RecruitingDepressionHIV-1-infectionInflammation
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Florida International University
You may qualify if…
- ✓ 1. Age 18 or older
- ✓ 2. Speaks and reads English
- ✓ 3. Verified HIV+ status with antiretroviral medications bearing his/her name
- ✓ 4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
- ✓ 5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months
- ✓ 6. Suppressed HIV viral load (\< 200 copies/mL)
- ✓ 7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \< 40)
You may not qualify if…
- ✕ 1. Unable to provide informed consent
- ✕ 2. Active, untreated major mental illness
- ✕ 3. Pregnancy at baseline
- ✕ 4. Received CBT for depression in the past 2 years
- ✕ 5. 5\. 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
Where it's recruiting
Florida
Coral Gables · Miami
Source: ClinicalTrials.gov · NCT05136703 · last updated 2026-02-06