Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Launched by FLORIDA INTERNATIONAL UNIVERSITY · Nov 15, 2021

Keywords

ClinConnect Summary

The TRIDENT trial is a research study aimed at understanding how a specific type of psychological treatment called cognitive-behavioral therapy (CBT) can help people with depression who are also living with HIV. The researchers want to see how this treatment affects the gut microbiome (the tiny organisms in our gut that help with digestion and overall health), the immune system, and brain function. By learning more about these connections, the study hopes to find better ways to support the health of individuals facing both depression and HIV.

To participate in the trial, you need to be at least 18 years old, speak and read English, and have a confirmed HIV-positive status while receiving appropriate medication. You should also have a current diagnosis of major depressive disorder, and if you are on antidepressants, they should be stable for at least two months. Participants will undergo tests like brain scans (fMRI) and provide some biological samples to help researchers gather important data. This study is actively looking for participants, and it’s a chance to contribute to research that could improve treatment options for others in similar situations.

Gender

ALL

Eligibility 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