@Article{info:doi/10.2196/68665, author="Staiano, Walter and Callahan, Christine and Davis, Michelle and Tanner, Leah and Coe, Chelsea and Kunkle, Sarah and Kirk, Ulrich", title="Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2025", month="Apr", day="23", volume="13", pages="e68665", keywords="cognitive behavioral therapy for insomnia", keywords="mindfulness", keywords="randomized controlled trial", keywords="RCT", keywords="therapy", keywords="insomnia", keywords="behavioral", keywords="app based", keywords="app", abstract="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, $\eta${\texttwosuperior}p=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, $\eta${\texttwosuperior}p=.03) and actigraphy outcomes (P=.01, $\eta${\texttwosuperior}p=.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, $\eta${\texttwosuperior}p=.04), anxiety symptoms (P=.02, $\eta${\texttwosuperior}p=.02), and mindfulness (P=.01, $\eta${\texttwosuperior}p=.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 ", doi="10.2196/68665", url="https://mhealth.jmir.org/2025/1/e68665" } @Article{info:doi/10.2196/68204, author="Treves, Isaac and Bajwa, Zia and Greene, D. Keara and Bloom, A. Paul and Kim, Nayoung and Wool, Emma and Goldberg, B. Simon and Whitfield-Gabrieli, Susan and Auerbach, P. Randy", title="Consumer-Grade Neurofeedback With Mindfulness Meditation: Meta-Analysis", journal="J Med Internet Res", year="2025", month="Apr", day="17", volume="27", pages="e68204", keywords="neurofeedback", keywords="mindfulness", keywords="device", keywords="neurotechnology", keywords="meditation", keywords="stress", keywords="cognition", keywords="Muse", keywords="consumer grade", keywords="meta-analyses", keywords="neuroscientific technology", keywords="neurotechnologies", keywords="randomized", abstract="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. ", doi="10.2196/68204", url="https://www.jmir.org/2025/1/e68204" } @Article{info:doi/10.2196/65188, author="Fleszar-Pavlovic, E. Sara and Noriega Esquives, Blanca and Lovan, Padideh and Brito, E. Arianna and Sia, Marie Ann and Kauffman, Adelyn Mary and Lopes, Maria and Moreno, I. Patricia and Koru-Sengul, Tulay and Gong, Rui and Wang, Trent and Wieder, D. Eric and Rueda-Lara, Maria and Antoni, Michael and Komanduri, Krishna and Lesiuk, Teresa and Penedo, J. Frank", title="Development of an eHealth Mindfulness-Based Music Therapy Intervention for Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: Qualitative Study", journal="JMIR Form Res", year="2025", month="Apr", day="11", volume="9", pages="e65188", keywords="allogeneic stem cell transplantation", keywords="hematologic malignancy", keywords="bone marrow transplant", keywords="mindfulness-based music therapy", keywords="mindfulness", keywords="music therapy", keywords="eHealth", keywords="music therapy intervention", keywords="adult", keywords="adolescence", keywords="allogeneic", keywords="stem cell transplantation", keywords="stem cell", keywords="transplantation", keywords="qualitative study", keywords="treatment", keywords="hematologic cancers", keywords="psychological distress", keywords="side effects", keywords="mindfulness-based stress reduction", keywords="stress reduction", keywords="anxiety", keywords="depression", keywords="diagnosis", keywords="blood sample collection", keywords="eHealth tool", keywords="quality of life", keywords="cancer survivors", abstract="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 ", doi="10.2196/65188", url="https://formative.jmir.org/2025/1/e65188" } @Article{info:doi/10.2196/64174, author="Laverdi{\`e}re, Roxanne and Jackson, L. Philip and Banville, Fr{\'e}d{\'e}ric", title="A New Mobile App to Train Attention Processes in People With Traumatic Brain Injury: Logical and Ecological Content Validation Study", journal="JMIR Form Res", year="2025", month="Apr", day="9", volume="9", pages="e64174", keywords="mobile app", keywords="attention training", keywords="cognitive remediation", keywords="mindfulness", keywords="psychometric properties", keywords="content validation", abstract="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. Laverdi{\`e}re 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. ", doi="10.2196/64174", url="https://formative.jmir.org/2025/1/e64174", url="http://www.ncbi.nlm.nih.gov/pubmed/40202789" } @Article{info:doi/10.2196/54062, author="Lalk, Christopher and V{\"a}th, Teresa and Hanraths, Sofie and Pruessner, Luise and Timm, Christina and Hartmann, Steffen and Barnow, Sven and Rubel, Julian", title="Evaluation of an Online-Based Self-Help Program for Patients With Panic Disorder: Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Apr", day="2", volume="27", pages="e54062", keywords="internet-based CBT", keywords="agoraphobia", keywords="well-being", keywords="iCBT", keywords="internet-based intervention", keywords="panic disorder with and without agoraphobia", keywords="panic disorder", keywords="self-help", keywords="quality of life", keywords="effectiveness", keywords="online", keywords="self-help intervention", keywords="panic symptoms", keywords="daily functioning", abstract="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 ", doi="10.2196/54062", url="https://www.jmir.org/2025/1/e54062" } @Article{info:doi/10.2196/65786, author="Kim, Jaehyun and Oh, Hayoung and Yoon, Sungmin Anderson", title="Mindfulness-Based Cognitive Therapy--Game: An Ironic Way to Treat Internet Gaming Disorder", journal="J Med Internet Res", year="2025", month="Mar", day="27", volume="27", pages="e65786", keywords="cognitive behavior therapy", keywords="psychosocial intervention", keywords="video games", keywords="internet gaming disorder", keywords="internet addiction", keywords="mindfulness", keywords="mental health", doi="10.2196/65786", url="https://www.jmir.org/2025/1/e65786" } @Article{info:doi/10.2196/69120, author="Saskovets, Marina and Saponkova, Irina and Liang, Zilu", title="Effects of Sound Interventions on the Mental Stress Response in Adults: Scoping Review", journal="JMIR Ment Health", year="2025", month="Mar", day="24", volume="12", pages="e69120", keywords="mental stress", keywords="anxiety", keywords="sound therapy", keywords="music therapy", keywords="psychoacoustics", keywords="expressive sounds", keywords="stress reduction", keywords="stress management", keywords="stress relief", keywords="stress markers", keywords="relaxation", keywords="personalized therapy", keywords="PRISMA", abstract="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 ", doi="10.2196/69120", url="https://mental.jmir.org/2025/1/e69120" } @Article{info:doi/10.2196/67000, author="Lai, Yi-Jen and Chiu, Hsiao-Yean and Wu, Ko-Chiu and Chang, Chun-Wei", title="Diaphragmatic Breathing Interfaces to Promote Relaxation for Mitigating Insomnia: Pilot Study", journal="JMIR Serious Games", year="2025", month="Mar", day="4", volume="13", pages="e67000", keywords="brief behavioral treatment for insomnia", keywords="sleep self-efficacy", keywords="mobile health", keywords="mHealth", keywords="breathing training cognitive load", keywords="attention", keywords="gamification", keywords="diaphragmatic breathing", keywords="insomnia", keywords="sleep", keywords="games", keywords="relaxation", keywords="breathing", keywords="breathing guidance", keywords="questionnaire", keywords="mental", keywords="cognition", abstract="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. ", doi="10.2196/67000", url="https://games.jmir.org/2025/1/e67000", url="http://www.ncbi.nlm.nih.gov/pubmed/40053714" } @Article{info:doi/10.2196/55583, author="Zhu, Tingfei and Zhang, Liuyi and Weng, Wenqi and Gan, Ruochen and Sun, Limin and Wei, Yanping and Zhu, Yueping and Yu, Hongyan and Xue, Jiang and Chen, Shulin", title="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", journal="J Med Internet Res", year="2025", month="Feb", day="13", volume="27", pages="e55583", keywords="internet-based", keywords="self-guided", keywords="short-term", keywords="mindfulness", keywords="depression", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/55583", url="https://www.jmir.org/2025/1/e55583" } @Article{info:doi/10.2196/62663, author="Verstegen, Amandine and Van Daele, Tom and Bonroy, Bert and Debard, Glen and Sels, Romy and van Loo, Marlon and Bernaerts, Sylvie", title="Designing a Smartphone-Based Virtual Reality App for Relaxation: Qualitative Crossover Study", journal="JMIR Form Res", year="2025", month="Feb", day="13", volume="9", pages="e62663", keywords="smartphone-based virtual reality", keywords="virtual reality", keywords="relaxation", keywords="stress", keywords="user experience", keywords="mobile phone", abstract="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. ", doi="10.2196/62663", url="https://formative.jmir.org/2025/1/e62663" } @Article{info:doi/10.2196/65206, author="Klein Haneveld, Lisa and Dekkers, Tessa and Bouman, A. Yvonne H. and Scholten, Hanneke and Weerdmeester, Joanneke and Kelders, M. Saskia and Kip, Hanneke", title="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", journal="JMIR Form Res", year="2025", month="Feb", day="12", volume="9", pages="e65206", keywords="virtual reality", keywords="VR", keywords="diaphragmatic breathing", keywords="biofeedback", keywords="DEEP", keywords="forensic psychiatry", keywords="mental health", keywords="stress", keywords="single-case experimental design", keywords="experience sampling method", abstract="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 ($\beta$=--.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 ($\beta$=--.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 ($\beta$=--.012; P=.006), stress ($\beta$=--.014; P=.007), and anger ($\beta$=--.007; P=.02) over time. They also reported short-term experienced effects in the interview. P6 showed a significant decline of stress over time ($\beta$=--.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. ", doi="10.2196/65206", url="https://formative.jmir.org/2025/1/e65206" } @Article{info:doi/10.2196/59653, author="L{\'o}pez-del-Hoyo, Yolanda and Fern{\'a}ndez-Mart{\'i}nez, Selene and Perez-Aranda, Adrian and Monreal-Bartolom{\'e}, Alicia and Barcel{\'o}-Soler, Alberto and Camarero-Grados, Loreto and Armas-Landaeta, Carilene and Guzm{\'a}n-Parra, Jos{\'e} and Carbonell, Vera and Campos, Daniel and Chen, Xinyuan and Garc{\'i}a-Campayo, Javier", title="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", journal="J Med Internet Res", year="2025", month="Feb", day="3", volume="27", pages="e59653", keywords="eHealth", keywords="health professionals", keywords="stress", keywords="mental health", keywords="stress reduction", keywords="web-based intervention", keywords="stepped-wedge design", keywords="randomized controlled trial", abstract="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 M{\'a}laga, 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 ($\beta$=--1.08, SE 0.51; P=.03) and the sample of completers ($\beta$=--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 ", doi="10.2196/59653", url="https://www.jmir.org/2025/1/e59653", url="http://www.ncbi.nlm.nih.gov/pubmed/39899345" } @Article{info:doi/10.2196/69554, author="Gu, Chenyu and Qian, Liquan and Zhuo, Xiaojie", title="Mindfulness Intervention for Health Information Avoidance in Older Adults: Mixed Methods Study", journal="JMIR Public Health Surveill", year="2025", month="Jan", day="28", volume="11", pages="e69554", keywords="health information avoidance", keywords="cyberchondria", keywords="self-determination theory", keywords="mindfulness", keywords="elderly", abstract="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 ($\beta$=.26, P=.002), health self-efficacy ($\beta$=.25, P<.001), and health information similarity ($\beta$=.