Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-22 @ 11:08 AM
Study NCT ID:
NCT03769350
Status:
WITHDRAWN
Last Update Posted:
2025-06-04
First Post:
2018-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD), Withdrawn
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial
Status:
WITHDRAWN
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study must be registered under the sponsor instead of the site, so we have created a new posting in the sponsor's account.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: