- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136703
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT) (TRIDENT)
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adam W Carrico, PhD
- Phone Number: 305-243-6947
- Email: a.carrico@miami.edu
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Adam W Carrico, PhD
- Phone Number: 305-243-6947
- Email: a.carrico@miami.edu
-
Principal Investigator:
- Adam W Carrico, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
|
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.
|
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.
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in resting state activation of the negative valence system
Time Frame: 6 Months
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Measured by functional Magnetic Resonance Imaging (fMRI)
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6 Months
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Change in connectivity of the negative valence system
Time Frame: 6 Months
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Measured by functional Magnetic Resonance Imaging (fMRI)
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Symptoms
Time Frame: 6 Months
|
The Hamilton Rating Scale for Depression is an interviewer-administered measure that has a total score ranging from 0-52 with the higher score indicating greater depressive symptoms
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6 Months
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Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway
Time Frame: 4 Months
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Measured using Ribonucleic Acid (RNA) sequencing from peripheral blood mononuclear cells
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4 Months
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Soluble Markers of Microbial Translocation
Time Frame: 4 Months
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Enzyme-linked immunosorbent assay (ELISA) methods will be employed to measure lipopolysaccharide binding protein (LBP) levels in plasma samples.
Log10 will be the unit of measure.
|
4 Months
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Soluble Markers of Immune Activation and Inflammation
Time Frame: 4 Months
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Enzyme-linked immunosorbent assay (ELISA) methods will be employed to measure levels of monocyte activation markers (i.e., soluble CD14, soluble CD163) and pro-inflammatory cytokines (e.g., interleukin, high sensitivity c-reactive protein) in plasma samples.
Log10 will be the unit of measure.
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4 Months
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Soluble Markers of Dysregulated Neurotransmitter Synthesis
Time Frame: 4 Months
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High performance liquid chromatography method with fluorescence will measure mean levels of the kynurenine/tryptophan and phenylalanine/tyrosine ratios in plasma samples.
Log10 will be the unit of measure.
|
4 Months
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Neurocognitive Functioning
Time Frame: 6 Months
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Changes in mean levels of measures indexing executive functioning, attention, and affect regulation assessed in a comprehensive, interviewer-administered neuropsychological assessment battery.
Units will be expressed as standardized scores (i.e., T scores).
|
6 Months
|
Alterations in gut microbiota
Time Frame: 4 months
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Measured via 16s sequencing of the gut microbiome using rectal swabs and fecal samples
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4 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam W Carrico, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210773
- R01MH128868 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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