Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.
Study Overview
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 QIDS-C 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.
Time Frame: Endpoint (week 8)
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).
Secondary Outcomes
- Difference in quality of life at the end of treatment/waitlist period(Endpoint (week 8))
- Difference in functional impairment at the end of treatment/waitlist period(Endpoint (week 8))
Investigators
Sabine Wilhelm, PhD
Chief of Psychology
Massachusetts General Hospital