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 ($\beta$=?.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. ", doi="10.2196/69554", url="https://publichealth.jmir.org/2025/1/e69554" } @Article{info:doi/10.2196/63197, author="Antico, Lia and Brewer, Judson", title="Digital Mindfulness Training for Burnout Reduction in Physicians: Clinician-Driven Approach", journal="JMIR Form Res", year="2025", month="Jan", day="24", volume="9", pages="e63197", keywords="burnout", keywords="anxiety", keywords="empathy fatigue", keywords="physician", keywords="mindfulness", keywords="digital therapeutics", keywords="app", keywords="smartphone", keywords="podcast", keywords="compassion", keywords="health care provider", keywords="training", keywords="physician burnout", keywords="cynicism", keywords="efficacy", keywords="treatment", keywords="meditation", keywords="chronic", keywords="workplace stress", keywords="digital health", keywords="mHealth", keywords="mobile phone", abstract="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 ", doi="10.2196/63197", url="https://formative.jmir.org/2025/1/e63197" } @Article{info:doi/10.2196/58265, author="Rizzi, Silvia and Pavesi, Chiara Maria and Moser, Alessia and Paolazzi, Francesca and Marchesoni, Michele and Poggianella, Stefania and Gadotti, Erik and Forti, Stefano", title="A Mindfulness-Based App Intervention for Pregnant Women: Qualitative Evaluation of a Prototype Using Multiple Case Studies", journal="JMIR Form Res", year="2025", month="Jan", day="17", volume="9", pages="e58265", keywords="mindfulness", keywords="promoting well-being", keywords="pregnancy", keywords="eHealth", keywords="mHealth", keywords="mobile apps", keywords="development", keywords="usability", keywords="user-centered design", keywords="well-being", keywords="maternal health", keywords="digital health", keywords="intervention", keywords="design", keywords="preliminary testing", keywords="technology-based", keywords="interview", keywords="multidisciplinary approach", keywords="mother", keywords="women", keywords="WhatsApp", keywords="email", keywords="midwife", abstract="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. ", doi="10.2196/58265", url="https://formative.jmir.org/2025/1/e58265" } @Article{info:doi/10.2196/56601, author="Park, Sehwan and Cho, Young Hee and Park, Young Jin and Chung, Kyungmi and Jhung, Kyungun", title="Development and Evaluation of a Mindfulness-Based Mobile Intervention for Perinatal Mental Health: Randomized Controlled Trial", journal="J Med Internet Res", year="2025", month="Jan", day="17", volume="27", pages="e56601", keywords="anxiety", keywords="perinatal mental health", keywords="depression", keywords="mobile health care", keywords="mindfulness", keywords="mobile phone", abstract="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 ", doi="10.2196/56601", url="https://www.jmir.org/2025/1/e56601" } @Article{info:doi/10.2196/54154, author="Komariah, Maria and Maulana, Sidik and Amirah, Shakira and Platini, Hesti and Rahayuwati, Laili and Yusuf, Ah and Firdaus, Hasymi Mohd Khairul Zul", title="Benefits of Remote-Based Mindfulness on Physical Symptom Outcomes in Cancer Survivors: Systematic Review and Meta-Analysis", journal="JMIR Cancer", year="2025", month="Jan", day="16", volume="11", pages="e54154", keywords="cancer", keywords="physical symptoms", keywords="mindfulness", keywords="remote-based intervention", keywords="quality of life", abstract="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. ", doi="10.2196/54154", url="https://cancer.jmir.org/2025/1/e54154" } @Article{info:doi/10.2196/52764, author="Holley, Dan and Brooks, Amanda and Hartz, Matthew and Rao, Sudhir and Zaubler, Thomas", title="mHealth-Augmented Care for Reducing Depression Symptom Severity Among Patients With Chronic Pain: Exploratory, Retrospective Cohort Study", journal="JMIR Mhealth Uhealth", year="2025", month="Jan", day="10", volume="13", pages="e52764", keywords="mHealth", keywords="mobile health", keywords="app", keywords="behavioral health care", keywords="depression", keywords="mental health", keywords="screening", keywords="pain", keywords="chronic pain", keywords="psychiatric screenings", keywords="digital health care", keywords="psychiatry", keywords="psychiatric", keywords="longitudinal", keywords="assessment", keywords="behavioral", keywords="self-help", keywords="integrated", keywords="comorbidity", keywords="augmented care", abstract="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. ", doi="10.2196/52764", url="https://mhealth.jmir.org/2025/1/e52764" } @Article{info:doi/10.2196/59093, author="Zhang, Lin and Huang, Shuang and Liu, Sha and Huang, Yuanxiu and Chen, Shan and Hu, Jinsong and Xu, Mingzhong", title="Effectiveness of an Internet-Based Acceptance and Commitment Therapy Intervention for Reducing Psychological Distress in Health Care Professionals: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Dec", day="18", volume="26", pages="e59093", keywords="acceptance and commitment therapy", keywords="internet-based intervention", keywords="stress", keywords="anxiety", keywords="depression", keywords="burnout", keywords="health care professionals", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/59093", url="https://www.jmir.org/2024/1/e59093", url="http://www.ncbi.nlm.nih.gov/pubmed/39693127" } @Article{info:doi/10.2196/63760, author="Anto, Ailin and Basu, Arunima and Selim, Rania and Foscht, Thomas and Eisingerich, Benedikt Andreas", title="Open-World Games' Affordance of Cognitive Escapism, Relaxation, and Mental Well-Being Among Postgraduate Students: Mixed Methods Study", journal="J Med Internet Res", year="2024", month="Dec", day="17", volume="26", pages="e63760", keywords="open-world games", keywords="cognitive escapism", keywords="relaxation", keywords="mental well-being", keywords="students", keywords="video games", keywords="stress", keywords="freedom to explore", abstract="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 ($\beta$=.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 ($\beta$=.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. ", doi="10.2196/63760", url="https://www.jmir.org/2024/1/e63760" } @Article{info:doi/10.2196/46497, author="Xian, Xuechang and Zhang, Xiaoran and Zheng, Danhe and Wang, Yanlin", title="Mental Health Benefits of Listening to Music During COVID-19 Quarantine: Cross-Sectional Study", journal="JMIR Form Res", year="2024", month="Dec", day="16", volume="8", pages="e46497", keywords="COVID-19", keywords="quarantine", keywords="social connectedness", keywords="sense of security", keywords="mental well-being", keywords="cross-sectional study", keywords="contagion", keywords="treatment", keywords="music", keywords="security", keywords="mental health", keywords="questionnaire", keywords="China", keywords="intervention", keywords="relaxation", keywords="meditation", keywords="mental illness", keywords="stimuli", keywords="environmental", abstract="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. ", doi="10.2196/46497", url="https://formative.jmir.org/2024/1/e46497" } @Article{info:doi/10.2196/65506, author="Thimmapuram, Jayaram and Patel, D. Kamlesh and Bhatt, Deepti and Chauhan, Ajay and Madhusudhan, Divya and Bhatt, K. Kashyap and Deshpande, Snehal and Budhbhatti, Urvi and Joshi, Chaitanya", title="Effect of a Web-Based Heartfulness Program on the Mental Well-Being, Biomarkers, and Gene Expression Profile of Health Care Students: Randomized Controlled Trial", journal="JMIR Bioinform Biotech", year="2024", month="Dec", day="16", volume="5", pages="e65506", keywords="heartfulness", keywords="meditation", keywords="stress", keywords="anxiety", keywords="depression", keywords="interleukins", keywords="gene expression", keywords="dehydroepiandrosterone", keywords="DHEA", keywords="gene", keywords="mental health", keywords="randomized study", keywords="web-based program", keywords="mental well-being", keywords="well-being", keywords="mental", keywords="health care students", keywords="student", keywords="mRNA", keywords="messenger ribonucleic acid", keywords="youth", keywords="young adults", keywords="web-based", keywords="biomarker", keywords="RNA", keywords="bioinformatics", keywords="randomized", keywords="statistical analysis", keywords="nursing", keywords="physiotherapy", keywords="pharmacy", abstract="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 ", doi="10.2196/65506", url="https://bioinform.jmir.org/2024/1/e65506", url="http://www.ncbi.nlm.nih.gov/pubmed/39680432" } @Article{info:doi/10.2196/63078, author="Tanaka-Kanegae, Ryohei and Yamada, Koji and Cook, M. Chad and Blonquist, M. Traci and Taggart, D. Kristen and Hamada, Koichiro", title="Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2024", month="Dec", day="10", volume="12", pages="e63078", keywords="mindfulness", keywords="guided tea meditation", keywords="meditation", keywords="matcha", keywords="green tea", keywords="mobile app", keywords="smartphone", keywords="stress", keywords="mood", keywords="mHealth", keywords="mobile health", keywords="well-being", keywords="wellness", abstract="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 ", doi="10.2196/63078", url="https://mhealth.jmir.org/2024/1/e63078" } @Article{info:doi/10.2196/55478, author="Ng, Hydra Hei-Yin and Wu, W. Changwei and Hsu, Hao-Che and Huang, Chih-Mao and Hsu, Ai-Ling and Chao, Yi-Ping and Jung, Tzyy-Ping and Chuang, Chun-Hsiang", title="Neurological Evidence of Diverse Self-Help Breathing Training With Virtual Reality and Biofeedback Assistance: Extensive Exploration Study of Electroencephalography Markers", journal="JMIR Form Res", year="2024", month="Dec", day="6", volume="8", pages="e55478", keywords="biofeedback", keywords="virtual reality", keywords="breathing training", keywords="EEG", keywords="electroencephalography", keywords="effective connectivity", abstract="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 ", doi="10.2196/55478", url="https://formative.jmir.org/2024/1/e55478" } @Article{info:doi/10.2196/45640, author="Blackmore, Rebecca and Giles, Claudia and Tremain, Hailey and Kelly, Ryan and Foley, Fiona and Fletcher, Kathryn and Nedeljkovic, Maja and Wadley, Greg and Seabrook, Elizabeth and Thomas, Neil", title="Examining the Use of Virtual Reality to Support Mindfulness Skills Practice in Mood and Anxiety Disorders: Mixed Methods Study", journal="J Med Internet Res", year="2024", month="Dec", day="6", volume="26", pages="e45640", keywords="virtual reality", keywords="mindfulness", keywords="mood disorders", keywords="anxiety disorders", keywords="depression", keywords="bipolar disorder", abstract="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. ", doi="10.2196/45640", url="https://www.jmir.org/2024/1/e45640", url="http://www.ncbi.nlm.nih.gov/pubmed/39641990" } @Article{info:doi/10.2196/66430, author="Peng, L. Mary and Monin, Joan and Ovchinnikova, Polina and Levi, Amanda and McCall, Terika", title="Psychedelic Art and Implications for Mental Health: Randomized Pilot Study", journal="JMIR Form Res", year="2024", month="Dec", day="3", volume="8", pages="e66430", keywords="digital art", keywords="mental health", keywords="psychedelic art", keywords="well-being", keywords="pilot trial", keywords="digital health tool", keywords="art therapy", abstract="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. ", doi="10.2196/66430", url="https://formative.jmir.org/2024/1/e66430" } @Article{info:doi/10.2196/60918, author="Emezue, Chuka and Dan-Irabor, Dale and Froilan, Andrew and Dunlap, Aaron and Zamora, Pablo and Negron, Sarah and Simmons, Janiya and Watkins, Jayla and Julion, A. Wrenetha and Karnik, S. Niranjan", title="Evaluating an App-Based Intervention for Preventing Firearm Violence and Substance Use in Young Black Boys and Men: Usability Evaluation Study", journal="JMIR Form Res", year="2024", month="Nov", day="26", volume="8", pages="e60918", keywords="telemedicine", keywords="mobile app", keywords="adolescent", keywords="violence", keywords="substance-related disorder", keywords="African American", keywords="user-computer interface", keywords="software validation", keywords="software development", keywords="mobile phone", abstract="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 ", doi="10.2196/60918", url="https://formative.jmir.org/2024/1/e60918", url="http://www.ncbi.nlm.nih.gov/pubmed/39589765" } @Article{info:doi/10.2196/57415, author="Malandrone, Francesca and Urru, Sara and Berchialla, Paola and Rossini, Gilbert Pierre and Oliva, Francesco and Bianchi, Silvia and Ottaviano, Manuel and Gonzalez-Martinez, Sergio and Carli, Vladimir and Valenza, Gaetano and Scilingo, Pasquale Enzo and Carletto, Sara and Ostacoli, Luca", title="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", journal="JMIR Ment Health", year="2024", month="Nov", day="21", volume="11", pages="e57415", keywords="depression", keywords="anxiety", keywords="stress", keywords="internet-based", keywords="mental health", keywords="mindfulness", keywords="breast cancer", keywords="prostate cancer", keywords="cancer-related mental distress", keywords="emotional distress", keywords="psychological distress", keywords="mindfulness-based interventions", keywords="MBI", keywords="e-MBI", keywords="dispositional mindfulness", keywords="self-compassion", keywords="mental wellbeing", keywords="mobile phone", abstract="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. ", doi="10.2196/57415", url="https://mental.jmir.org/2024/1/e57415" } @Article{info:doi/10.2196/52883, author="Wiita, Farah and Ho, K. Aileen and Weinstein, Netta", title="Web-Based Intervention Using Self-Compassionate Writing to Induce Positive Mood in Family Caregivers of Older Adults: Quantitative Study", journal="JMIR Form Res", year="2024", month="Nov", day="21", volume="8", pages="e52883", keywords="self-compassion", keywords="caregivers", keywords="mindfulness", keywords="intervention", keywords="writing", keywords="experimental", abstract="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. ", doi="10.2196/52883", url="https://formative.jmir.org/2024/1/e52883" } @Article{info:doi/10.2196/64149, author="Mace, A. Ryan and Law, E. Makenna and Cohen, E. Joshua and Ritchie, S. Christine and Okereke, I. Olivia and Hoeppner, B. Bettina and Brewer, A. Judson and Bartels, J. Stephen and Vranceanu, Ana-Maria and ", title="A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Nov", day="21", volume="13", pages="e64149", keywords="lifestyle", keywords="cognitive decline", keywords="brain health", keywords="mindfulness", keywords="mind-body therapies", keywords="telemedicine", keywords="digital health", keywords="randomized clinical trial", abstract="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 ", doi="10.2196/64149", url="https://www.researchprotocols.org/2024/1/e64149" } @Article{info:doi/10.2196/64540, author="Becker, Elizabeth Molly and Stratton Levey, Nadine and Yeh, Y. Gloria and Giacino, Joseph and Iverson, Grant and Silverberg, Noah and Parker, A. Robert and McKinnon, Ellen and Siravo, Caitlin and Shah, Priyanca and Vranceanu, Ana-Maria and Greenberg, Jonathan", title="Preliminary Feasibility of a Novel Mind-Body Program to Prevent Persistent Concussion Symptoms Among Young Adults With Anxiety: Nonrandomized Open Pilot Study", journal="JMIR Form Res", year="2024", month="Nov", day="8", volume="8", pages="e64540", keywords="concussions", keywords="mind-body", keywords="preventions", keywords="young adults", keywords="feasibility", keywords="persistence", keywords="open pilot", keywords="mind-body program", keywords="preliminary feasibility", keywords="mild traumatic brain injuries", keywords="United States", keywords="adults", keywords="psychological factors", keywords="mind-body interventions", abstract="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 ", doi="10.2196/64540", url="https://formative.jmir.org/2024/1/e64540" } @Article{info:doi/10.2196/56201, author="Yatziv, Shai-Lee and Pedrelli, Paola and Baror, Shira and DeCaro, Ann Sydney and Shachar, Noam and Sofer, Bar and Hull, Sunday and Curtiss, Joshua and Bar, Moshe", title="Facilitating Thought Progression to Reduce Depressive Symptoms: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Nov", day="7", volume="26", pages="e56201", keywords="depression", keywords="cognitive neuroscience", keywords="facilitating thought progression", keywords="FTP", keywords="mobile phone", keywords="digital health", keywords="gamification", keywords="depression symptoms", keywords="randomized controlled trial", keywords="RCT", keywords="app", keywords="depressive disorder", keywords="web-based platforms", keywords="effectiveness", abstract="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-{\AA}sberg 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; $\eta$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 ", doi="10.2196/56201", url="https://www.jmir.org/2024/1/e56201" } @Article{info:doi/10.2196/54171, author="Larson, Elizabeth and Mattie, L. Rebecca and Riffkin, A. Sophia", title="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", journal="JMIR Hum Factors", year="2024", month="Oct", day="31", volume="11", pages="e54171", keywords="autism", keywords="caregiver", keywords="activities", keywords="mindfulness", keywords="mobile application", keywords="stress", keywords="wellness", keywords="app", keywords="application", keywords="usage", keywords="children", keywords="developmental disability", keywords="usability", keywords="acceptability", keywords="meditation", keywords="wellness application", abstract="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 ", doi="10.2196/54171", url="https://humanfactors.jmir.org/2024/1/e54171" } @Article{info:doi/10.2196/56693, author="Dantes, Rasben Gede and Asril, Maylani Nice and Liem, Andrian and Suwastini, Arie Ni Komang and Keng, Shian-Ling and Mahayanti, Surya Ni Wayan", title="Brief Mobile App--Based Mindfulness Intervention for Indonesian Senior High School Teachers: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Oct", day="23", volume="13", pages="e56693", keywords="digital mental health", keywords="telemedicine", keywords="anxiety", keywords="stress", keywords="self-efficacy", keywords="life satisfaction", keywords="self-compassion", keywords="mindfulness", keywords="feasibility study", keywords="mobile app", keywords="mindfulness-based stress reduction", keywords="stress management", abstract="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 ", doi="10.2196/56693", url="https://www.researchprotocols.org/2024/1/e56693" } @Article{info:doi/10.2196/47251, author="Aubert, Morghane and Clavel, C{\'e}line and Le Scanff, Christine and Martin, Jean-Claude", title="Intervention to Improve Well-Being, Nutrition, and Physical Activity in Adults: Experimental Study", journal="JMIR Form Res", year="2024", month="Oct", day="15", volume="8", pages="e47251", keywords="mindfulness", keywords="well-being", keywords="affects", keywords="nutrition", keywords="physical activity", keywords="intervention", keywords="lifestyle habits", keywords="mindfulness exercises", abstract="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. ", doi="10.2196/47251", url="https://formative.jmir.org/2024/1/e47251", url="http://www.ncbi.nlm.nih.gov/pubmed/39405102" } @Article{info:doi/10.2196/58356, author="Travis, Aniyah and O'Donnell, Arden and Giraldo-Santiago, Natalia and Stone, M. Sarah and Torres, Daniel and Adler, R. Shelley and Vranceanu, Ana-Maria and Ritchie, S. Christine", title="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", journal="JMIR Res Protoc", year="2024", month="Oct", day="11", volume="13", pages="e58356", keywords="mindfulness", keywords="caregiver", keywords="self-compassion", keywords="ADRD", keywords="Alzheimer's disease and related dementias", keywords="mental health", abstract="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 ", doi="10.2196/58356", url="https://www.researchprotocols.org/2024/1/e58356", url="http://www.ncbi.nlm.nih.gov/pubmed/39392675" } @Article{info:doi/10.2196/49505, author="Puah, Shermain and Pua, Yee Ching and Shi, Jing and Lim, Mui Sok", title="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", journal="J Med Internet Res", year="2024", month="Oct", day="7", volume="26", pages="e49505", keywords="mental health", keywords="students", keywords="digital wellness", keywords="mobile health (mHealth)", keywords="perceived stress", keywords="self-compassion", keywords="rumination", abstract="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. ", doi="10.2196/49505", url="https://www.jmir.org/2024/1/e49505", url="http://www.ncbi.nlm.nih.gov/pubmed/39374067" } @Article{info:doi/10.2196/54817, author="Jackson, Walton Riley and Cao-Nasalga, Ann and Chieng, Amy and Pirkl, Amy and Jagielo, D. Annemarie and Xu, Cindy and Goldenhersch, Emilio and Rosencovich, Nicolas and Waitman, Cristian and Prochaska, J. Judith", title="Adding Virtual Reality Mindful Exposure Therapy to a Cancer Center's Tobacco Treatment Offerings: Feasibility and Acceptability Single-Group Pilot Study", journal="JMIR Form Res", year="2024", month="Jul", day="23", volume="8", pages="e54817", keywords="tobacco cessation", keywords="virtual reality", keywords="exposure therapy", keywords="cancer care", keywords="mobile phone", abstract="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 ", doi="10.2196/54817", url="https://formative.jmir.org/2024/1/e54817" } @Article{info:doi/10.2196/47704, author="Wang, Ting and Tang, Chulei and Jiang, Xiaoman and Guo, Yinning and Zhu, Shuqin and Xu, Qin", title="Effectiveness of Web-Based Mindfulness-Based Interventions for Patients With Cancer: Systematic Review and Meta-Analyses", journal="J Med Internet Res", year="2024", month="Jun", day="25", volume="26", pages="e47704", keywords="cancer", keywords="mindfulness-based interventions", keywords="mental health", keywords="randomized controlled trial", keywords="systematic review", keywords="meta-analysis", keywords="mindfulness", keywords="web-based intervention", keywords="oncology", keywords="delivery mode", keywords="efficacy", keywords="quality of life", keywords="program", keywords="adherence", keywords="mobile phone", abstract="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 ", doi="10.2196/47704", url="https://www.jmir.org/2024/1/e47704" } @Article{info:doi/10.2196/53966, author="Hooshmand Zaferanieh, Mohammad and Shi, Lu and Jindal, Meenu and Chen, Liwei and Zhang, Lingling and Lopes, Snehal and Jones, Karyn and Wang, Yucheng and Meggett, Kinsey and Walker, Beth Cari and Falgoust, Grace and Zinzow, Heidi", title="Web-Based