mhealth.7095 UR - http://www.ncbi.nlm.nih.gov/pubmed/28465278 ID - info:doi/10.2196/mhealth.7095 ER - TY - JOUR AU - Turner, Tami AU - Hingle, Melanie PY - 2017/04/26 TI - Evaluation of a Mindfulness-Based Mobile App Aimed at Promoting Awareness of Weight-Related Behaviors in Adolescents: A Pilot Study JO - JMIR Res Protoc SP - e67 VL - 6 IS - 4 KW - mindfulness KW - adolescent KW - mHealth KW - diet KW - physical activity KW - app N2 - Background: Mindfulness-based interventions are reported to be highly acceptable and have positive effects on youth, yet most are clinic- or school-based aimed at emotional regulation or academic performance. To provide flexible program delivery, we developed and tested a standalone mindfulness-based app aimed at improving weight-related behaviors (eg, diet, physical activity, sleep) in adolescents. Objective: Our objective was to assess the feasibility, acceptability, and utility of a mindfulness-based mobile app. Methods: In a single-arm pilot study, 15 adolescents (14-18 years) were prompted to access the app once a day, every day for 6 weeks. Outcomes were measured by in-app and poststudy surveys, and descriptive statistical analyses were performed. Time within a mindfulness state was self-reported during weekly timed practices. Results: The app was rated highly for content and encouraging the practice of activities to promote mindfulness states. Teens reported increased awareness of eating behaviors and high adherence, particularly during physically active practices. Average self-reported time spent in a mindfulness state increased 2.5 times by week 6 (78 [SD 17] seconds) compared to week 1 (31 [SD 21] seconds). Conclusions: The high acceptability and utility ratings of the app, increases in reported time in mindfulness states, and high frequency of participation, including mindful eating and physical activity, suggest the mindfulness-based mobile app has the potential to improve awareness of weight-related behaviors. UR - http://www.researchprotocols.org/2017/4/e67/ UR - http://dx.doi.org/10.2196/resprot.6695 UR - http://www.ncbi.nlm.nih.gov/pubmed/28446423 ID - info:doi/10.2196/resprot.6695 ER - TY - JOUR AU - Mak, WS Winnie AU - Chio, HN Floria AU - Chan, TY Amy AU - Lui, WS Wacy AU - Wu, KY Ellery PY - 2017/03/22 TI - The Efficacy of Internet-Based Mindfulness Training and Cognitive-Behavioral Training With Telephone Support in the Enhancement of Mental Health Among College Students and Young Working Adults: Randomized Controlled Trial JO - J Med Internet Res SP - e84 VL - 19 IS - 3 KW - mental health promotion KW - Internet-based interventions KW - mindfulness-based training KW - cognitive-behavioral training KW - randomized controlled trial N2 - Background: College students and working adults are particularly vulnerable to stress and other mental health problems, and mental health promotion and prevention are needed to promote their mental health. In recent decades, mindfulness-based training has demonstrated to be efficacious in treating physical and psychological conditions. Objective: The aim of our study was to examine the efficacy of an Internet-based mindfulness training program (iMIND) in comparison with the well-established Internet-based cognitive-behavioral training program (iCBT) in promoting mental health among college students and young working adults. Methods: This study was a 2-arm, unblinded, randomized controlled trial comparing iMIND with iCBT. Participants were recruited online and offline via mass emails, advertisements in newspapers and magazines, announcement and leaflets in primary care clinics, and social networking sites. Eligible participants were randomized into either the iMIND (n=604) or the iCBT (n=651) condition. Participants received 8 Web-based sessions with information and exercises related to mindfulness or cognitive-behavioral principles. Telephone or email support was provided by trained first tier supporters who were supervised by the study?s research team. Primary outcomes included mental and physical health-related measures, which were self-assessed online at preprogram, postprogram, and 3-month follow-up. Results: Among the 1255 study participants, 213 and 127 completed the post- and 3-month follow-up assessment, respectively. Missing data were treated using restricted maximum likelihood estimation. Both iMIND (n=604) and iCBT (n=651) were efficacious in improving mental health, psychological distress, life satisfaction, sleep disturbance, and energy level. Conclusions: Both Internet-based mental health programs showed potential in improving the mental health from pre- to postassessment, and such improvement was sustained at the 3-month follow-up. The high attrition rate in this study suggests the need for refinement in future technology-based psychological programs. Mental health professionals need to team up with experts in information technology to increase personalization of Web-based interventions to enhance adherence. