NCT05548244 Mechanisms of Behavioral Activation (BA)
| NCT ID | NCT05548244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2023-01-30 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Michael Treadway, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05548244 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 17 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05548244 currently recruiting?
Yes, NCT05548244 is actively recruiting participants. Contact the research team at ecraigh@emory.edu for enrollment information.
Where is the NCT05548244 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT05548244 clinical trial?
NCT05548244 is sponsored by Emory University. The principal investigator is Michael Treadway, PhD at Emory University. The trial plans to enroll 136 participants.
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