Florida International University
Adam Carrico, PhD
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.
Depression
HIV-1-infection
Inflammation
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
Antiretroviral Therapy (ART) Adherence Counseling
Not Applicable
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 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Miami
Miami, florida, United States, 33136