Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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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