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Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cognitive-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.

BEHAVIORAL

Antiretroviral Therapy (ART) Adherence Counseling

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida International University

    lead OTHER

Principal Investigators

  • Adam W Carrico, PhD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05136703 on ClinicalTrials.gov