Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Florida International University
150 participants
Aug 30, 2022
INTERVENTIONAL
Conditions
Summary
The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.
Eligibility
Inclusion Criteria7
- Age 18 or older
- Speaks and reads English
- Verified HIV+ status with antiretroviral medications bearing his/her name
- Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
- If prescribed antidepressants, on a stable regimen and dose for at least 2 months
- Suppressed HIV viral load (\< 200 copies/mL)
- Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \< 40)
Exclusion Criteria5
- Unable to provide informed consent
- Active, untreated major mental illness
- Pregnancy at baseline
- Received CBT for depression in the past 2 years
- \. Otherwise eligible but does not complete the run-in period that includes the baseline assessment, biospecimen collection, the fMRI visit, and a separately scheduled randomization visit
Interventions
CBT-AD is a behavioral intervention administered either in person or via Zoom. Each session lasts approximately 50 minutes. Participants will receive up to 12 individually delivered sessions over 4 months. Participants receive up to three individually delivered booster sessions through 6 months.
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05136703