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

NCT04594616 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-26

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594616 on ClinicalTrials.gov