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Negative symptoms are an important unmet treatment need for schizophrenia. This study is a preliminary, open, single-arm trial of a novel hybrid intervention called mobile-assisted cognitive behavioral therapy for negative symptoms (mCBTn).
The primary aim was to test whether mCBTn was feasible and could reduce severity of the target mechanism, defeatist performance attitudes, which are associated with experiential negative symptoms and poor functioning in schizophrenia.
Participants with schizophrenia or schizoaffective disorder (N=31) who met prospective criteria for persistent negative symptoms were enrolled. The blended intervention combines weekly in-person group therapy with a smartphone app called CBT2go. The app extended therapy group skills, including recovery goal setting, thought challenging, scheduling of pleasurable activities and social interactions, and pleasure-savoring interventions to modify defeatist attitudes and improve experiential negative symptoms.
Retention was excellent (87% at 18 weeks), and severity of defeatist attitudes and experiential negative symptoms declined significantly in the mCBTn intervention with large effect sizes.
The findings suggest that mCBTn is a feasible and potentially effective treatment for experiential negative symptoms, if confirmed in a larger randomized controlled trial. The findings also provide support for the defeatist attitude model of experiential negative symptoms and suggest that blended technology-supported interventions such as mCBTn can strengthen and shorten intensive psychosocial interventions for schizophrenia.
ClinicalTrials.gov NCT03179696; https://clinicaltrials.gov/ct2/show/NCT03179696
Negative symptoms account for much of the poor functional outcome in schizophrenia and are an unmet treatment need [
Beck and colleagues [
Defeatist attitudes can be targeted in cognitive behavioral therapy (CBT). Clinical trials of CBT for psychosis have found mixed results for reducing negative symptoms [
Smartphones are widely available, affordable, and frequently used by individuals with serious mental illness [
Given the promise of in-person and mobile CBT interventions targeting defeatist attitudes and motivation in schizophrenia, we developed a blended intervention, called mobile-assisted cognitive behavioral therapy for negative symptoms (mCBTn), which combines in-person, 90-minute, weekly groups with a mobile app called CBT2go. The mCBTn intervention primarily targets defeatist attitudes to improve experiential negative symptoms in schizophrenia. The CBT components and skills-training approach of our CBSST group intervention were combined with mobile thought-challenging interventions that were based on our Mobile Assessment and Treatment of Schizophrenia (MATS) [
We conducted an open preliminary trial of mCBTn in patients with schizophrenia or schizoaffective disorder with moderate to severe persistent negative symptoms, and hypothesized that defeatist attitudes and experiential negative symptoms would be significantly reduced from baseline to end of treatment. This open trial was funded as part of the National Institute of Mental Health Experimental Therapeutics Program (RFA-MH-18-704 R61/R33), which involves preliminary testing of an intervention's impact on a target mechanism (ie, defeatist attitudes) associated with an important clinical outcome (ie, experiential negative symptoms). The primary aim of the study was target engagement; that is, we hypothesized that mCBTn would lead to a significant reduction in severity of defeatist attitudes. We also assessed participants at 12, 18, and 24 weeks of treatment to determine which dose of treatment could produce at least a medium effect size (Cohen
This was a single-arm, open-trial, pre-post evaluation of the feasibility and preliminary effect of mCBTn. This trial was registered at ClinicalTrials.gov (NCT03179696).
The study protocol was reviewed and approved by the Institutional Review Board of the University of California, San Diego, prior to initiating research activities with participants. Participants with schizophrenia or schizoaffective disorder were selected who have moderate to severe persistent experiential negative symptoms [
Voluntary informed consent to participate and capacity to consent.
Aged 18-65 years.
Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnosis of schizophrenia or schizoaffective disorder based on a Structured Clinical Interview for DSM-5 (SCID-5) interview and available medical record review.
Moderate to severe experiential negative symptoms in at least two of the three Clinical Assessment Interview for Negative Symptoms [
Moderate to severe defeatist attitudes (score of >50 on the Defeatist Performance Attitude Scale [DPAS] [
A 6th grade or higher reading level on the Wide Range Achievement Test-4 Reading subtest.
Clinically stable and on stable medications (ie, no hospitalizations or medication changes in 4 months prior to enrollment).
Exclusion criteria were as follows:
Prior CBT in the past 2 years.
