Investigating how depression treatment affects gut health and brain function in people with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.