Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)
NCT04594616 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-05-26
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).
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Koa Health B.V.
collaborator INDUSTRY -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Sabine Wilhelm, PhD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2027-09-01
- Completion
- 2027-12-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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