Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder
• Interventions: Device: Smartphone-delivered CBT for MDD

• Registration Number: NCT04594616
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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 SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

Detailed Description

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).

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Study Start: 2024-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• At least 18 years of age
• Current diagnosis of primary DSM-5 MDD, based on MINI
• Currently living in the United States

Exclusion Criteria

• Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
• Past participation in ≥ 4 sessions of CBT for depression
• Current severe substance use disorder
• Lifetime bipolar disorder or psychosis
• Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
• Concurrent psychological treatment
• Does not own a supported mobile Smartphone with a data plan
• Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 Week Waitlist Control	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).
Smartphone-delivered CBT for MDD	Smartphone-delivered CBT for MDD	8-week Smartphone delivered CBT for MDD.

Primary Outcome Measures

Name	Time	Method
Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.	Endpoint (week 8)	The Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) 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). \*\*\*\* EDIT

Secondary Outcome Measures

Name	Time	Method
Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF	Endpoint (week 8)	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).
Difference in functional impairment at the end of treatment/waitlist period	Endpoint (week 8)	Participants who receive app-CBT will have greater improvement on functional impairment (WSAS). The WSAS uses a Likert scale from 0 (not impaired at all) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States