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Recruiting NCT05136703

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

No phase Interventional Depression HIV-1-infection Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD), Antiretroviral Therapy (ART) Adherence Counseling.
Who it may be relevant to
Registry conditions: Depression, HIV-1-infection, Inflammation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Behavioral Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
    CBT-AD is a behavioral intervention administered either in person or via Zoom. Each session lasts approximately 50 minutes. Participants will receive up to 12 individually delivered sessions over 4 months. Participants receive up to three individually delivered booster sessions through 6 months.
  • Behavioral Antiretroviral Therapy (ART) Adherence Counseling
    This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Primary outcome measures

  • Change in resting state activation of the negative valence system [Time frame: 6 Months]
  • Change in connectivity of the negative valence system [Time frame: 6 Months]
Secondary outcome measures (7)
  • Depressive Symptoms [Time frame: 6 Months]
  • Alterations in gut microbiota [Time frame: 4 months]
  • Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway [Time frame: 4 Months]
  • Soluble Markers of Microbial Translocation [Time frame: 4 Months]
  • Soluble Markers of Immune Activation and Inflammation [Time frame: 4 Months]
  • Soluble Markers of Dysregulated Neurotransmitter Synthesis [Time frame: 4 Months]
  • Neurocognitive Functioning [Time frame: 6 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

United States · 2 centers
  • University of Miami Neuroimaging Facility — Coral Gables
  • Care Resource - Midtown Miami — Miami

Identifiers

NCT: NCT05136703 · 20210773 · R01MH128868

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