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12002623; https://www2.ccrb.cuhk.edu.hk/ registry/public/191 (Archived by WebCite at http://www.webcitation.org/6kxt8DjM4). UR - http://www.jmir.org/2017/3/e84/ UR - http://dx.doi.org/10.2196/jmir.6737 UR - http://www.ncbi.nlm.nih.gov/pubmed/28330831 ID - info:doi/10.2196/jmir.6737 ER - TY - JOUR AU - Wahbeh, Helané AU - Oken, S. Barry PY - 2016/08/08 TI - Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial JO - JMIR Ment Health SP - e37 VL - 3 IS - 3 KW - Internet KW - mindfulness KW - meditation KW - behavior modification KW - controlled trial N2 - Background: Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives: The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI?s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods: Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants? own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys. Results: We enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes. Conclusions: In conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI?s efficacy at improving health outcomes in the general population and also compare it directly to the well-studied mindfulness-based group interventions to evaluate relative efficacy. Trial Registration: Clinicaltrials.gov NCT02655835; http://clinicaltrials.gov/ct2/show/NCT02655835 (Archived by WebCite at http://www.webcitation/ 6jUDuQsG2) UR - http://mental.jmir.org/2016/3/e37/ UR - http://dx.doi.org/10.2196/mental.5900 UR - http://www.ncbi.nlm.nih.gov/pubmed/27502759 ID - info:doi/10.2196/mental.5900 ER - TY - JOUR AU - Kvillemo, Pia AU - Brandberg, Yvonne AU - Bränström, Richard PY - 2016/07/22 TI - Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial JO - JMIR Ment Health SP - e33 VL - 3 IS - 3 KW - mindfulness KW - Internet-based intervention KW - Internet KW - usability KW - acceptability KW - feasibility KW - randomized controlled trial N2 - Background: Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. Objective: This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Methods: Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant?s experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. Results: In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice. Conclusions: The program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance. ClinicalTrial: ClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4) UR - http://mental.jmir.org/2016/3/e33/ UR - http://dx.doi.org/10.2196/mental.5457 UR - http://www.ncbi.nlm.nih.gov/pubmed/27450466 ID - info:doi/10.2196/mental.5457 ER - TY - JOUR AU - Mani, Madhavan AU - Kavanagh, J. David AU - Hides, Leanne AU - Stoyanov, R. Stoyan PY - 2015/08/19 TI - Review and Evaluation of Mindfulness-Based iPhone Apps JO - JMIR mHealth uHealth SP - e82 VL - 3 IS - 3 KW - mindfulness KW - mindfulness-based mobile apps KW - mobile health (mHealth) KW - mental health N2 - Background: There is growing evidence for the positive impact of mindfulness on wellbeing. Mindfulness-based mobile apps may have potential as an alternative delivery medium for training. While there are hundreds of such apps, there is little information on their quality. Objective: This study aimed to conduct a systematic review of mindfulness-based iPhone mobile apps and to evaluate their quality using a recently-developed expert rating scale, the Mobile Application Rating Scale (MARS). It also aimed to describe features of selected high-quality mindfulness apps. Methods: A search for ?mindfulness? was conducted in iTunes and Google Apps Marketplace. Apps that provided mindfulness training and education were included. Those containing only reminders, timers or guided meditation tracks were excluded. An expert rater reviewed and rated app quality using the MARS engagement, functionality, visual aesthetics, information quality and subjective quality subscales. A second rater provided MARS ratings on 30% of the apps for inter-rater reliability purposes. Results: The ?mindfulness? search identified 700 apps. However, 94 were duplicates, 6 were not accessible and 40 were not in English. Of the remaining 560, 23 apps met inclusion criteria and were reviewed. The median MARS score was 3.2 (out of 5.0), which exceeded the minimum acceptable score (3.0). The Headspace app had the highest average score (4.0), followed by Smiling Mind (3.7), iMindfulness (3.5) and Mindfulness Daily (3.5). There was a high level of inter-rater reliability between the two MARS raters. Conclusions: Though many apps claim to be mindfulness-related, most were guided meditation apps, timers, or reminders. Very few had high ratings on the MARS subscales of visual aesthetics, engagement, functionality or information quality. Little evidence is available on the efficacy of the apps in developing mindfulness. UR - http://mhealth.jmir.org/2015/3/e82/ UR - http://dx.doi.org/10.2196/mhealth.4328 UR - http://www.ncbi.nlm.nih.gov/pubmed/26290327 ID - info:doi/10.2196/mhealth.4328 ER - TY - JOUR AU - Mak, WS Winnie AU - Chan, TY Amy AU - Cheung, YL Eliza AU - Lin, LY Cherry AU - Ngai, CS Karin PY - 2015/01/19 TI - Enhancing Web-Based Mindfulness Training for Mental Health Promotion With the Health Action Process Approach: Randomized Controlled Trial JO - J Med Internet Res SP - e8 VL - 17 IS - 1 KW - Internet-based intervention KW - online intervention KW - mindfulness KW - Health Action Process Approach (HAPA) KW - mental health promotion N2 - Background: With increasing evidence demonstrating the effectiveness of Web-based interventions and mindfulness-based training in improving health, delivering mindfulness training online is an attractive proposition. Objective: The aim of this study was to