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Behavioral Intervention

Computer-Assisted CBT for Depression

N/A
Waitlist Available
Led By Yvette I Sheline, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experimental group: Diagnosis of MDD, experiencing current episode as determined by SCID-5; Current major depressive episode of moderate severity, as determined by MADRS score of 20 or higher
Be between 18 and 65 years old
Must not have
Cannot complete questionnaires written in English
Centrally acting antiadrenergic agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

This trial is investigating whether computer-assisted cognitive behavioral therapy (CCBT) can help treat depression by looking at brain activity before and after treatment.

Who is the study for?
This trial is for adults aged 18-60 with Major Depressive Disorder (MDD) currently experiencing a moderate episode, and healthy controls without MDD. Participants must be willing to avoid psychotropic medications during the study, have access to a computer or tablet, own a smartphone for app use, and speak English fluently.
What is being tested?
The trial tests Computer-Augmented Cognitive Behavioral Therapy (CCBT) in treating depression. It involves both computer-based therapy and sessions with a therapist. The study compares brain activity changes between those receiving immediate CCBT versus those on an initial waitlist followed by CCBT.
What are the potential side effects?
Since this intervention is non-medical involving cognitive behavioral therapy augmented by computer assistance, typical drug-related side effects are not expected. However, participants may experience discomfort from wearing an actigraph or stress related to discussing personal issues during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing a moderate to severe episode of depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot fill out forms in English.
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I am not taking any central nervous system medications for blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Resting State Functional Connectivity: MDD vs Controls
Secondary study objectives
Resting state functional connectivity: Immediate CCBT vs Waitlist followed by CCBT

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Late CCBTExperimental Treatment1 Intervention
Intervention: Waitlist followed by Computer-Augmented Cognitive Behavioral Therapy Half of participants presenting with MDD will be randomized to be waitlisted for up to 4 weeks and will receive CCBT within 4 weeks; imaging data will also be collected pre--treatment, following waitlist, and post-treatment of CCBT. This arm will serve as the equivalent of a "placebo comparator" arm during the waitlist; and then as an experimental arm when receiving 8 weeks of CCBT treatment.
Group II: Early CCBTExperimental Treatment1 Intervention
Intervention: Computer-Augmented Cognitive Behavioral Therapy Half of participants presenting with MDD will be randomized to receive 8 weeks of Computer-Augmented Cognitive Behavior Therapy (CCBT) immediately after completing pre-treatment assessments; imaging data will be collected pre- and post-treatment.
Group III: Matched ComparisonActive Control1 Intervention
No Intervention: Matched Comparison Healthy controls will act as a matched comparator. Participants will complete pre-treatment assessments and imaging.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,013,037 Total Patients Enrolled
69 Trials studying Depression
29,855 Patients Enrolled for Depression
Yvette I Sheline, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Depression
97 Patients Enrolled for Depression

Media Library

CCBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03096886 — N/A
Depression Research Study Groups: Early CCBT, Late CCBT, Matched Comparison
Depression Clinical Trial 2023: CCBT Highlights & Side Effects. Trial Name: NCT03096886 — N/A
CCBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03096886 — N/A
Depression Patient Testimony for trial: Trial Name: NCT03096886 — N/A
~11 spots leftby Sep 2025
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