Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703 | Recruiting DMC

• 2 other identifiers: 20210773R01MH128868
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression; HIV-1-infection; Inflammation

Keywords

Depression; Microbiome; HIV; CBT-AD; Gut; Brain

Outcome Measures

Primary Outcomes (2)

• Change in resting state activation of the negative valence system

  Measured by functional Magnetic Resonance Imaging (fMRI)

  6 Months

• Change in connectivity of the negative valence system

  Measured by functional Magnetic Resonance Imaging (fMRI)

  6 Months

Secondary Outcomes (7)

• Depressive Symptoms

  6 Months

• Alterations in gut microbiota

  4 months

• Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway

  4 Months

• Soluble Markers of Microbial Translocation

  4 Months

• Soluble Markers of Immune Activation and Inflammation

  4 Months

Study Arms (2)

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

EXPERIMENTAL

Participants randomized to receive CBT-AD immediately will complete up to 15 individual sessions (12 session with 3 booster sessions) focused on depression and one session of ART Adherence counseling during the four months following randomization.

Behavioral: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD); Behavioral: Antiretroviral Therapy (ART) Adherence Counseling

Wait-List Control (WLC)

EXPERIMENTAL

Participants randomized to the WLC condition will receive one session of ART adherence counseling immediately following randomization. After six months, WLC participants will have the opportunity to receive 15 individually delivered CBT-AD sessions (12 sessions and 3 booster sessions) focused on depression.

Behavioral: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD); Behavioral: Antiretroviral Therapy (ART) Adherence Counseling

Interventions

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.

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD); Wait-List Control (WLC)

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.

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD); Wait-List Control (WLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unable to provide informed consent
• Active, untreated major mental illness
• Pregnancy at baseline
• Received CBT for depression in the past 2 years
• \. 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

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Miami Neuroimaging Facility

Coral Gables, Florida, 33146, United States

RECRUITING

Care Resource - Midtown Miami

Miami, Florida, 33137, United States

RECRUITING

MeSH Terms

Conditions

Depression; Inflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam W Carrico, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam W Carrico, PhD

CONTACT

(305) 348-7887; acarrico@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 29, 2021
• Study Start: August 30, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)