Mechanisms of Behavioral Activation (BA)
Recruiting · NCT05548244 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
Baseline assessment proceduresBehavioral Activation Therapy
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.
Who can take part
Age range
15 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
3 locations listed across 1 US state.
- Emory University - Atlanta, Georgia, United States
- Facility for Education and Research in Neuroscience (FERN) - Atlanta, Georgia, United States
- Child and Adolescent Mood Program (CAMP) - Atlanta, Georgia, United States