Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD), Withdrawn

Mass General Brigham

Status: Withdrawn

Conditions: Major Depressive Disorder

Treatments: Device: Smartphone-delivered CBT for MDD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03769350

2018P001670-A

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Smartphone-delivered CBT for MDD

Experimental group

Description:

8-week Smartphone delivered CBT for MDD.

Treatment:

Device: Smartphone-delivered CBT for MDD

8 Week Waitlist Control

Other group

Description:

8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).

Treatment:

Device: Smartphone-delivered CBT for MDD