Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Florida International University
Study ID
NCT05136703
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Aug 30, 2022
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
    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.
  • Experimental: Wait-List Control (WLC)
    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.

Primary Outcome Measure

Change in resting state activation of the negative valence system [ Time Frame: 6 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami Neuroimaging FacilityCoral GablesFlorida33146
Roger McIntosh, PhD
[email protected]
305-243-2047
Care Resource - Midtown MiamiMiamiFlorida33137
Adam W Carrico, PhD
[email protected]
(305) 348-7887

Find similar trials in Coral Gables, FL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Miami Neuroimaging Facility· Coral Gables, FLCare Resource - Midtown Miami· Miami, FL

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