Investigating brain activation in depressed adolescents undergoing Behavioral Activation therapy

Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression

This study is testing how Behavioral Activation therapy affects brain activity in depressed teenagers to see if it helps them feel better and be more motivated.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 15 Years to 17 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT05548244 on ClinicalTrials.gov

What this trial studies

This study aims to compare brain activation patterns in depressed adolescents before, during, and after Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). The research will focus on understanding how BA influences neural mechanisms related to behavioral avoidance and motivation. A total of approximately 136 participants, including 96 treatment-seeking adolescents and 40 healthy controls, will be recruited to assess both behavioral and neuroimaging measures. The study will involve multiple fMRI sessions to track changes in brain activity associated with symptom improvement.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 15-17 who have a current diagnosis of Major Depressive Disorder.

Not a fit: Patients with bipolar disorder, schizophrenia, or other severe mental health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of how Behavioral Activation therapy works, potentially leading to more effective treatments for adolescent depression.

How similar studies have performed: Other studies have shown promise in using neuroimaging to understand treatment responses in depression, making this approach both relevant and potentially impactful.

Eligibility criteria

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.

Where this trial is running

Atlanta, Georgia and 2 other locations

• Emory University — Atlanta, Georgia, United States (Recruiting)
• Facility for Education and Research in Neuroscience (FERN) — Atlanta, Georgia, United States (Recruiting)
• Child and Adolescent Mood Program (CAMP) — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Wade E Craighead, PhD — Emory University
• Study coordinator: Wade E Craighead, PhD

Conditions Depression; Behavioral Activation; fMRI