evaluate the efficacy of two Internet-based interventions (basic mindfulness and Health Action Process Approach enhanced mindfulness) with waitlist control. Health Action Process Approach (HAPA) principles were used to enhance participants? efficacy and planning. Methods: Participants were recruited online and offline among local universities; 321 university students and staff were randomly assigned to three conditions. The basic and HAPA-enhanced groups completed the 8-week fully automated mindfulness training online. All participants (including control) were asked to complete an online questionnaire pre-program, post-program, and at 3-month follow-up. Results: Significant group by time interaction effect was found. The HAPA-enhanced group showed significantly higher levels of mindfulness from pre-intervention to post-intervention, and such improvement was sustained at follow-up. Both the basic and HAPA-enhanced mindfulness groups showed better mental well-being from pre-intervention to post-intervention, and improvement was sustained at 3-month follow-up. Conclusions: Online mindfulness training can improve mental health. An online platform is a viable medium to implement and disseminate evidence-based interventions and is a highly scalable approach to reach the general public. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR-TRC-12002954; http://www.chictr.org/en/proj/show.aspx?proj=3904 (Archived by WebCite at http://www.webcitation.org/6VCdG09pA). UR - http://www.jmir.org/2015/1/e8/ UR - http://dx.doi.org/10.2196/jmir.3746 UR - http://www.ncbi.nlm.nih.gov/pubmed/25599904 ID - info:doi/10.2196/jmir.3746 ER - TY - JOUR AU - Plaza, Inmaculada AU - Demarzo, Piva Marcelo Marcos AU - Herrera-Mercadal, Paola AU - García-Campayo, Javier PY - 2013/11/01 TI - Mindfulness-Based Mobile Applications: Literature Review and Analysis of Current Features JO - JMIR Mhealth Uhealth SP - e24 VL - 1 IS - 2 KW - mobile health KW - mHealth KW - mindfulness KW - social networks KW - personalized education KW - health informatics KW - evidence-based medicine N2 - Background: Interest in mindfulness has increased exponentially, particularly in the fields of psychology and medicine. The trait or state of mindfulness is significantly related to several indicators of psychological health, and mindfulness-based therapies are effective at preventing and treating many chronic diseases. Interest in mobile applications for health promotion and disease self-management is also growing. Despite the explosion of interest, research on both the design and potential uses of mindfulness-based mobile applications (MBMAs) is scarce. Objective: Our main objective was to study the features and functionalities of current MBMAs and compare them to current evidence-based literature in the health and clinical setting. Methods: We searched online vendor markets, scientific journal databases, and grey literature related to MBMAs. We included mobile applications that featured a mindfulness-based component related to training or daily practice of mindfulness techniques. We excluded opinion-based articles from the literature. Results: The literature search resulted in 11 eligible matches, two of which completely met our selection criteria?a pilot study designed to evaluate the feasibility of a MBMA to train the practice of ?walking meditation,? and an exploratory study of an application consisting of mood reporting scales and mindfulness-based mobile therapies. The online market search eventually analyzed 50 available MBMAs. Of these, 8% (4/50) did not work, thus we only gathered information about language, downloads, or prices. The most common operating system was Android. Of the analyzed apps, 30% (15/50) have both a free and paid version. MBMAs were devoted to daily meditation practice (27/46, 59%), mindfulness training (6/46, 13%), assessments or tests (5/46, 11%), attention focus (4/46, 9%), and mixed objectives (4/46, 9%). We found 108 different resources, of which the most used were reminders, alarms, or bells (21/108, 19.4%), statistics tools (17/108, 15.7%), audio tracks (15/108, 13.9%), and educational texts (11/108, 10.2%). Daily, weekly, monthly statistics, or reports were provided by 37% (17/46) of the apps. 28% (13/46) of them permitted access to a social network. No information about sensors was available. The analyzed applications seemed not to use any external sensor. English was the only language of 78% (39/50) of the apps, and only 8% (4/50) provided information in Spanish. 20% (9/46) of the apps have interfaces that are difficult to use. No specific apps exist for professionals or, at least, for both profiles (users and professionals). We did not find any evaluations of health outcomes resulting from the use of MBMAs. Conclusions: While a wide selection of MBMAs seem to be available to interested people, this study still shows an almost complete lack of evidence supporting the usefulness of those applications. We found no randomized clinical trials evaluating the impact of these applications on mindfulness training or health indicators, and the potential for mobile mindfulness applications remains largely unexplored. UR - http://mhealth.jmir.org/2013/2/e24/ UR - http://dx.doi.org/10.2196/mhealth.2733 UR - http://www.ncbi.nlm.nih.gov/pubmed/25099314 ID - info:doi/10.2196/mhealth.2733 ER -