NCT05136703Recruiting
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 15 Nov 2021
- Start date
- 30 Aug 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Florida International University
- Diseases
- HIV
- NCT number
- NCT05136703
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 30 Aug 2022 to the primary completion date, 30 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received CBT for depression in the past 2 years
Other illness
- Active, untreated major mental illness
Other
- Unable to provide informed consent
- Pregnancy at baseline
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Neuroimaging Facility Coordinator of this site? Confirm its status | Coral Gables | United States | Recruiting |
| Care Resource - Midtown Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.