Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
NCT ID: NCT05136703
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2022-08-30
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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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.
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
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
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
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.
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
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
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
Interventions
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Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
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
This treatment involves a single session integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
Eligibility Criteria
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Inclusion Criteria
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
2. Active, untreated major mental illness
3. Pregnancy at baseline
4. Received CBT for depression in the past 2 years
5. 5\. Otherwise eligible but does not complete the run-in period that includes the baseline assessment, biospecimen collection, the fMRI visit, and a separately scheduled randomization visit
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Florida International University
OTHER
Responsible Party
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Adam Carrico, PhD
Professor
Principal Investigators
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Adam W Carrico, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida International University
Locations
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University of Miami Neuroimaging Facility
Coral Gables, Florida, United States
Care Resource - Midtown Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20210773
Identifier Type: -
Identifier Source: org_study_id
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