Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Recruiting · NCT05136703 · Interventional (participants receive a specific treatment) · Lead sponsor: Florida International University
View the official record on ClinicalTrials.gov →Interventions studied
Antiretroviral Therapy (ART) Adherence CounselingCognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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)
Exclusion criteria
- Unable to provide informed consent
- Active, untreated major mental illness
- Pregnancy at baseline
- Received CBT for depression in the past 2 years
- 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 is running
2 locations listed across 1 US state.
- University of Miami Neuroimaging Facility - Coral Gables, Florida, United States
- Care Resource - Midtown Miami - Miami, Florida, United States