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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met