Home › Depression › NCT05136703
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
About the 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.
What is being tested
- Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) (behavioral)
- Antiretroviral Therapy (ART) Adherence Counseling (behavioral)
Sponsor: Florida International University · Participants: 150 · Started: Aug 30, 2022
Contact the study team
- Adam W Carrico, PhD · Phone: (305) 348-7887
Official record on ClinicalTrials.gov — NCT05136703
Locations in the U.S.
| Florida | University of Miami Neuroimaging Facility, Coral Gables Care Resource - Midtown Miami, Miami |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.