RECRUITING

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

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Conditions

DepressionHIV-1-infectionInflammationMicrobiomeHIVCBT-ADGutBrain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Quick Facts

Study Start:2022-08-30
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05136703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 or older
  2. 2. Speaks and reads English
  3. 3. Verified HIV+ status with antiretroviral medications bearing his/her name
  4. 4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 17 or greater
  5. 5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months
  6. 6. Suppressed HIV viral load (\< 200 copies/mL)
  7. 7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \< 40)
  1. 1. Unable to provide informed consent
  2. 2. Active, untreated major mental illness
  3. 3. Pregnancy at baseline
  4. 4. Received CBT for depression in the past 2 years
  5. 5. Otherwise eligible but does not complete baseline biospecimen collection and fMRI visit

Contacts and Locations

Study Contact

Adam W Carrico, PhD
CONTACT
(305) 348-7887
acarrico@fiu.edu

Principal Investigator

Adam W Carrico, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Florida International University

  • Adam W Carrico, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Microbiome
  • HIV
  • CBT-AD
  • Gut
  • Brain

Additional Relevant MeSH Terms

  • Depression
  • HIV-1-infection
  • Inflammation