An interventional study of Smartphone-delivered CBT for MDD in Major Depressive Disorder, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in QIDS-C scores than those in the waitlist condition at treatment endpoint (week 8).
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).
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Exclusion Criteria:
8-week Smartphone delivered CBT for MDD.
Device: Smartphone-delivered CBT for MDD
8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).
Device: Smartphone-delivered CBT for MDD
8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.
Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.
The Quick Inventory of Depressive Symptomatology- Clinician version (QIDS-C) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27).
Time frame: Endpoint (week 8)
Difference in functional impairment at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
Time frame: Endpoint (week 8)
Difference in quality of life at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Time frame: Endpoint (week 8)
This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital