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NCT05136703 | Recruiting | Depression


Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Sponsor:

Florida International University

Information provided by (Responsible Party):

Adam Carrico, PhD

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.

Condition or disease

Depression

HIV-1-infection

Inflammation

Intervention/treatment

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

Antiretroviral Therapy (ART) Adherence Counseling

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking : Single
Primary Purpose : Other
Official Title : Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : October 31, 2025
Arm Intervention/treatment

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

Participants randomized to receive CBT-AD immediately will complete up to 12 individual 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

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 12 individually delivered CBT-AD sessions focused on depression.

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

Behavioral: Antiretroviral Therapy (ART) Adherence Counseling

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 17 or greater
  • If prescribed antidepressants, on a stable regimen and dose for at least 2 months
  • C-Reactive Protein (CRP) of 1 mg/L or greater
  • 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
  • Otherwise eligible but does not complete baseline biospecimen collection and fMRI visit

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

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Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Florida

University of Miami

Miami, florida, United States, 33136

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