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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

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
Roger McIntosh, PhD305-243-2047r.mcintosh@miami.edu
Care Resource - Midtown Miami
Miami, Florida, 33137
Adam W Carrico, PhD(305) 348-7887acarrico@fiu.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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