Actively Recruiting
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Led by Florida International University · Updated on 2026-02-06
150
Participants Needed
2
Research Sites
278 weeks
Total Duration
On this page
Sponsors
F
Florida International University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Speaks and reads English
- Verified HIV positive status with antiretroviral medications prescribed in their name
- Current diagnosis of Major Depressive Disorder using a structured clinical interview or Hamilton Rating Scale for Depression score of 7 or greater
- If on antidepressants, stable dose and regimen for at least 2 months
- Suppressed HIV viral load (less than 200 copies/mL)
- Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (no claustrophobia, no metal implants, no pacemaker, BMI less than 40)
You will not qualify if you...
- Unable to provide informed consent
- Active, untreated major mental illness
- Pregnancy at baseline
- Received Cognitive-Behavioral Therapy for depression in the past 2 years
- Otherwise eligible but does not complete the run-in period including baseline assessment, biospecimen collection, fMRI visit, and randomization visit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Miami Neuroimaging Facility
Coral Gables, Florida, United States, 33146
Actively Recruiting
2
Care Resource - Midtown Miami
Miami, Florida, United States, 33137
Actively Recruiting
Research Team
A
Adam W Carrico, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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