Investigating how depression treatment affects gut health and brain function in people with HIV
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
This study is testing whether treating depression with therapy can improve gut health and brain function in people living with HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 2 sites (Coral Gables, Florida and 1 other locations) |
| Trial ID | NCT05136703 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to explore the effects of cognitive-behavioral therapy for adherence and depression (CBT-AD) on the gut microbiome, immune system, and brain function in individuals living with HIV. The study will assess how reductions in depressive symptoms can lead to changes in the microbiome-gut-brain axis, potentially improving neurobehavioral outcomes. Participants will undergo fMRI scans and biospecimen collection to evaluate the biological mechanisms involved in these changes. The research seeks to establish a causal relationship between depression treatment and its effects on health in the context of HIV.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older who are HIV positive, have a current diagnosis of major depressive disorder, and are stable on their antidepressant regimen.
Not a fit: Patients who are actively untreated for major mental illness or have received cognitive-behavioral therapy for depression in the past two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental and physical health outcomes for individuals living with HIV by integrating psychological treatment with biological health improvements.
How similar studies have performed: While the integration of cognitive-behavioral therapy and microbiome research is innovative, similar studies have shown promising results in understanding the interplay between mental health and biological factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 or older 2. Speaks and reads English 3. Verified HIV+ status with antiretroviral medications bearing his/her name 4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater 5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months 6. Suppressed HIV viral load (\< 200 copies/mL) 7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \< 40) Exclusion Criteria: 1. Unable to provide informed consent 2. Active, untreated major mental illness 3. Pregnancy at baseline 4. Received CBT for depression in the past 2 years 5. 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 this trial is running
Coral Gables, Florida and 1 other locations
- University of Miami Neuroimaging Facility — Coral Gables, Florida, United States (Recruiting)
- Care Resource - Midtown Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Adam W Carrico, PhD — Florida International University
- Study coordinator: Adam W Carrico, PhD
- Email: acarrico@fiu.edu
- Phone: (305) 348-7887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.