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Behavioural Intervention

Smartphone CBT for Depression

N/A

Waitlist Available

Led By Sabine Wilhelm, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Current diagnosis of primary DSM-5 MDD, based on MINI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up endpoint (week 8)

Awards & highlights

Study Summary

This trial is testing whether a smartphone app can effectively treat major depressive disorder.

Who is the study for?

This trial is for adults over 18 with Major Depressive Disorder (MDD) who live in the US and haven't had much CBT before. They must be stable on any current meds, not have severe substance issues, or acute suicidal thoughts. Tech literacy and owning a smartphone with data are required.Check my eligibility

What is being tested?

The study tests if using a smartphone app to do cognitive behavioral therapy (CBT) helps people with MDD feel better compared to those just waiting for treatment. It's measured by changes in depression scores after 8 weeks.See study design

What are the potential side effects?

Since this trial involves psychological therapy via an app, there may not be direct side effects like with medications; however, some might experience discomfort discussing personal issues or temporary increases in distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with major depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ endpoint (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~endpoint (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and endpoint (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Smartphone-delivered CBT for MDDExperimental Treatment1 Intervention

8-week Smartphone delivered CBT for MDD.

Group II: 8 Week Waitlist ControlExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,243 Total Patients Enrolled

184 Trials studying Depression

29,444 Patients Enrolled for Depression

Koa Health B.V.Industry Sponsor

5 Previous Clinical Trials

308 Total Patients Enrolled

Sabine Wilhelm, PhDPrincipal InvestigatorMassachusetts General Hospital

12 Previous Clinical Trials

809 Total Patients Enrolled

2 Trials studying Depression

250 Patients Enrolled for Depression

Media Library

Depression Research Study Groups: Smartphone-delivered CBT for MDD, 8 Week Waitlist Control

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor currently have any open positions for study participants?

"According to clinicaltrials.gov, this research is not currently in need of participants. Although the trial was initially published on September 1st 2023 and most recently updated October 3rd 2022, it appears that 1296 other experiments are searching for candidates at present."

Answered by AI