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Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

ConditionsDepressionHIV-1-infectionInflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida International University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to provide informed consent

Active, untreated major mental illness

Pregnancy at baseline

Received CBT for depression in the past 2 years

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Behavioral

    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.

  • Antiretroviral Therapy (ART) Adherence Counseling

    Behavioral

    This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)Experimental treatment 2 interventions
Group B: Wait-List Control (WLC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in resting state activation of the negative valence system

Measured by functional Magnetic Resonance Imaging (fMRI)

Time frame
6 Months
2

Change in connectivity of the negative valence system

Measured by functional Magnetic Resonance Imaging (fMRI)

Time frame
6 Months

Secondary outcomes

1

Depressive Symptoms

The Hamilton Rating Scale for Depression is an interviewer-administered measure that has a total score ranging from 0-52 with the higher score indicating greater depressive symptoms

Time frame
6 Months
2

Alterations in gut microbiota

Measured via 16s sequencing of the gut microbiome using rectal swabs and fecal samples

Time frame
4 months
3

Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway

Measured using Ribonucleic Acid (RNA) sequencing from peripheral blood mononuclear cells

Time frame
4 Months
4

Soluble Markers of Microbial Translocation

Enzyme-linked immunosorbent assay (ELISA) methods will be employed to measure lipopolysaccharide binding protein (LBP) levels in plasma samples. Log10 will be the unit of measure.

Time frame
4 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida International University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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