NCT04594616

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2020-10-20
• Last updated: 2025-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study