Actively Recruiting

Phase Not Applicable
Age: 15Years - 17Years
All Genders
Healthy Volunteers
NCT05548244

Mechanisms of Behavioral Activation (BA)

Led by Emory University · Updated on 2025-04-10

136

Participants Needed

3

Research Sites

221 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.

CONDITIONS

Official Title

Mechanisms of Behavioral Activation (BA)

Who Can Participate

Age: 15Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female adolescents ages 15-17
  • Current diagnosis of Major Depressive Disorder (MDD) confirmed by K-SADS-PL
  • CDRS-R raw score greater than 45 (T-score over 65) at baseline
  • Estimated full scale IQ above 80 as measured by WASI-II
  • Able to receive outpatient care
  • Willing to avoid other psychosocial treatments during the study
  • Not taking psychotropic medications within two weeks prior to consent (four weeks for fluoxetine), except ADHD stimulant medication
  • Depressed participants must have access to required technology (smartphone, tablet, or desktop computer) to complete ecological momentary assessment (EMA)
  • Healthy controls must not meet criteria for MDD and have a CDRS-R raw score below 28 (T-score under 52)
Not Eligible

You will not qualify if you...

  • Current or past diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychosis NOS
  • Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder (OCD), or autism spectrum disorders
  • Taking psychotropic medications prior to entry (except allowed ADHD stimulants)
  • Estimated IQ below 80
  • Alcohol or drug dependence or abuse within the last 3 months
  • Potential or confirmed neurological disorder or epilepsy
  • Claustrophobia
  • Medical conditions preventing fMRI participation
  • Imminent and serious suicidality
  • Medical conditions that take precedence over MDD
  • Pregnancy
  • Substance use (excluding nicotine) within two weeks before fMRI scan
  • Left-handedness
  • Nicotine use within 3 hours of fMRI scan
  • History of traumatic brain injury or unconsciousness for more than 30 minutes
  • Recent change in ADHD stimulant medication within 30 days of fMRI scan
  • Non-compliance or inability to complete at least 70% of EMA assessments or lack of required smartphone device

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Facility for Education and Research in Neuroscience (FERN)

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Child and Adolescent Mood Program (CAMP)

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

W

Wade E Craighead, PhD

CONTACT

M

Michael Treadway, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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