Behavioral Activation Therapy for Depression in Adolescents

This study is looking at how Behavioral Activation Therapy (BA) helps teenagers aged 15-17 with depression. BA is a type of therapy that focuses on increasing rewarding activities. You would attend up to 16 individual therapy sessions over 16 weeks, with monthly booster sessions for 6 months afterward. Researchers will use fMRI (functional magnetic resonance imaging), a type of brain scan, to see how your brain activity changes before, during, and after therapy. They want to understand if BA works differently for people who avoid things due to low motivation versus those who avoid things due to threat. The study aims to enroll about 136 participants, including some healthy teenagers for comparison. To join, you need a current diagnosis of Major Depressive Disorder (MDD) and an IQ above 80. The study will measure changes in your depression symptoms to see how well the therapy works.

Study design
This is an interventional study involving about 136 participants, including both adolescents with depression and a healthy control group.
What's involved
You would have up to 16 individual therapy sessions over 16 weeks, with monthly booster sessions for 6 months. There will also be fMRI brain scans at baseline, after session 7, and after the last session, plus two additional behavioral-scheduling-in-the-scanner sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will have monthly booster sessions throughout a 6-month follow-up period after the main 16-week intervention.

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NCT05548244

Mechanisms of Behavioral Activation (BA)

Recruiting
NAAges 15–17Interventional
Emory University
~136 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Behavioral Activation TherapyBaseline assessment procedures

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Diagnostic Interview Status (CDRS-R) total score from baseline
Measured over Baseline, week 16 post intervention
+1 more outcome measured
Depression
3 sites across 1 states
Georgia3
  • Michael Treadway, PhD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

Male and female adolescents ages 15-17;
current MDD diagnosis as determined by K-SADS-PL,
CDRS-R raw score \> 45 (T-score \> 65) at baseline;
estimated full scale IQ \> 80 as determined by the WASI-II;
able to receive outpatient care;
willing to not partake in other psychosocial treatments;
not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD.
Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study.
Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score \< 52).

Exclusion

Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS;
current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders;
taking psychotropic medications prior to entry;
estimated IQ \< 80; alcohol/drug dependence or abuse within the last 3 months;
potential/confirmed neurological disorder or epilepsy;
claustrophobia;
presence of a medical condition that precludes fMRI;
endorsement of imminent and serious suicidality;
medical conditions that take precedence over the presence of MDD;
pregnancy;
substance use (excluding nicotine) within two weeks of the fMRI scan;
left-handedness;
nicotine use within 3 hours of the fMRI scan;
history of traumatic brain injury or of being unconscious for more than 30 minutes;
a stimulant regime for ADHD which has changed within 30 days of the fMRI scan.
Non-compliance (i.e. \<70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.
  • Change in Diagnostic Interview Status (CDRS-R) total score from baselineBaseline, week 16 post intervention

    Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.

  • Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)Week 8 post intervention (Midpoint), week 16 post intervention

    The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (\<4).