A Randomized Controlled Trial in Routine Clinical Practice Comparing Acceptance and Commitment Therapy with Cognitive Behavioral Therapy for the Treatment of Major Depressive Disorder

Background Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. Objective This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. Methods This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. Results The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. Conclusions The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. Trial Registration ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728 International Registered Report Identifier (IRRID) PRR1-10.2196/14309

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Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.14309 ◽

2019 ◽

Author(s):

Mojtaba Yekrang Safakar ◽

Marianne Hrabok ◽

Liana Urichuk ◽

Michal Juhas ◽

Reham Shalaby ◽

...

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Major Depressive Disorder ◽

Depressive Disorder ◽

Behavioral Therapy ◽

Controlled Trial ◽

Major Depressive ◽

Randomized Controlled ◽

To Receive ◽

Group Cbt

BACKGROUND Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. OBJECTIVE This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. METHODS This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. RESULTS The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. CONCLUSIONS The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. CLINICALTRIAL ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14309

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Exploring the Effects of In-App Components on Engagement With a Symptom-Tracking Platform Among Participants With Major Depressive Disorder (RADAR-Engage): Protocol for a 2-Armed Randomized Controlled Trial (Preprint)

10.2196/preprints.32653 ◽

2021 ◽

Author(s):

Katie M White ◽

Faith Matcham ◽

Daniel Leightley ◽

Ewan Carr ◽

Pauline Conde ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Major Depressive Disorder ◽

Clinical Practice ◽

Data Collection ◽

Depressive Disorder ◽

Controlled Trial ◽

Remote Measurement ◽

Major Depressive ◽

Randomized Controlled ◽

Depression Status

BACKGROUND Multi-parametric remote measurement technologies (RMTs) comprise smartphone apps and wearable devices for both active and passive symptom tracking. They hold potential for understanding current depression status and predicting future depression status. However, the promise of using RMTs for relapse prediction is heavily dependent on user engagement, which is defined as both a behavioral and experiential construct. A better understanding of how to promote engagement in RMT research through various in-app components will aid in providing scalable solutions for future remote research, higher quality results, and applications for implementation in clinical practice. OBJECTIVE The aim of this study is to provide the rationale and protocol for a 2-armed randomized controlled trial to investigate the effect of insightful notifications, progress visualization, and researcher contact details on behavioral and experiential engagement with a multi-parametric mobile health data collection platform, Remote Assessment of Disease and Relapse (RADAR)–base. METHODS We aim to recruit 140 participants upon completion of their participation in the RADAR Major Depressive Disorder study in the London site. Data will be collected using 3 weekly tasks through an active smartphone app, a passive (background) data collection app, and a Fitbit device. Participants will be randomly allocated at a 1:1 ratio to receive either an adapted version of the active app that incorporates insightful notifications, progress visualization, and access to researcher contact details or the active app as usual. Statistical tests will be used to assess the hypotheses that participants using the adapted app will complete a higher percentage of weekly tasks (behavioral engagement: primary outcome) and score higher on self-awareness measures (experiential engagement). RESULTS Recruitment commenced in April 2021. Data collection was completed in September 2021. The results of this study will be communicated via publication in 2022. CONCLUSIONS This study aims to understand how best to promote engagement with RMTs in depression research. The findings will help determine the most effective techniques for implementation in both future rounds of the RADAR Major Depressive Disorder study and, in the long term, clinical practice. CLINICALTRIAL ClinicalTrials.gov NCT04972474; http://clinicaltrials.gov/ct2/show/NCT04972474 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/32653

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