Recruiting

Behavioral Activation

Sponsor:

Emory University

Code:

NCT05548244

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 15 - 17

Healthy Volunteers: Accepted

Interventions

Behavioral Activation Therapy

Baseline assessment procedures

Study Details

Brief summary:

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

Depression

Study ID

NCT05548244

Start date

Jan 30, 2023

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

136 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MDD patients

Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.

Interventions

Behavioral Activation Therapy

Participants will be seen for a maximum of 16 sessions of therapy focused on increasing rewarding behaviors (16 individual therapy sessions of 1-hour, 2 of which include the BSIS component) over 16 weeks. BA intervention includes monthly booster sessions offered throughout 6-month follow up. If needed, two extra sessions will be allowed during treatment.

Baseline assessment procedures

Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ.

Primary outcome measure

  • Change in Diagnostic Interview Status (CDRS-R) total score from baseline [ Time Frame: Baseline, week 16 post intervention ]
  • Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE) [ Time Frame: Week 8 post intervention (Midpoint), week 16 post intervention ]

Central Contacts and Locations

Central contacts

Wade E Craighead, PhD

4047273287ecraigh@emory.edu

Michael Treadway, PhD

mtreadway@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Wade E Craighead, PhD

ecraigh@emory.edu

Facility for Education and Research in Neuroscience (FERN)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Michael Treadway, PhD

mtreadway@emory.edu

Child and Adolescent Mood Program (CAMP)

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Wade E Craighead, PhD

ecraigh@Emory.edu

More Information

Sponsor

Emory University

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Behavioral Activation
  • fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-01.