Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05136703

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Led by Florida International University · Updated on 2026-02-06

150

Participants Needed

2

Research Sites

278 weeks

Total Duration

On this page

Sponsors

F

Florida International University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Speaks and reads English
  • Verified HIV positive status with antiretroviral medications prescribed in their name
  • Current diagnosis of Major Depressive Disorder using a structured clinical interview or Hamilton Rating Scale for Depression score of 7 or greater
  • If on antidepressants, stable dose and regimen for at least 2 months
  • Suppressed HIV viral load (less than 200 copies/mL)
  • Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (no claustrophobia, no metal implants, no pacemaker, BMI less than 40)
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Active, untreated major mental illness
  • Pregnancy at baseline
  • Received Cognitive-Behavioral Therapy for depression in the past 2 years
  • Otherwise eligible but does not complete the run-in period including baseline assessment, biospecimen collection, fMRI visit, and randomization visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University of Miami Neuroimaging Facility

Coral Gables, Florida, United States, 33146

Actively Recruiting

2

Care Resource - Midtown Miami

Miami, Florida, United States, 33137

Actively Recruiting

Loading map...

Research Team

A

Adam W Carrico, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here