RecruitingNot ApplicableNCT05136703

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)


Sponsor

Florida International University

Enrollment

150 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether treating depression in people living with HIV improves brain function and immune health. It uses brain MRI scans and immune markers to understand the link between mood and the immune system in HIV. **You may be eligible if...** - You are 18 or older - You are HIV-positive and on antiretroviral (HIV) medications - You have been diagnosed with major depression - Your HIV viral load is suppressed (below 200 copies/mL) - You are able to have an MRI scan (no claustrophobia, no metal implants, BMI under 40) **You may NOT be eligible if...** - You are not on HIV medication - Your HIV is not virologically suppressed - You cannot have an MRI (claustrophobia, pacemaker, metal implants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

CBT-AD is a behavioral intervention administered either in person or via Zoom. Each session lasts approximately 50 minutes. Participants will receive up to 12 individually delivered sessions over 4 months. Participants receive up to three individually delivered booster sessions through 6 months.

BEHAVIORALAntiretroviral Therapy (ART) Adherence Counseling

This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.


Locations(2)

University of Miami Neuroimaging Facility

Coral Gables, Florida, United States

Care Resource - Midtown Miami

Miami, Florida, United States

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NCT05136703


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