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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
Must not have
Lifetime bipolar disorder or psychosis
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up endpoint (week 8)
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.
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I have been diagnosed with major depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never been diagnosed with bipolar disorder or psychosis.
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My psychotropic medication dose has been stable for the last 2 months.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in MDD severity (SIGH-D) at the end of treatment/waitlist period.
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,248 Total Patients Enrolled
191 Trials studying Depression
33,830 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
~75 spots leftby Sep 2027
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