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

NCT04594616 | Withdrawn DMC FDA Device

• 1 other identifier: 2018P001670
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.

  The Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) 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). \*\*\*\* EDIT

  Endpoint (week 8)

Secondary Outcomes (2)

• Difference in functional impairment at the end of treatment/waitlist period

  Endpoint (week 8)

• Difference in quality of life at the end of treatment/waitlist period: Q-LES-Q-SF

  Endpoint (week 8)

Study Arms (2)

Smartphone-delivered CBT for MDD

EXPERIMENTAL

8-week Smartphone delivered CBT for MDD.

Device: Smartphone-delivered CBT for MDD

8 Week Waitlist Control

OTHER

8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).

Device: Smartphone-delivered CBT for MDD

Interventions

Smartphone-delivered CBT for MDD DEVICE

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.

8 Week Waitlist Control; Smartphone-delivered CBT for MDD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Current diagnosis of primary DSM-5 MDD, based on MINI
• Currently living in the United States

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Koa Health B.V.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Phycology

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 26, 2025

Record last verified: 2025-05

Locations

US (1)