Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Last updated: February 2, 2025
Sponsor: Florida International University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Inflammation

Treatment

Antiretroviral Therapy (ART) Adherence Counseling

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

Clinical Study ID

NCT05136703
20210773
R01MH128868
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 clinicalinterview (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., noclaustrophobia, no metal implants, no pacemaker, and BMI < 40)

Exclusion

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. Otherwise eligible but does not complete baseline biospecimen collection and fMRIvisit

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Antiretroviral Therapy (ART) Adherence Counseling
Phase:
Study Start date:
August 30, 2022
Estimated Completion Date:
July 31, 2027

Study Description

The overarching goal of this randomized controlled trial (RCT) is to identify the causal pathways that drive depressive symptoms among people with HIV (PWH). The scientific premise is that evidence-based depression treatment is an innovative, experimental probe to determine the neural substrates of depression and mechanistic relevance of microbiome-gut-brain (MGB) axis changes during and after Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) on brain and behavioral function.

The proposed causal pathway is that reductions in depressive symptoms following the delivery of CBT-AD treatment will trigger a cascade of alterations in the MGB axis. Specifically, CBT-AD related decreases in depressive symptoms will induce alterations in gut dysbiosis, decrease microbial translocation, and improve soluble neuroactive markers of peripheral immune dysregulation. Our efforts to elucidate the immunologic mechanisms whereby CBT-AD could improve neurobehavioral outcomes will also focus on an established leukocyte signaling pathway, the Conserved Transcriptional Response to Adversity (CTRA), which has been shown to be responsive to behavioral interventions and psychosocial factors outside of HIV.

Connect with a study center

  • University of Miami Neuroimaging Facility

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Care Resource - Midtown Miami

    Miami, Florida 33137
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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