Mindfulness-Based Cognitive Therapy for Adults With a History of Depression: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Jun", day="18", volume="13", pages="e53966", keywords="mindfulness-based cognitive therapy", keywords="MBCT", keywords="mindfulness-based interventions", keywords="depression", keywords="depressive symptoms", keywords="virtual delivery", keywords="mindfulness", keywords="mental health", keywords="depressive", keywords="distress", keywords="stress", keywords="remote", keywords="randomized", keywords="controlled trial", keywords="controlled trials", keywords="RCT", keywords="psychotherapy", keywords="cognitive therapy", abstract="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 ", doi="10.2196/53966", url="https://www.researchprotocols.org/2024/1/e53966", url="http://www.ncbi.nlm.nih.gov/pubmed/38888958" } @Article{info:doi/10.2196/55283, author="Kerry, Camrie and Mann, Prabhdeep and Babaei, Nazanin and Katz, Joel and Pirbaglou, Meysam and Ritvo, Paul", title="Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial", journal="JMIR Ment Health", year="2024", month="Jun", day="12", volume="11", pages="e55283", keywords="body dysmorphic disorder", keywords="BDD", keywords="dysmorphophobia", keywords="obsessive-compulsive and related disorders", keywords="OCD", keywords="internet-delivered cognitive behavior therapy", keywords="iCBT", keywords="cognitive behavior therapy", keywords="mindfulness-based cognitive therapy", keywords="mindfulness", keywords="eMental health", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/55283", url="https://mental.jmir.org/2024/1/e55283", url="http://www.ncbi.nlm.nih.gov/pubmed/38865704" } @Article{info:doi/10.2196/56616, author="Togo, Eiichi and Takami, Miki and Ishigaki, Kyoko", title="Evaluation of Autonomic Nervous System Function During Sleep by Mindful Breathing Using a Tablet Device: Randomized Controlled Trial", journal="JMIR Nursing", year="2024", month="Jun", day="12", volume="7", pages="e56616", keywords="mindfulness", keywords="sleep", keywords="cardiac potential", keywords="low frequency", keywords="high frequency", keywords="mobile phone", abstract="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 ", doi="10.2196/56616", url="https://nursing.jmir.org/2024/1/e56616", url="http://www.ncbi.nlm.nih.gov/pubmed/38865177" } @Article{info:doi/10.2196/56646, author="Chandhiruthil Sathyan, Anjana and Yadav, Pramod and Gupta, Prashant and Mahapathra, Kumar Arun and Galib, Ruknuddin", title="In Silico Approaches to Polyherbal Synergy: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2024", month="Jun", day="10", volume="13", pages="e56646", keywords="polyherbal formulation", keywords="Ayurveda system", keywords="Ayurveda", keywords="Ayurvedic medicine", keywords="Ayurvedic treatment", keywords="herbal", keywords="herbal drug", keywords="pharmacodynamic", keywords="pharmacology", keywords="computer-aided drug design", keywords="in silico methodology", keywords="scoping review", abstract="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 ", doi="10.2196/56646", url="https://www.researchprotocols.org/2024/1/e56646", url="http://www.ncbi.nlm.nih.gov/pubmed/38857494" } @Article{info:doi/10.2196/52386, author="Schl{\"a}pfer, Sonja and Schneider, Fabian and Santhanam, Prabhakaran and Eicher, Manuela and Kowatsch, Tobias and Witt, M. Claudia and Barth, J{\"u}rgen", title="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", journal="JMIR Cancer", year="2024", month="May", day="31", volume="10", pages="e52386", keywords="mobile health", keywords="mHealth", keywords="digital health", keywords="eHealth", keywords="smartphone", keywords="mobile phone", keywords="implementation", keywords="adherence", keywords="self-guided", keywords="unguided", keywords="fully automated", keywords="conversational agent", keywords="chatbot", keywords="behavior change", keywords="tailoring", keywords="self-care", keywords="cancer", keywords="app development", abstract="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. ", doi="10.2196/52386", url="https://cancer.jmir.org/2024/1/e52386", url="http://www.ncbi.nlm.nih.gov/pubmed/38819907" } @Article{info:doi/10.2196/50454, author="Schillings, Christine and Mei{\ss}ner, Echo and Erb, Benjamin and Bendig, Eileen and Schultchen, Dana and Pollatos, Olga", title="Effects of a Chatbot-Based Intervention on Stress and Health-Related Parameters in a Stressed Sample: Randomized Controlled Trial", journal="JMIR Ment Health", year="2024", month="May", day="28", volume="11", pages="e50454", keywords="chatbot", keywords="intervention", keywords="stress", keywords="interoception", keywords="interoceptive sensibility", keywords="mindfulness", keywords="emotion regulation", keywords="RCT", keywords="randomized controlled trial", abstract="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 ($\beta$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 ", doi="10.2196/50454", url="https://mental.jmir.org/2024/1/e50454", url="http://www.ncbi.nlm.nih.gov/pubmed/38805259" } @Article{info:doi/10.2196/54412, author="Zainal, Hani Nur and Newman, G. Michelle", title="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", journal="JMIR Ment Health", year="2024", month="May", day="24", volume="11", pages="e54412", keywords="empathy", keywords="theory-of-mind", keywords="mindfulness", keywords="ecological momentary intervention", keywords="generalized anxiety disorder", keywords="randomized controlled trial", keywords="mobile phone", abstract="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 ", doi="10.2196/54412", url="https://mental.jmir.org/2024/1/e54412", url="http://www.ncbi.nlm.nih.gov/pubmed/38787613" } @Article{info:doi/10.2196/53712, author="Zainal, Hani Nur and Tan, Han Hui and Hong, Shiun Ryan Yee and Newman, Gayle Michelle", title="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", journal="JMIR Ment Health", year="2024", month="Apr", day="19", volume="11", pages="e53712", keywords="social anxiety disorder", keywords="mindfulness", keywords="ecological momentary intervention", keywords="randomized controlled trial", keywords="emotion regulation", keywords="self-compassion", keywords="mechanisms of change", keywords="mobile phone", keywords="momentary interventions", keywords="self-monitoring app", keywords="regulations", keywords="participant", abstract="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 ", doi="10.2196/53712", url="https://mental.jmir.org/2024/1/e53712", url="http://www.ncbi.nlm.nih.gov/pubmed/38640015" } @Article{info:doi/10.2196/54658, author="Gagnon, M. Michelle and Brilz, R. Alexandra and Alberts, M. Nicole and Gordon, L. Jennifer and Risling, L. Tracie and Stinson, N. Jennifer", title="Understanding Adolescents' Experiences With Menstrual Pain to Inform the User-Centered Design of a Mindfulness-Based App: Mixed Methods Investigation Study", journal="JMIR Pediatr Parent", year="2024", month="Apr", day="8", volume="7", pages="e54658", keywords="adolescent health", keywords="endometriosis", keywords="pain management, biopsychosocial", keywords="women's health", keywords="dysmenorrhea", keywords="thematic analysis", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="applications", keywords="attitude", keywords="attitudes", keywords="opinion", keywords="perception", keywords="perceptions", keywords="perspective", keywords="perspectives", keywords="interest", keywords="intent", keywords="intention", keywords="survey", keywords="surveys", keywords="focus group", keywords="focus groups", keywords="content analysis", keywords="mindfulness", keywords="meditation", keywords="menstrual", keywords="menstruation", keywords="experience", keywords="experiences", keywords="pain", keywords="youth", keywords="adolescent", keywords="adolescents", keywords="teen", keywords="teens", keywords="teenager", keywords="teenagers", abstract="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. ", doi="10.2196/54658", url="https://pediatrics.jmir.org/2024/1/e54658", url="http://www.ncbi.nlm.nih.gov/pubmed/38587886" } @Article{info:doi/10.2196/55369, author="Stefana, Alberto and Vieta, Eduard and Fusar-Poli, Paolo and Youngstrom, A. Eric", title="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", journal="JMIR Res Protoc", year="2024", month="Apr", day="8", volume="13", pages="e55369", keywords="adult patients", keywords="evidence-based assessment", keywords="patient's perspective", keywords="psychotherapy", keywords="randomized controlled trial", keywords="systematic client feedback", keywords="therapeutic relationship", keywords="treatment outcome", abstract="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 ", doi="10.2196/55369", url="https://www.researchprotocols.org/2024/1/e55369", url="http://www.ncbi.nlm.nih.gov/pubmed/38587881" } @Article{info:doi/10.2196/49133, author="O'Kane, K. Kiarah M. and Otamendi, Thalia and Silverberg, D. Noah and Choi, Esther and Sicard, Veronik and Zemek, Roger and Healey, Katherine and Brown, Olivier and Butterfield, Lauren and Smith, Andra and Goldfield, Gary and Kardish, Rachel and Saab, J. Bechara and Ledoux, Andr{\'e}e-Anne and Cairncross, Molly", title="Development of Therapeutic Alliance and Social Presence in a Digital Intervention for Pediatric Concussion: Qualitative Exploratory Study", journal="JMIR Form Res", year="2024", month="Mar", day="22", volume="8", pages="e49133", keywords="adolescent", keywords="concussion", keywords="digital therapeutics", keywords="eHealth", keywords="mHealth", keywords="mindfulness", keywords="mobile health", keywords="social presence", keywords="working alliance", abstract="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. ", doi="10.2196/49133", url="https://formative.jmir.org/2024/1/e49133", url="http://www.ncbi.nlm.nih.gov/pubmed/38517472" } @Article{info:doi/10.2196/43875, author="Elliott, Mary and Khallouf, Camille and Hirsch, Jennifer and de Camps Meschino, Diane and Zamir, Orit and Ravitz, Paula", title="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", journal="JMIR Form Res", year="2024", month="Mar", day="14", volume="8", pages="e43875", keywords="COVID-19", keywords="pandemic", keywords="health care worker", keywords="resilience", keywords="mental health", keywords="burnout", keywords="well-being", keywords="mindfulness meditation", keywords="web-based group", keywords="drop-in", keywords="mindfulness", keywords="health care staff", keywords="meditation", keywords="worker", keywords="job", keywords="occupational health", abstract="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. ", doi="10.2196/43875", url="https://formative.jmir.org/2024/1/e43875", url="http://www.ncbi.nlm.nih.gov/pubmed/38180869" } @Article{info:doi/10.2196/40406, author="Gao, Yu and Shi, Lu and Fu, Ning and Yang, Nan and Weeks-Gariepy, Tracy and Mao, Yuping", title="Mobile-Delivered Mindfulness Intervention on Anxiety Level Among College Athletes: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Mar", day="8", volume="26", pages="e40406", keywords="anxiety", keywords="athletes", keywords="body", keywords="calmness", keywords="cognition", keywords="college students", keywords="college", keywords="feasibility", keywords="feedback", keywords="intervention", keywords="meditation", keywords="mHealth", keywords="mindfulness", keywords="mobile", keywords="participant", keywords="positive", keywords="program", keywords="relaxation", keywords="sleep", keywords="students", abstract="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 ($\beta$=.19; SE=.08), a lower level of ``nonjudgemental inner experience'' in FFMQ ($\beta$=--.07; SE=.03), and a lower level of ``nonreactivity'' ($\beta$=--.