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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04594616
Other study ID # 2018P001670
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date December 1, 2027

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Emma Wolfe, BA
Phone 617-726-6531
Email ewolfe1@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date December 1, 2027
Est. primary completion date September 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Koa Health B.V.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period. 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 Endpoint (week 8)
Secondary Difference in functional impairment at the end of treatment/waitlist period 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. Endpoint (week 8)
Secondary Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF 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). Endpoint (week 8)
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