Greater than moderate Positive and Negative Syndrome Scale (PANSS) [
Severe depression on the Calgary Depression Scale for Schizophrenia (CDS) [
Extrapyramidal symptoms: Simpson-Angus Scale [
DSM-5 alcohol or substance use disorder in past 3 months based on the SCID-5.
Level of care required interferes with outpatient therapy (eg, hospitalized or severe medical illness).
Unable to adequately see or manually manipulate the mobile device.
The therapy group and the mobile app integrated skills-based interventions, including recovery goal setting, thought challenging, scheduling of pleasurable activities and social interactions, and pleasure-savoring interventions to modify defeatist attitudes and improve motivation and pleasure negative symptoms. A modified 12-session version of the Cognitive Skills Module of CBSST [
The mCBTn manual included a therapist guide and a patient workbook describing the skills and homework assignments, as well as a collection of games and exercises to make learning fun and promote engagement [
An iPhone 5s or 5SE was provided to all participants with an unlimited data plan and could receive and send unlimited texts and phone calls. Mobile interactions were triggered by an app notification in the morning, with reminder prompts at midday and evening. If participants responded to the notification earlier in the day, the second and/or third notifications were not delivered. The purpose of the notifications was to prompt daily engagement with the app. Device training was provided on how to operate and charge the device, the meaning of all questions and response choices, procedures for carrying the device, responding to prompts, how to access crisis lines, and how to use various apps. This information was also provided in a written manual given to participants. Participants returned the device at the end of treatment.
The CBT2go app was used to prompt and track each group member’s goal-directed activities in the community, facilitate adherence to homework assignments involving community practice of thought-challenging skills trained in group, and prompt performance and savoring of personalized pleasurable activities and social interactions planned in group. The CBT2go app used personalized statements developed in group to challenge social disinterest and defeatist attitudes in real-time, real-world environments. After groups, therapists could enter personalized comments that participants made in group into a web-based dashboard (eg, “Having coffee with Jim is fun” and “Angie always makes you laugh”), which were used by the app to challenge low expectation ratings of motivation, anticipatory pleasure, or anticipated success for planned activities (see sample screenshots in
Participants carried the device and received the mobile intervention for the entire 24-week, blended group-plus-app intervention period. Each day during treatment, the CBT2go app alerted participants in the morning to make an
Finally, an on-demand recovery goal–setting component of the CBT2go app was also provided and was populated during the goal-setting sessions in group by therapists and participants, as well as between sessions for homework by participants. A long-term goal was set and short-term goals and goal steps that would facilitate achievement of the long-term goal were entered into the app. The app could be accessed on demand to remind participants of goals, and goal steps could be checked off to track and motivate goal progress.
Screenshots of the CBT2go app for planning pleasurable or social activity. Low motivation, high defeatist attitudes (ie, anticipated success), or low anticipatory pleasure ratings triggered personalized reappraisal evidence. A separate My Activities tool was used to plan and savor activities.
Participants were assessed at 2 weeks prior to baseline; at baseline; and at 12, 18, and 24 weeks of treatment. Dysfunctional attitudes were measured on the DPAS [
Mixed-effects regression models, utilizing HLM (hierarchical linear modeling) v6.08 (Scientific Software International), were estimated to predict each in-lab outcome assessment and mobile CBT2go app ratings of motivation, success, and anticipated pleasure for activities using time in weeks since baseline as a level-1 predictor. Paired-sample, 2-tailed
We recruited and assessed 67 participants; see the CONSORT (Consolidated Standards of Reporting Trials) diagram in
CONSORT (Consolidated Standards of Reporting Trials) flow diagram of participants through the open trial. CBT: cognitive behavioral therapy; DPAS: Defeatist Performance Attitude Scale.
Outcome variables and paired
Outcome measure and time points | n (%) | Score, mean (SD) | Cohen |
2-tailed |
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Baseline | 31 (100) | 66.3 (14.4) | N/Ab | N/A | N/A |
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12 Weeks | 28 (90) | 60.7 (15.9) | 0.40 | 2.23 (27) | .03 |
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18 Weeks | 27 (87) | 56.4 (15.7) | 0.70 | 4.02 (26) | <.001 |
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24 Weeks | 25 (81) | 52.2 (17.3) | 1.00 | 4.10 (24) | <.001 |
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Baseline | 30 (100) | 5.9 (3.1) | N/A | N/A | N/A |
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12 Weeks | 28 (93) | 6.5 (2.9) | –0.20 | 0.58 (27) | .57 |
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18 Weeks | 27 (90) | 6.2 (3.2) | –0.10 | 0.21 (26) | .84 |
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24 Weeks | 25 (83) | 6.4 (3.3) | –0.15 | 0.19 (24) | .85 |
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Baseline | 31 (100) | 23.1 (3.4) | N/A | N/A | N/A |
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12 Weeks | 28 (90) | 21.3 (6.1) | 0.55 | 2.07 (27) | .048 |
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18 Weeks | 27 (87) | 20.5 (6.2) | 0.75 | 2.95 (26) | .007 |
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24 Weeks | 25 (81) | 20.0 (6.8) | 0.90 | 3.16 (24) | .004 |
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Baseline | 31 (100) | 4.9 (3.2) | N/A | N/A | N/A |
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12 Weeks | 28 (90) | 4.7 (3.6) | 0.05 | 0.56 (27) | .58 |
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18 Weeks | 27 (87) | 4.3 (3.3) | 0.20 | 1.18 (26) | .25 |
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24 Weeks | 25 (81) | 4.4 (3.3) | 0.15 | 1.11 (24) | .28 |
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Baseline | 31 (100) | 13.4 (4.5) | N/A | N/A | N/A |
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12 Weeks | 28 (90) | 13.0 (4.3) | 0.10 | 0.75 (27) | .46 |
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18 Weeks | 26 (84) | 12.8 (4.8) | 0.10 | 0.64 (25) | .52 |
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24 Weeks | 24 (77) | 11.5 (4.0) | 0.45 | 2.46 (23) | .02 |
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Baseline | 31 (100) | 3.4 (2.2) | N/A | N/A | N/A |
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12 Weeks | 28 (90) | 3.4 (2.6) | 0 | 0 (27) | >.99 |
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18 Weeks | 27 (87) | 3.1 (2.5) | 0.10 | 0.85 (26) | .40 |
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24 Weeks | 25 (81) | 2.7 (2.5) | 0.30 | 1.99 (24) | .06 |
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Baseline | 31 (100) | 23.3 (6.1) | N/A | N/A | N/A |
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12 Weeks | 28 (90) | 25.8 (7.9) | 0.40 | 2.17 (27) | .04 |
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18 Weeks | 27 (87) | 24.9 (8.3) | 0.25 | 1.78 (26) | .09 |
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24 Weeks | 25 (81) | 24.8 (8.8) | 0.25 | 1.77 (24) | .09 |
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Baseline | 31 (100) | 114.7 (21.8) | N/A | N/A | N/A |
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12 Weeks | 27 (87) | 118.5 (22.2) | 0.15 | 2.27 (26) | .03 |
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18 Weeks | 27 (87) | 115.9 (23.6) | 0.05 | 1.70 (26) | .10 |
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24 Weeks | 25 (81) | 117.3 (26.7) | 0.10 | 1.70 (24) | .10 |
aA positive Cohen
bN/A: not applicable.
The effect of time was significant for defeatist performance attitudes (DPAS: γ=–0.59,
Significant reduction in severity of experiential negative symptoms was found (CAINS-MAP: γ=–0.14,
CBT2go app ratings of motivation and anticipated pleasure and success for completing planned activities increased significantly for motivation (γ=0.007,
Significant improvement in A-QLS scores was found between baseline and 12 weeks but not at other assessment points, and the effect of time was not significant (γ=0.08,
The CBT2go app prompted participants to select an action plan each day during up to 168 days of treatment. There was a mean of 18.7 (SD 21.3) responses to 84 action plan prompts (22%) at 12 weeks and a mean of 32.3 (SD 31.5) responses to 168 action plan prompts (19.2%) at 24 weeks for participants who did not drop out of treatment by each assessment point; this indicates engagement in homework and skills practice more than once per week, with minimal fatigue effects over the course of treatment. The number of action plans completed was not significantly correlated with any symptom measure at baseline (range of
In HLM analyses examining the association between app engagement and outcome, the number of action plans by time interaction was significant for change in CAINS-MAP scores (γ=–0.003,
The results of this open trial of mCBTn showed significant, large, within-group improvements in defeatist attitudes and negative symptoms and defeatist attitudes by 18 weeks of treatment, which demonstrates feasibility and engagement of the defeatist attitudes target, and justifies a larger RCT. These findings also provide support for the defeatist attitude model of negative symptoms [
This study adds to the growing literature on CBT-based mobile interventions for schizophrenia [
Related to this, recent meta-analyses have suggested that SST may be a more effective treatment for negative symptoms of schizophrenia than CBT [
With regard to secondary outcomes, modest improvements were found in positive symptoms and depression with a longer 24-week treatment period, which was not expected, given that participants were screened for severe positive symptoms and depression. Changes in functioning were mixed, with significant improvements found early in treatment but then dissipated with only trend-level improvements found overall on the A-QLS and SFS. The 24-week follow-up period may be too brief to expect meaningful changes in functioning.
This study had a high exclusion rate during the run-in period, with 36 out of 67 (54%) participants not meeting the strict, persistent, negative symptom entry criteria. A high screen failure rate during run-in periods is common in clinical trials with similar persistent negative symptom criteria. For example, a screen failure rate of 44% was found in a psychosocial trial using similar criteria, except DPAS [
Retention rates were excellent (81%-90% across assessments), especially for this negative symptom population, suggesting the intervention is feasible. It may be important that transportation was provided to therapy groups, which likely facilitated retention and may be necessary to maintain engagement of this population, especially in a large county with limited public transportation where this study was conducted. We have found much better retention in CBSST trials when transportation was provided [
Engagement with the CBT2go app was mixed. The app was designed to promote engagement in recovery activities as often as every day. On average, however, participants responded to prompts to make an action plan for the day about one and a half times per week. While this proportion of days with completed action plans may seem low, practicing skills and completing homework assignments more than once per week is greater homework adherence than would be expected with CBT group therapy alone, where participants are typically expected to complete a single homework assignment per week. Homework adherence in CBT psychosocial interventions across multiple disorders is approximately 20%-56%. Thus, completing approximately one and a half action plans per week is better community engagement in recovery activities than might be expected in CBT therapy alone with one assignment per week. Greater engagement with the app was also associated with greater improvement in motivational negative symptoms and was unrelated to baseline severity of negative symptoms, suggesting the app played an important role in strengthening the treatment’s impact on this important outcome.
This trial had several limitations. First, as described above, further app development is needed to promote engagement (eg, simplified interface and rewards and feedback to motivate). In addition, patients with greater severity of defeatist attitudes were recruited, because this was the target mechanism, so the findings may not generalize to patients whose experiential negative symptoms may not be related to defeatist attitudes. Participants were also excluded for severe positive symptoms or depression, so findings may not generalize to these populations. Finally, and importantly, this was a preliminary open trial that did not control for the effects of time, therapist contact, trips out of the home to come to group, socialization with staff and other patients, and other nonspecific factors. The next step is to complete an RCT with a contact control condition, which we are currently conducting. If this ongoing RCT with the modified CBT2go app confirms the findings of this open trial, this would provide stronger support for the defeatist attitude model of experiential negative symptoms and suggest that blended interventions like mCBTn can strengthen and shorten intensive psychosocial interventions for negative symptoms in schizophrenia.
Asocial Beliefs Scale
Abbreviated Quality of Life Scale
Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure
cognitive behavioral social skills training
cognitive behavioral therapy
Calgary Depression Scale for Schizophrenia
Consolidated Standards of Reporting Trials
Defeatist Performance Attitude Scale
Diagnostic and Statistical Manual of Mental Disorders, fifth edition
ecological momentary assessment
hierarchical linear modeling
Mobile Assessment and Treatment of Schizophrenia
mobile-assisted cognitive behavioral therapy for negative symptoms
Positive and Negative Syndrome Scale
Personalized Real-time Intervention for Motivational Enhancement
randomized controlled trial
Smartphone-Assisted coping-focused interVention for Voices
Structured Clinical Interview for DSM-5
Social Functioning Scale
social skills training
We thank the participants who volunteered for this study. Research reported in this publication was supported by the National Institute of Mental Health (principal investigator EG; R61MH110019). This open trial was funded as part of the National Institute of Mental Health Experimental Therapeutics Program (RFA-MH-18-704 R61/R33). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Veterans Affairs or National Institutes of Health.
EG has an equity interest in Granholm Consulting, Inc, and may benefit from the research results as he receives income from the company for CBSST workshops and consulting. The terms of this arrangement have been reviewed and approved by the University of California, San Diego, in accordance with its conflict of interest policies. All other authors have no conflicts of interest to declare.