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 ", doi="10.2196/40406", url="https://www.jmir.org/2024/1/e40406", url="http://www.ncbi.nlm.nih.gov/pubmed/38457201" } @Article{info:doi/10.2196/54632, author="Jones, Grant and Herrmann, Felipe and Bear, Adam and Carhart-Harris, Robin and Kettner, Hannes", title="The Relationship Between Changes in Mindfulness and Subsequent Changes in Well-Being Following Psychedelic Use: Prospective Cohort Study", journal="JMIR Form Res", year="2024", month="Mar", day="4", volume="8", pages="e54632", keywords="psychedelics", keywords="mindfulness", keywords="observational", keywords="web-based survey", keywords="psychedelic", keywords="meditation", keywords="mental health", keywords="anxiety", keywords="depression", keywords="survey", keywords="surveys", keywords="drug", keywords="drugs", keywords="substance use", keywords="hallucinogen", keywords="hallucinogens", doi="10.2196/54632", url="https://formative.jmir.org/2024/1/e54632", url="http://www.ncbi.nlm.nih.gov/pubmed/38437005" } @Article{info:doi/10.2196/52338, author="Badaghi, Nasim and van Kruijsbergen, Mette and Speckens, Anne and Vil{\'e}, Jo{\"e}lle and Prins, Judith and Kelders, Saskia and Kwakkenbos, Linda", title="Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial", journal="JMIR Form Res", year="2024", month="Feb", day="21", volume="8", pages="e52338", keywords="cancer", keywords="eHeath", keywords="online interventions", keywords="mindfulness", keywords="psycho-oncology", keywords="qualitative research", keywords="oncology", keywords="CBT", keywords="blended", keywords="eMBCT", keywords="iCBT", keywords="cognitive therapy", keywords="unguided", keywords="psychotherapy", keywords="MBCT", keywords="co-creation", keywords="therapist", keywords="self-guided", keywords="peer-support", keywords="co-design", keywords="participatory", abstract="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 ", doi="10.2196/52338", url="https://formative.jmir.org/2024/1/e52338", url="http://www.ncbi.nlm.nih.gov/pubmed/38381493" } @Article{info:doi/10.2196/48557, author="Zou, Huijing and Chair, Ying Sek and Feng, Bilong and Liu, Qian and Liu, Jia Yu and Cheng, Xin Yu and Luo, Dan and Wang, Qin Xiao and Chen, Wei and Huang, Leiqing and Xianyu, Yunyan and Yang, Xiang Bing", title="A Social Media--Based Mindfulness Psycho-Behavioral Intervention (MCARE) for Patients With Acute Coronary Syndrome: Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Feb", day="20", volume="26", pages="e48557", keywords="acute coronary syndrome", keywords="psychological distress", keywords="depression", keywords="anxiety", keywords="mindfulness", keywords="mindfulness-based intervention", keywords="quality of life", keywords="risk factors", keywords="cardiac rehabilitation", keywords="social media", abstract="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: $\beta$=--2.016, 95\% CI --2.584 to --1.449, Cohen d=--1.28, P<.001; T2: $\beta$=--2.089, 95\% CI --2.777 to --1.402, Cohen d=--1.12, P<.001) and anxiety (T1: $\beta$=--1.024, 95\% CI --1.551 to --0.497, Cohen d=--0.83, P<.001; T2: $\beta$=--0.932, 95\% CI --1.519 to --0.346, Cohen d=--0.70, P=.002). Significantly greater improvements were also observed in psychological stress ($\beta$=--1.186, 95\% CI --1.678 to --0.694, Cohen d=--1.41, P<.001), physical HRQoL ($\beta$=0.088, 95\% CI 0.008-0.167, Cohen d=0.72, P=.03), emotional HRQoL ($\beta$=0.294, 95\% CI 0.169-0.419, Cohen d=0.81, P<.001), and general HRQoL ($\beta$=0.147, 95\% CI 0.070-0.224, Cohen d=1.07) at T1, as well as dietary behavior ($\beta$=0.069, 95\% CI 0.003-0.136, Cohen d=0.75, P=.04), physical activity level ($\beta$=177.542, 95\% CI --39.073 to 316.011, Cohen d=0.51, P=.01), and systolic blood pressure ($\beta$=--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 ", doi="10.2196/48557", url="https://www.jmir.org/2024/1/e48557", url="http://www.ncbi.nlm.nih.gov/pubmed/38376899" } @Article{info:doi/10.2196/54561, author="Peterson, E. Neil and Thomas, Michael and Hunsaker, Stacie and Stewart, Tevin and Collett, J. Claire", title="mHealth Gratitude Exercise Mindfulness App for Resiliency Among Neonatal Intensive Care Unit Staff: Three-Arm Pretest-Posttest Interventional Study", journal="JMIR Nursing", year="2024", month="Feb", day="16", volume="7", pages="e54561", keywords="burnout", keywords="compassion fatigue", keywords="compassion satisfaction", keywords="secondary trauma", keywords="trauma", keywords="satisfaction", keywords="compassion", keywords="gratitude", keywords="resilience", keywords="quality of life", keywords="QoL", keywords="mindfulness", keywords="meditation", keywords="exercise", keywords="happiness", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="applications", keywords="neonatal intensive care unit", keywords="NICU", keywords="intensive care unit", keywords="ICU", keywords="intensive care", keywords="nurse", keywords="nurses", keywords="nursing", keywords="health care worker", keywords="health care workers", keywords="provider", keywords="providers", keywords="phone app", keywords="physical activity", keywords="resiliency", keywords="mobile phone", abstract="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. ", doi="10.2196/54561", url="https://nursing.jmir.org/2024/1/e54561", url="http://www.ncbi.nlm.nih.gov/pubmed/38363595" } @Article{info:doi/10.2196/47745, author="Orasud, Siritorn Ariel and Uchiyama, Mai and Pagano, Ian and Bantum, Erin", title="Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Feb", day="12", volume="13", pages="e47745", keywords="cancer", keywords="cancer survivorship", keywords="mindfulness meditation", keywords="mHealth", keywords="well-being", keywords="quality of life", keywords="mobile health", keywords="coaching", keywords="coach", keywords="mindfulness", keywords="meditation", keywords="survivor", keywords="survivorship", keywords="oncology", keywords="mental health", keywords="anxiety", keywords="neuropathy", keywords="survivors", keywords="RCT", keywords="randomized", keywords="clinical trial", keywords="clinical trials", abstract="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 ", doi="10.2196/47745", url="https://www.researchprotocols.org/2024/1/e47745", url="http://www.ncbi.nlm.nih.gov/pubmed/38345843" } @Article{info:doi/10.2196/49467, author="Jaiswal, Satish and Purpura, R. Suzanna and Manchanda, K. James and Nan, Jason and Azeez, Nihal and Ramanathan, Dhakshin and Mishra, Jyoti", title="Design and Implementation of a Brief Digital Mindfulness and Compassion Training App for Health Care Professionals: Cluster Randomized Controlled Trial", journal="JMIR Ment Health", year="2024", month="Jan", day="22", volume="11", pages="e49467", keywords="compassion", keywords="digital app", keywords="digital health", keywords="digital intervention", keywords="digital mental health", keywords="digital mindfulness", keywords="EEG", keywords="health workers", keywords="healthcare professionals", keywords="mindfulness", keywords="neuroplasticity", keywords="physicians", keywords="training", abstract="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 ($\rho$=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 ($\rho$=--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 ", doi="10.2196/49467", url="https://mental.jmir.org/2024/1/e49467", url="http://www.ncbi.nlm.nih.gov/pubmed/38252479" } @Article{info:doi/10.2196/53935, author="Dover, Saunya and Ahmet, Alexandra and Bluth, Karen and Feldman, M. Brian and Goldbloom, B. Ellen and Goldfield, S. Gary and Hamilton, Sarah and Imran, Omar and Khalif, Adam and Khatchadourian, Karine and Lawrence, Sarah and Leonard, Andrew and Liu, Kuan and Ouyang, Yongdong and Peeters, Corien and Shah, Jai and Spector, Noah and Zuijdwijk, Caroline and Robinson, Marie-Eve", title="Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Dec", day="26", volume="12", pages="e53935", keywords="anxiety", keywords="depression", keywords="diabetes distress", keywords="disordered eating", keywords="mental health", keywords="mindful self-compassion", keywords="pediatrics", keywords="randomized controlled trial", keywords="type 1 diabetes", abstract="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 ", doi="10.2196/53935", url="https://www.researchprotocols.org/2023/1/e53935", url="http://www.ncbi.nlm.nih.gov/pubmed/38048480" } @Article{info:doi/10.2196/53933, author="Balsam, Donna and Bounds, T. Dawn and Rahmani, M. Amir and Nyamathi, Adeline", title="Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study", journal="JMIR Pediatr Parent", year="2023", month="Dec", day="25", volume="6", pages="e53933", keywords="mindfulness app", keywords="pregnancy", keywords="pregnant", keywords="maternal", keywords="obstetric", keywords="obstetrics", keywords="stress", keywords="anxiety", keywords="heart rate variability", keywords="mindfulness", keywords="mHealth", keywords="mobile health", keywords="app", keywords="apps", keywords="applications", keywords="mental health", keywords="meditation", keywords="mind-body", keywords="complementary", keywords="alternative", keywords="heart rate", keywords="sleep", keywords="mobile phone", abstract="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. ", doi="10.2196/53933", url="https://pediatrics.jmir.org/2023/1/e53933", url="http://www.ncbi.nlm.nih.gov/pubmed/38145479" } @Article{info:doi/10.2196/50860, author="Presciutti, Mattia Alexander and Woodworth, Emily and Rochon, Elizabeth and Neale, Molly and Motta, Melissa and Piazza, Joseph and Vranceanu, Ana-Maria and Hwang, Yi-Gin David", title="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", journal="JMIR Res Protoc", year="2023", month="Oct", day="25", volume="12", pages="e50860", keywords="severe acute brain injury", keywords="coma", keywords="caregiver", keywords="resilience", keywords="mindfulness", keywords="brain injury", keywords="emotional distress", keywords="decision-making", keywords="emotional support", keywords="intervention", keywords="support", keywords="self-report assessment", keywords="mental health", abstract="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 ", doi="10.2196/50860", url="https://www.researchprotocols.org/2023/1/e50860", url="http://www.ncbi.nlm.nih.gov/pubmed/37878376" } @Article{info:doi/10.2196/46852, author="Davis, A. Jacqueline and Ohan, L. Jeneva and Gregory, Sonia and Kottampally, Keerthi and Silva, Desiree and Prescott, L. Susan and Finlay-Jones, L. Amy", title="Perinatal Women's Perspectives of, and Engagement in, Digital Emotional Well-Being Training: Mixed Methods Study", journal="J Med Internet Res", year="2023", month="Oct", day="17", volume="25", pages="e46852", keywords="perinatal", keywords="digital mental health interventions", keywords="well-being", keywords="mindfulness", keywords="self-compassion", keywords="engagement", keywords="ORIGINS", abstract="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 ", doi="10.2196/46852", url="https://www.jmir.org/2023/1/e46852", url="http://www.ncbi.nlm.nih.gov/pubmed/37847537" } @Article{info:doi/10.2196/47371, author="Kirk, Ulrich and Staiano, Walter and Hu, Emily and Ngnoumen, Christelle and Kunkle, Sarah and Shih, Emily and Clausel, Alicia and Purvis, Clare and