Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Florida International University (FIU)

Status: Enrolling

Conditions: Inflammation; HIV-1-infection; Depression

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05136703

20210773

R01MH128868 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 clinical interview (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., no claustrophobia, no metal implants, no pacemaker, and BMI < 40)

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 fMRI visit

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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150 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Antiretroviral Therapy (ART) Adherence Counseling

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

Wait-List Control (WLC)

Experimental group

Description:

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.

Treatment:

Behavioral: Antiretroviral Therapy (ART) Adherence Counseling

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