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Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
RECRUITINGN/ASponsored by Florida International University
Actively Recruiting
PhaseN/A
SponsorFlorida International University
Started2022-08-30
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05136703
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
DepressionHIV-1-infectionInflammation
Locations2 sites
University of Miami Neuroimaging Facility
Coral Gables, Florida, 33146
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Actively Recruiting
PhaseN/A
SponsorFlorida International University
Started2022-08-30
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05136703