Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Recruiting now · Not applicable

Conditions studied: Depression, HIV-1-infection, Inflammation

In brief

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.

Key facts

Study ID

NCT05136703

Run by

Florida International University

People needed

150

Starts

2022-08-30

Expected to finish

2027-12-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Speaks and reads English
• Verified HIV+ status with antiretroviral medications bearing his/her name
• Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
• If prescribed antidepressants, on a stable regimen and dose for at least 2 months
• Suppressed HIV viral load (< 200 copies/mL)
• 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…

• Unable to provide informed consent
• Active, untreated major mental illness
• Pregnancy at baseline
• Received CBT for depression in the past 2 years
• 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 is running

• University of Miami Neuroimaging Facility — Coral Gables, Florida, United States (enrolling)
• Care Resource - Midtown Miami — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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