Trials / Recruiting
RecruitingNCT05548244
Mechanisms of Behavioral Activation (BA)
Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- Sponsor
- Emory University · Academic / Other
- Sex
- All
- Age
- 15 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The primary aim of this study is to investigate the behavioral and neurobiological factors predicting response to Behavior Activation (BA), a psychosocial treatment for Major Depressive Disorder (MDD), in adolescents. The recruitment age pool will be adolescents ages 15-17. The investigators plan to recruit 40 healthy controls and 96 treatment-seeking adolescents for an overall sample of \~136 participants, Individuals who reach the age of majority (18) during the study will be re-consented as adults and allowed to continue participating in the study. A healthy control group will be included to assess stability in behavioral and neuroimaging measures over the course of participation in the study. The fMRI scan schedule will include three task-based sessions (baseline, after session 7, and after endpoint) and two (sessions 3 \& 9). "behavioral-scheduling-in-the-scanner" sessions Primary results will focus on symptom change within patients and their association to measures of low motivation and threat avoidance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2023-01-30
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2022-09-21
- Last updated
- 2025-04-10
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05548244. Inclusion in this directory is not an endorsement.