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

Major Depressive Disorder Clinical Trial

Official title:

Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04594616
• Other study ID #: 2018P001670
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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)