Lee, Lauren", title="App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2023", month="Oct", day="13", volume="11", pages="e47371", keywords="Mindfulness", keywords="mental health", keywords="stress", keywords="smartphone", keywords="technology", keywords="Headspace", keywords="mobile phone", abstract="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 ", doi="10.2196/47371", url="https://mhealth.jmir.org/2023/1/e47371", url="http://www.ncbi.nlm.nih.gov/pubmed/37831493" } @Article{info:doi/10.2196/42851, author="Min, Beomjun and Park, Heyeon and Kim, Inhyang Johanna and Lee, Sungmin and Back, Soyoung and Lee, Eunhwa and Oh, Sohee and Yun, Je-Yeon and Kim, Bung-Nyun and Kim, Yonghoon and Hwang, JungHyun and Lee, Sanghyop and Kim, Jeong-Hyun", title="The Effectiveness of a Neurofeedback-Assisted Mindfulness Training Program Using a Mobile App on Stress Reduction in Employees: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2023", month="Oct", day="3", volume="11", pages="e42851", keywords="mindfulness", keywords="neurofeedback", keywords="stress", keywords="resilience", keywords="mobile app", keywords="employee", abstract="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 $\chi$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 {\texttimes} group, Wald $\chi$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 {\texttimes} group, Wald $\chi$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 ", doi="10.2196/42851", url="https://mhealth.jmir.org/2023/1/e42851", url="http://www.ncbi.nlm.nih.gov/pubmed/37788060" } @Article{info:doi/10.2196/44220, author="Osborne, Louise Emma and Ainsworth, Ben and Hooper, Nic and Atkinson, Jayne Melissa", title="Experiences of Using Digital Mindfulness-Based Interventions: Rapid Scoping Review and Thematic Synthesis", journal="J Med Internet Res", year="2023", month="Sep", day="28", volume="25", pages="e44220", keywords="mindfulness", keywords="digital intervention", keywords="dropout", keywords="eHealth", keywords="engagement", keywords="mobile health", keywords="mHealth", keywords="psychosocial intervention", keywords="qualitative research", keywords="scoping review", keywords="thematic synthesis", keywords="mobile phone", abstract="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. ", doi="10.2196/44220", url="https://www.jmir.org/2023/1/e44220", url="http://www.ncbi.nlm.nih.gov/pubmed/37768709" } @Article{info:doi/10.2196/43358, author="Cearns, Micah and Clark, R. Scott", title="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", journal="J Med Internet Res", year="2023", month="Sep", day="19", volume="25", pages="e43358", keywords="mindfulness", keywords="meditation", keywords="digital meditation", keywords="mindfulness dose-response", keywords="meditation dose-response", keywords="dose-response", keywords="meditation adherence", keywords="mindfulness adherence", keywords="longitudinal meditation research", keywords="outcome", keywords="ecological memory assessment", keywords="mental well-being", keywords="healthy lifestyle", keywords="digital health intervention", abstract="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. ", doi="10.2196/43358", url="https://www.jmir.org/2023/1/e43358", url="http://www.ncbi.nlm.nih.gov/pubmed/37725801" } @Article{info:doi/10.2196/36808, author="Hedbom, Towe and Liljeroos, Maria and Thyl{\'e}n, Ingela and Orwelius, Lotti and Jaarsma, Tiny and Str{\"o}mberg, Anna", title="Expectations of Tele-Yoga in Persons With Long-Term Illness: Qualitative Content Analysis", journal="J Med Internet Res", year="2023", month="Sep", day="13", volume="25", pages="e36808", keywords="yoga", keywords="telerehabilitation", keywords="eHealth", keywords="chronic illness", keywords="heart failure", keywords="implantable cardioverter defibrillator", keywords="postintensive care", abstract="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 ", doi="10.2196/36808", url="https://www.jmir.org/2023/1/e36808", url="http://www.ncbi.nlm.nih.gov/pubmed/37703082" } @Article{info:doi/10.2196/47126, author="Listiyandini, Arruum Ratih and Andriani, Annisa and Kusristanti, Chandradewi and Moulds, Michelle and Mahoney, Alison and Newby, M. Jill", title="Culturally Adapting an Internet-Delivered Mindfulness Intervention for Indonesian University Students Experiencing Psychological Distress: Mixed Methods Study", journal="JMIR Form Res", year="2023", month="Aug", day="31", volume="7", pages="e47126", keywords="psychological distress", keywords="mindfulness", keywords="cultural adaptation", keywords="internet-delivered", keywords="students", keywords="Indonesia", keywords="mobile phone", abstract="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. ", doi="10.2196/47126", url="https://formative.jmir.org/2023/1/e47126", url="http://www.ncbi.nlm.nih.gov/pubmed/37651168" } @Article{info:doi/10.2196/44638, author="Schwartz, Katrin and Ganster, Marie Fabienne and Tran, S. Ulrich", title="Mindfulness-Based Mobile Apps and Their Impact on Well-Being in Nonclinical Populations: Systematic Review of Randomized Controlled Trials", journal="J Med Internet Res", year="2023", month="Aug", day="4", volume="25", pages="e44638", keywords="mindfulness", keywords="well-being", keywords="mobile app", keywords="systematic review", keywords="randomized controlled trial", keywords="RCT", keywords="mobile phone", abstract="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. ", doi="10.2196/44638", url="https://www.jmir.org/2023/1/e44638", url="http://www.ncbi.nlm.nih.gov/pubmed/37540550" } @Article{info:doi/10.2196/45027, author="Silveira, Sarita and Godara, Malvika and Singer, Tania", title="Boosting Empathy and Compassion Through Mindfulness-Based and Socioemotional Dyadic Practice: Randomized Controlled Trial With App-Delivered Trainings", journal="J Med Internet Res", year="2023", month="Jul", day="26", volume="25", pages="e45027", keywords="mental training", keywords="compassion", keywords="empathy", keywords="mindfulness", keywords="dyadic practice", keywords="acceptance", keywords="digital mental health", keywords="self-compassion", keywords="app-delivered training", keywords="Affect Dyad", keywords="mobile phone", abstract="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 ($\beta$socioemotional=.44, P<.001; $\beta$waitlist socioemotional=.30, P=.002; $\beta$mindfulness-based=.35, P<.001) and others ($\beta$socioemotional=.24, P=.003; $\beta$waitlist socioemotional=.35, P<.001; $\beta$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 ($\beta$socioemotional=.08, P=.08; $\beta$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 ($\beta$socioemotional=.17; P=.08). Empathy significantly increased in both socioemotional groups ($\beta$socioemotional=.16, P=.03; $\beta$waitlist socioemotional=.35, P<.001) and the mindfulness-based group ($\beta$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 ($\beta$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 ", doi="10.2196/45027", url="https://www.jmir.org/2023/1/e45027", url="http://www.ncbi.nlm.nih.gov/pubmed/37494106" } @Article{info:doi/10.2196/44365, author="Sommerhoff, Amanda and Ehring, Thomas and Takano, Keisuke", title="Effects of Induced Mindfulness at Night on Repetitive Negative Thinking: Ecological Momentary Assessment Study", journal="JMIR Ment Health", year="2023", month="Jul", day="19", volume="10", pages="e44365", keywords="mindfulness", keywords="repetitive negative thinking", keywords="stress", keywords="daily life", keywords="ecological momentary assessment", keywords="mobile phone", abstract="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. ", doi="10.2196/44365", url="https://mental.jmir.org/2023/1/e44365", url="http://www.ncbi.nlm.nih.gov/pubmed/37467038" } @Article{info:doi/10.2196/39158, author="Portz, Dickman Jennifer and Schmid, Arlene and Fruhauf, Christine and Fox, Aimee and Van Puymbroeck, Marieke and Sharp, Julia and Leach, Heather", title="Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study", journal="JMIR Form Res", year="2023", month="May", day="24", volume="7", pages="e39158", keywords="yoga", keywords="meditative movement", keywords="online", keywords="chronic conditions", keywords="self-management", keywords="caregiver", keywords="dyads", keywords="meditation", keywords="participation", keywords="perspective", keywords="intervention", abstract="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 ", doi="10.2196/39158", url="https://formative.jmir.org/2023/1/e39158", url="http://www.ncbi.nlm.nih.gov/pubmed/37223971" } @Article{info:doi/10.2196/44855, author="He, Ying and Tang, Zhijie and Sun, Guozhen and Cai, Cheng and Wang, Yao and Yang, Gang and Bao, ZhiPeng", title="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", journal="JMIR Mhealth Uhealth", year="2023", month="May", day="3", volume="11", pages="e44855", keywords="atrial fibrillation", keywords="radiofrequency catheter ablation", keywords="mindfulness meditation", keywords="brain computer interface", keywords="mHealth", keywords="smartphone app", keywords="randomized controlled trial", abstract="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 ", doi="10.2196/44855", url="https://mhealth.jmir.org/2023/1/e44855", url="http://www.ncbi.nlm.nih.gov/pubmed/37133926" } @Article{info:doi/10.2196/43842, author="Emezue, Chuka and Karnik, S. Niranjan and Reeder, Blaine and Schoeny, Michael and Layfield, Rickey and Zarling, Amie and Julion, Wrenetha", title="A Technology-Enhanced Intervention for Violence and Substance Use Prevention Among Young Black Men: Protocol for Adaptation and Pilot Testing", journal="JMIR Res Protoc", year="2023", month="May", day="1", volume="12", pages="e43842", keywords="youth", keywords="violence", keywords="adolescent health", keywords="mindfulness", keywords="digital health", keywords="usability", keywords="Black", keywords="African American", keywords="men", keywords="mobile app", abstract="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 ", doi="10.2196/43842", url="https://www.researchprotocols.org/2023/1/e43842", url="http://www.ncbi.nlm.nih.gov/pubmed/37126388" } @Article{info:doi/10.2196/43565, author="Lam, U. Sin and Xie, Qiang and Goldberg, B. Simon", title="Situating Meditation Apps Within the Ecosystem of Meditation Practice: Population-Based Survey Study", journal="JMIR Ment Health", year="2023", month="Apr", day="28", volume="10", pages="e43565", keywords="mindfulness", keywords="meditation", keywords="consumer behavior", keywords="user engagement", keywords="mobile health", keywords="digital health", keywords="mobile phone", abstract="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). ", doi="10.2196/43565", url="https://mental.jmir.org/2023/1/e43565", url="http://www.ncbi.nlm.nih.gov/pubmed/37115618" } @Article{info:doi/10.2196/39930, author="Stecher, Chad and Cloonan, Sara and Linnemayr, Sebastian and Huberty, Jennifer", title="Combining Behavioral Economics--Based Incentives With the Anchoring Strategy: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Apr", day="28", volume="12", pages="e39930", keywords="habits", keywords="mindfulness meditation", keywords="mobile apps", keywords="mobile health", keywords="mHealth", keywords="adherence", keywords="meditation", keywords="mindfulness", keywords="intervention", keywords="apps", keywords="smartphone apps", keywords="stress", keywords="management", keywords="mobile phone", abstract="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 ", doi="10.2196/39930", url="https://www.researchprotocols.org/2023/1/e39930", url="http://www.ncbi.nlm.nih.gov/pubmed/37115610" } @Article{info:doi/10.2196/42482, author="Berardi, Vincent and Fowers, Rylan and Rubin, Gavriella and Stecher, Chad", title="Time of Day Preferences and Daily Temporal Consistency for Predicting the Sustained Use of a Commercial Meditation App: Longitudinal Observational Study", journal="J Med Internet Res", year="2023", month="Apr", day="10", volume="25", pages="e42482", keywords="behavioral habits", keywords="habit formation", keywords="mindfulness meditation", keywords="mobile health", keywords="health app", keywords="app usage", keywords="meditation app", keywords="temporal analysis", keywords="circadian rhythm", keywords="healthy life style", keywords="physical activity", keywords="mental well being", keywords="habit", keywords="mindfulness", keywords="meditation", keywords="wellbeing", keywords="mental health", keywords="longitudinal", keywords="observational", keywords="advice", keywords="morning", abstract="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. ", doi="10.2196/42482", url="https://www.jmir.org/2023/1/e42482", url="http://www.ncbi.nlm.nih.gov/pubmed/37036755" } @Article{info:doi/10.2196/45887, author="Reilly, D. Erin and Kathawalla, Ummul-Kiram and Robins, E. Hannah and Heapy, A. Alicia and Hogan, P. Timothy and Waring, E. Molly and Quigley, S. Karen and Drebing, E. Charles and Bickmore, Timothy and Volonte, Matias and Kelly, M. Megan", title="An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Mar", day="7", volume="12", pages="e45887", keywords="chronic pain", keywords="randomized controlled trial", keywords="usability", keywords="acceptance and commitment therapy", keywords="embodied conversational agent", abstract="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 ", doi="10.2196/45887", url="https://www.researchprotocols.org/2023/1/e45887", url="http://www.ncbi.nlm.nih.gov/pubmed/36881446" } @Article{info:doi/10.2196/42861, author="Sui, Yufang and Kor, Kin Patrick Pui and Li, Mengli and Wang, Jingjing", title="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", journal="JMIR Form Res", year="2023", month="Feb", day="20", volume="7", pages="e42861", keywords="mind-body intervention", keywords="acupressure", keywords="mindfulness meditation", keywords="social media", abstract="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 ", doi="10.2196/42861", url="https://formative.jmir.org/2023/1/e42861", url="http://www.ncbi.nlm.nih.gov/pubmed/36804167" } @Article{info:doi/10.2196/41298, author="Zhang, Xuan and Li, Yang and Wang, Juan and Mao, Fangxiang and Wu, Liuliu and Huang, Yongqi and Sun, Jiwei and Cao, Fenglin", title="Effectiveness of Digital Guided Self-help Mindfulness Training During Pregnancy on Maternal Psychological Distress and Infant Neuropsychological Development: Randomized Controlled Trial", journal="J Med Internet Res", year="2023", month="Feb", day="10", volume="25", pages="e41298", keywords="digital", keywords="mobile health", keywords="mHealth", keywords="guided self-help", keywords="psychological distress", keywords="pregnancy", keywords="psychosocial intervention", keywords="mindfulness", keywords="infant", keywords="neuropsychological performance", abstract="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 ", doi="10.2196/41298", url="https://www.jmir.org/2023/1/e41298", url="http://www.ncbi.nlm.nih.gov/pubmed/36763452" } @Article{info:doi/10.2196/40135, author="Lynn, Sarah and Basso, C. Julia", title="Effects of a Neuroscience-Based Mindfulness Meditation Program on Psychological Health: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2023", month="Jan", day="19", volume="7", pages="e40135", keywords="meditation", keywords="mindfulness", keywords="mental health", keywords="compassion", keywords="self-compassion", keywords="digital", keywords="medical education", keywords="neuroscience education", keywords="depression", keywords="psychological health", keywords="mental illness", keywords="anxiety", abstract="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. ", doi="10.2196/40135", url="https://formative.jmir.org/2023/1/e40135", url="http://www.ncbi.nlm.nih.gov/pubmed/36656631" } @Article{info:doi/10.2196/39128, author="Chen, Bin and Yang, Ting and Xiao, Lei and Xu, Changxia and Zhu, Chunqin", title="Effects of Mobile Mindfulness Meditation on the Mental Health of University Students: Systematic Review and Meta-analysis", journal="J Med Internet Res", year="2023", month="Jan", day="3", volume="25", pages="e39128", keywords="digital health", keywords="mobile mindfulness meditation", keywords="mental health", keywords="university students", keywords="meta-analysis", abstract="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 ", doi="10.2196/39128", url="https://www.jmir.org/2023/1/e39128", url="http://www.ncbi.nlm.nih.gov/pubmed/36596239" } @Article{info:doi/10.2196/40139, author="Anderson, A. Molly and Budney, J. Alan and Jacobson, C. Nicholas and Nahum-Shani, Inbal and Stanger, Catherine", title="End User Participation in the Development of an Ecological Momentary Intervention to Improve Coping With Cannabis Cravings: Formative Study", journal="JMIR Form Res", year="2022", month="Dec", day="15", volume="6", number="12", pages="e40139", keywords="cannabis", keywords="formative", keywords="distraction", keywords="mindfulness", keywords="coping", keywords="youth", keywords="public health", keywords="mental health", keywords="health intervention", keywords="ecological momentary intervention", abstract="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. ", doi="10.2196/40139", url="https://formative.jmir.org/2022/12/e40139", url="http://www.ncbi.nlm.nih.gov/pubmed/36520509" } @Article{info:doi/10.2196/40360, author="Seah, L. Cassandra E. and Zhang, Zheyuan and Sun, Sijin and Wiskerke, Esther and Daniels, Sarah and Porat, Talya and Calvo, A. Rafael", title="Designing Mindfulness Conversational Agents for People With Early-Stage Dementia and Their Caregivers: Thematic Analysis of Expert and User Perspectives", journal="JMIR Aging", year="2022", month="Dec", day="6", volume="5", number="4", pages="e40360", keywords="mindfulness", keywords="dyadic", keywords="dementia", keywords="caregivers", keywords="user needs", keywords="intervention", keywords="user", keywords="feedback", keywords="design", keywords="accessibility", keywords="relationships", keywords="mindset", keywords="essential", abstract="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. ", doi="10.2196/40360", url="https://aging.jmir.org/2022/4/e40360", url="http://www.ncbi.nlm.nih.gov/pubmed/36472897" } @Article{info:doi/10.2196/39501, author="Kim, Sunghak and Park, Young Jin and Chung, Kyungmi", title="The Relationship Between the Big Five Personality Traits and the Theory of Planned Behavior in Using Mindfulness Mobile Apps: Cross-sectional Survey", journal="J Med Internet Res", year="2022", month="Nov", day="30", volume="24", number="11", pages="e39501", keywords="personality traits", keywords="Theory of Planned Behavior", keywords="mindfulness", keywords="mobile apps", keywords="mental health", abstract="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 ($\beta$=.384, P<.001), subjective norm about mindfulness ($\beta$=.249, P<.001), and perceived behavior control over mindfulness ($\beta$=.443, P<.001). Neuroticism was not correlated with attitude toward mindfulness ($\beta$=?.072, P=.28), but was correlated with subjective norm about mindfulness ($\beta$=.217, P=.003) and perceived behavior control over mindfulness ($\beta$=?.235, P<.001). Attitude toward mindfulness ($\beta$=.508, P<.001), subjective norm about mindfulness ($\beta$=.132, P=.01), and perceived behavior control over mindfulness ($\beta$=.540, P<.001) were separately correlated with behavioral intention for mindfulness. Conscientiousness was not directly correlated with behavioral intention for mindfulness ($\beta$=?.082, P=.27), whereas neuroticism was directly correlated with behavioral intention for mindfulness ($\beta$=.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. ", doi="10.2196/39501", url="https://www.jmir.org/2022/11/e39501", url="http://www.ncbi.nlm.nih.gov/pubmed/36449344" } @Article{info:doi/10.2196/40059, author="Wang, Luyao and Chen, Xing and Peng, Yueyang and Zhang, Kun and Ma, Jun and Xu, Lin and Liu, Zixuan and Liu, Li and Luo, Yang and Gu, Can", title="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", journal="J Med Internet Res", year="2022", month="Nov", day="22", volume="24", number="11", pages="e40059", keywords="mindfulness-based cancer recovery", keywords="mindfulness-based intervention", keywords="cancer-related symptom", keywords="quality of life", keywords="breast cancer", keywords="internet-delivered intervention", keywords="mobile phone", abstract="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 ", doi="10.2196/40059", url="https://www.jmir.org/2022/11/e40059", url="http://www.ncbi.nlm.nih.gov/pubmed/36413385" } @Article{info:doi/10.2196/37406, author="Yadav, Muskan and Neate, Sandra and Hassed, Craig and Chambers, Richard and Connaughton, Sherelle and Nag, Nupur", title="Mining the Gems of a Web-Based Mindfulness Intervention: Qualitative Analysis of Factors Aiding Completion and Implementation", journal="JMIR Form Res", year="2022", month="Oct", day="5", volume="6", number="10", pages="e37406", keywords="digital intervention", keywords="health education", keywords="mindfulness", keywords="online learning", keywords="behavior change", keywords="mental health", keywords="mental well-being", keywords="physical well-being", keywords="meditation", keywords="health promotion", keywords="digital health", keywords="eHealth", keywords="thematic analysis", keywords="attrition", keywords="participation", keywords="involvement", keywords="engagement", keywords="attitude", keywords="perspective", keywords="patient education", keywords="e-learning", keywords="user feedback", abstract="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. ", doi="10.2196/37406", url="https://formative.jmir.org/2022/10/e37406", url="http://www.ncbi.nlm.nih.gov/pubmed/36197709" } @Article{info:doi/10.2196/40500, author="Espel-Huynh, Hallie and Baldwin, Matthew and Puzia, Megan and Huberty, Jennifer", title="The Indirect Effects of a Mindfulness Mobile App on Productivity Through Changes in Sleep Among Retail Employees: Secondary Analysis", journal="JMIR Mhealth Uhealth", year="2022", month="Sep", day="28", volume="10", number="9", pages="e40500", keywords="mindfulness", keywords="mobile apps", keywords="workforce", keywords="workplace", keywords="sleep", keywords="presenteeism", keywords="mobile phone", abstract="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 $\alpha$ 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 ", doi="10.2196/40500", url="https://mhealth.jmir.org/2022/9/e40500", url="http://www.ncbi.nlm.nih.gov/pubmed/36169994" } @Article{info:doi/10.2196/38903, author="Huberty, L. Jennifer and Espel-Huynh, M. Hallie and Neher, L. Taylor and Puzia, E. Megan", title="Testing the Pragmatic Effectiveness of a Consumer-Based Mindfulness Mobile App in the Workplace: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2022", month="Sep", day="28", volume="10", number="9", pages="e38903", keywords="mindfulness", keywords="mobile apps", keywords="workforce", keywords="workplace", keywords="presenteeism", keywords="mental health", abstract="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 ", doi="10.2196/38903", url="https://mhealth.jmir.org/2022/9/e38903", url="http://www.ncbi.nlm.nih.gov/pubmed/36169991" } @Article{info:doi/10.2196/37823, author="Mackey, Sean and Gilam, Gadi and Darnall, Beth and Goldin, Philippe and Kong, Jiang-Ti and Law, Christine and Heirich, Marissa and Karayannis, Nicholas and Kao, Ming-Chih and Tian, Lu and Manber, Rachel and Gross, James", title="Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials", journal="JMIR Res Protoc", year="2022", month="Sep", day="27", volume="11", number="9", pages="e37823", keywords="mind-body therapies", keywords="chronic low back pain", keywords="nonpharmacologic treatments", keywords="neuroimaging", abstract="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 ", doi="10.2196/37823", url="https://www.researchprotocols.org/2022/9/e37823", url="http://www.ncbi.nlm.nih.gov/pubmed/36166279" } @Article{info:doi/10.2196/35620, author="Sylvia, G. Louisa and Lunn, R. Mitchell and Obedin-Maliver, Juno and McBurney, N. Robert and Nowell, Benjamin W. and Nosheny, L. Rachel and Mularski, A. Richard and Long, D. Millie and Merkel, A. Peter and Pletcher, J. Mark and Tovey, E. Roberta and Scalchunes, Christopher and Sutphen, Rebecca and Martin, S. Ann and Horn, J. Elizabeth and O'Boyle, Megan and Pitch, Lisa and Seid, Michael and Redline, Susan and Greenebaum, Sophie and George, Nevita and French, J. Noah and Faria, M. Caylin and Puvanich, Nicha and Rabideau, J. Dustin and Selvaggi, A. Caitlin and Yu, Chu and Faraone, V. Stephen and Venkatachalam, Shilpa and McCall, Debbe and Terry, F. Sharon and Deckersbach, Thilo and Nierenberg, A. Andrew", title="Web-Based Mindfulness-Based Interventions for Well-being: Randomized Comparative Effectiveness Trial", journal="J Med Internet Res", year="2022", month="Sep", day="12", volume="24", number="9", pages="e35620", keywords="mindfulness", keywords="well-being", keywords="web", keywords="control trial", keywords="clinical trial", keywords="cognitive therapy", keywords="intervention", keywords="mental health", keywords="mindful", keywords="eHealth", keywords="mobile phone", abstract="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 ", doi="10.2196/35620", url="https://www.jmir.org/2022/9/e35620", url="http://www.ncbi.nlm.nih.gov/pubmed/36094813" } @Article{info:doi/10.2196/31744, author="Taylor, Heather and Cavanagh, Kate and Field, P. Andy and Strauss, Clara", title="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", journal="JMIR Mhealth Uhealth", year="2022", month="Aug", day="25", volume="10", number="8", pages="e31744", keywords="self-help", keywords="mindfulness", keywords="randomized control trial", keywords="health care worker", keywords="National Health Service", keywords="NHS", keywords="doctors", keywords="nurses", keywords="stress", keywords="mental health", keywords="burnout", keywords="mobile phone", abstract="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 ($\gamma$=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 ", doi="10.2196/31744", url="https://mhealth.jmir.org/2022/8/e31744", url="http://www.ncbi.nlm.nih.gov/pubmed/36006668" } @Article{info:doi/10.2196/37195, author="Sch{\"o}nfeld, Simone and Rathmer, Ines and Michaelsen, M. Maren and Hoetger, Cosima and Onescheit, Miriam and Lange, Silke and Werdecker, Lena and Esch, Tobias", title="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", journal="JMIR Res Protoc", year="2022", month="Aug", day="2", volume="11", number="8", pages="e37195", keywords="nurses", keywords="nursing trainee", keywords="nursing student", keywords="acute care", keywords="inpatient", keywords="health promotion", keywords="mindfulness", keywords="mobile", keywords="web-based", keywords="stress", keywords="mobile phone", abstract="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 ", doi="10.2196/37195", url="https://www.researchprotocols.org/2022/8/e37195", url="http://www.ncbi.nlm.nih.gov/pubmed/35916708" } @Article{info:doi/10.2196/39007, author="Huberty, Jennifer and Bhuiyan, Nishat and Eckert, Ryan and Larkey, Linda and Petrov, Megan and Todd, Michael and Mesa, Ruben", title="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", journal="JMIR Res Protoc", year="2022", month="Jul", day="1", volume="11", number="7", pages="e39007", keywords="hematological cancers", keywords="mobile health", keywords="mHealth", keywords="meditation", keywords="sleep disturbance", keywords="mobile phone", abstract="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-$\alpha$, 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 ", doi="10.2196/39007", url="https://www.researchprotocols.org/2022/7/e39007", url="http://www.ncbi.nlm.nih.gov/pubmed/35776489" } @Article{info:doi/10.2196/34995, author="Gomaa, Sameh and West, Carly and Lopez, Maria Ana and Zhan, Tingting and Schnoll, Max and Abu-Khalaf, Maysa and Newberg, Andrew and Wen, Kuang-Yi", title="A Telehealth-Delivered Tai Chi Intervention (TaiChi4Joint) for Managing Aromatase Inhibitor--Induced Arthralgia in Patients With Breast Cancer During COVID-19: Longitudinal Pilot Study", journal="JMIR Form Res", year="2022", month="Jun", day="21", volume="6", number="6", pages="e34995", keywords="breast cancer", keywords="arthralgia", keywords="tai chi", keywords="telehealth, pain", keywords="mind-body therapy", abstract="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 ", doi="10.2196/34995", url="https://formative.jmir.org/2022/6/e34995", url="http://www.ncbi.nlm.nih.gov/pubmed/35727609" } @Article{info:doi/10.2196/36012, author="Sado, Mitsuhiro and Yamada, Masashi and Ninomiya, Akira and Nagaoka, Maki and Goto, Naho and Koreki, Akihiro and Nakagawa, Atsuo and Segal, Zindel and Mimura, Masaru", title="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", journal="JMIR Res Protoc", year="2022", month="Jun", day="13", volume="11", number="6", pages="e36012", keywords="mindfulness-based cognitive therapy", keywords="mindfulness", keywords="cognitive therapy", keywords="occupational health", keywords="workplace", keywords="randomized controlled trial", keywords="cost-effectiveness", keywords="cost", keywords="online", keywords="internet-based", keywords="eHealth", keywords="mental health", keywords="heath outcome", keywords="work", keywords="stress", keywords="burnout", keywords="productivity", keywords="employee", abstract="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 ", doi="10.2196/36012", url="https://www.researchprotocols.org/2022/6/e36012", url="http://www.ncbi.nlm.nih.gov/pubmed/35387762" } @Article{info:doi/10.2196/34651, author="Reynolds, Allie and Hamidian Jahromi, Alireza", title="Improving Postoperative Care Through Mindfulness-Based and Isometric Exercise Training Interventions: Systematic Review", journal="JMIR Perioper Med", year="2022", month="Jun", day="10", volume="5", number="1", pages="e34651", keywords="postoperative care", keywords="mindfulness", keywords="isometric exercise", keywords="mindfulness-based interventions", keywords="meditation", keywords="cognitive therapy", keywords="improving care", keywords="postoperative", keywords="systematic review", abstract="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. ", doi="10.2196/34651", url="https://periop.jmir.org/2022/1/e34651", url="http://www.ncbi.nlm.nih.gov/pubmed/35687415" } @Article{info:doi/10.2196/34951, author="Pace, W. Thaddeus W. and Zeiders, H. Katharine and Cook, H. Stephanie and Sarsar, D. Evelyn and Hoyt, T. Lindsay and Mirin, L. Nicholas and Wood, P. Erica and Tatar, Raquel and Davidson, J. Richard", title="Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Meditation Intervention to Decrease Firefighter Psychological Distress and Burnout: A One-Group Pilot Study", journal="JMIR Form Res", year="2022", month="Jun", day="8", volume="6", number="6", pages="e34951", keywords="firefighter", keywords="meditation", keywords="smartphone app", keywords="anxiety", keywords="cortisol", keywords="digital health", keywords="mobile health", keywords="mHealth", keywords="mental health", keywords="burnout", keywords="stress management", abstract="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. ", doi="10.2196/34951", url="https://formative.jmir.org/2022/6/e34951", url="http://www.ncbi.nlm.nih.gov/pubmed/35675115" } @Article{info:doi/10.2196/29092, author="James-Palmer, Aurora and Anderson, Zambo Ellen and Daneault, Jean-Francois", title="Remote Delivery of Yoga Interventions Through Technology: Scoping Review", journal="J Med Internet Res", year="2022", month="Jun", day="6", volume="24", number="6", pages="e29092", keywords="complementary therapies", keywords="mind-body", keywords="remote delivery", keywords="telerehabilitation", keywords="eHealth", keywords="yoga", keywords="technology", abstract="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. ", doi="10.2196/29092", url="https://www.jmir.org/2022/6/e29092", url="http://www.ncbi.nlm.nih.gov/pubmed/35666562" } @Article{info:doi/10.2196/30294, author="Laird, Breanne and Puzia, Megan and Larkey, Linda and Ehlers, Diane and Huberty, Jennifer", title="A Mobile App for Stress Management in Middle-Aged Men and Women (Calm): Feasibility Randomized Controlled Trial", journal="JMIR Form Res", year="2022", month="May", day="24", volume="6", number="5", pages="e30294", keywords="stress", keywords="meditation", keywords="mHealth", keywords="COVID-19", keywords="mobile app", keywords="mental health", keywords="mindfulness", keywords="digital intervention", keywords="psychological outcomes", abstract="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 ", doi="10.2196/30294", url="https://formative.jmir.org/2022/5/e30294", url="http://www.ncbi.nlm.nih.gov/pubmed/34989677" } @Article{info:doi/10.2196/37876, author="Thimmapuram, Jayaram and Patel, Kamlesh and Madhusudhan, K. Divya and Deshpande, Snehal and Bouderlique, Ekta and Nicolai, Veronique and Rao, Raghavendra", title="Health-Related Quality of Life Outcomes With Regular Yoga and Heartfulness Meditation Practice: Results From a Multinational, Cross-sectional Study", journal="JMIR Form Res", year="2022", month="May", day="17", volume="6", number="5", pages="e37876", keywords="yoga", keywords="meditation", keywords="health-related quality of life", keywords="Heartfulness", keywords="COVID-19", keywords="healthy living", keywords="wellness", keywords="quality of life", keywords="stress", keywords="mental health", keywords="psychological health", keywords="online survey", keywords="cross-sectional study", keywords="health outcome", abstract="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 $\chi$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. ", doi="10.2196/37876", url="https://formative.jmir.org/2022/5/e37876", url="http://www.ncbi.nlm.nih.gov/pubmed/35470800" } @Article{info:doi/10.2196/29227, author="Gardiner, Paula and McGonigal, Lisa and Villa, Ariel and Kovell, C. Lara and Rohela, Pallavi and Cauley, Andrew and Rinker, Diana and Olendzki, Barbara", title="Our Whole Lives for Hypertension and Cardiac Risk Factors---Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial", journal="JMIR Form Res", year="2022", month="May", day="16", volume="6", number="5", pages="e29227", keywords="hypertension", keywords="health disparities", keywords="teaching kitchen", keywords="technology", keywords="mindfulness", keywords="low income", keywords="medical group visits", keywords="mobile phone", abstract="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