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Behavioral Intervention

Computer-Augmented Cognitive Behavioral Therapy 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am currently experiencing a moderate to severe episode of depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Resting State Functional Connectivity: MDD vs Controls

Secondary outcome measures

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,009 Previous Clinical Trials

42,894,563 Total Patients Enrolled

68 Trials studying Depression

29,318 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

Frequently Asked Questions

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

Who qualifies to take part in this clinical investigation?

"To meet the criteria of this clinical trial, potential participants should be between 18 and 60 years old with a confirmed diagnosis of melancholia. Acceptance is limited to 90 individuals in total."

Answered by AI

Is enrollment in this experiment still open?

"According to clinicaltrials.gov, this medical study is still open for enrollment and has been since June 5th 2017. The information was last updated on December 5th 2022."

Answered by AI

Do you accept applicants aged 35 and over for this experiment?

"This trial is designed for adults between 18 and 60. Patients younger than 18 years old can find 410 other clinical trials to consider, while those over 65 have access to 1465 different options."

Answered by AI

What is the total sample size for this clinical investigation?

"Affirmative. Clinicaltrials.gov records confirm that this research project, initially posted on June 5th 2017 and recently updated on December 5th 2022 is currently enrolling participants. In total, 90 patients are needed to be recruited from 1 trial site."

Answered by AI

Who else is applying?

What state do they live in?

Maryland

Pennsylvania

New Jersey

How old are they?

18 - 65

What site did they apply to?

University of Pennsylvania

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

What questions have other patients asked about this trial?

If I get off the current drugs I am on will there be another drug that will help?

PatientReceived 1 prior treatment

Why did patients apply to this trial?

I prefer text. Again as previously stated I have tried several medications and none of them have worked.

PatientReceived no prior treatments

I've suffered from MDD for over two decades. I've tried dozens of treatments, but none have brought more than partial relief.

PatientReceived no prior treatments

Deal with depression and I don't think the medications I am on are enough. I no longer suffer from suicidal thoughts so that's a good thing that stopped since being on them. I just want to feel happier.

PatientReceived 2+ prior treatments