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Behavioral Activation Therapy for Depression

N/A
Recruiting
Led By Wade E Craighead, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current MDD diagnosis as determined by K-SADS-PL
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 post intervention (midpoint), week 16 post intervention
Awards & highlights

Study Summary

This trial will compare brain activation of depressed adolescents before, during, and after a course of Behavioral Activation therapy, using functional magnetic resonance imaging. The goal is to see if BA therapy affects different neural mechanisms for behavioral avoidance associated with low motivation, as compared to threat avoidance.

Who is the study for?
Adolescents aged 15-17 with major depressive disorder (MDD) can join this trial. They must have a certain level of depression severity, an IQ over 80, and agree not to take other psychosocial treatments or psychotropic drugs before the study. Healthy controls without MDD are also needed. Exclusions include drug/alcohol abuse, serious medical conditions that overshadow MDD, claustrophobia, pregnancy, and inability to complete assessments.Check my eligibility
What is being tested?
The trial is testing how Behavioral Activation Therapy affects brain activity in depressed teens using fMRI scans before, during and after therapy sessions. It aims to see if the therapy impacts areas of the brain related to motivation differently than those linked with threat avoidance.See study design
What are the potential side effects?
Behavioral Activation Therapy doesn't involve medication so typical drug side effects aren't expected; however participants may experience discomfort from being in an MRI machine such as claustrophobia or anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with major depressive disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 post intervention (midpoint), week 16 post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 post intervention (midpoint), week 16 post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)
Change in Diagnostic Interview Status (CDRS-R) total score from baseline
Secondary outcome measures
Change in Beck Depression Inventory (BDI-II)

Side effects data

From 2022 Phase 4 trial • 494 Patients • NCT03688100
17%
All-Cause Mortality
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients: Medication Management (MEDS)
Patients: Behavioral Activation Therapy (BA)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MDD patientsExperimental Treatment2 Interventions
Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation Therapy
2018
Completed Phase 4
~770

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,437 Total Patients Enrolled
59 Trials studying Depression
8,880 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,971 Total Patients Enrolled
665 Trials studying Depression
251,298 Patients Enrolled for Depression
Wade E Craighead, PhDPrincipal InvestigatorEmory University

Media Library

Behavioral Activation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05548244 — N/A
Depression Research Study Groups: MDD patients
Depression Clinical Trial 2023: Behavioral Activation Therapy Highlights & Side Effects. Trial Name: NCT05548244 — N/A
Behavioral Activation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548244 — N/A

Frequently Asked Questions

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

For whom is this clinical trial best suited?

"This clinical study is enrolling 136 adolescents between 15-17 years of age who suffer from depression. To be eligible, male and female candidates must present a CDRS-R raw score above 45 (T-score > 65), possess an estimated full scale IQ higher than 80, abstain from other psychosocial treatments as well as psychotropic medications in the two weeks prior to consent with the exception of those prescribed for ADHD management. Additionally, participants should have access to digital platforms like smartphones or tablets that allow them to complete their EMA portion of the trial. As for healthy controls, they cannot meet criteria for MDD and their CD"

Answered by AI

Are enrollees being accepted for this experiment at the present time?

"As per clinicaltrials.gov, this medical study is not taking on participants at the moment - it was first published November 1st 2022 and recently modified October 11th 2022. However, 1133 other studies are currently recruiting patients."

Answered by AI

Can persons less than seventy years of age partake in this trial?

"This experiment is open to adolescents between the ages of 15 and 17."

Answered by AI
~91 spots leftby May 2027