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Cognitive Behavioral Therapy for Depression in HIV (TRIDENT Trial)

N/A
Recruiting
Led By Adam W Carrico, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Verified HIV+ status with antiretroviral medications bearing his/her name
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

TRIDENT Trial Summary

This trial will test if a psychological treatment for depression can also help improve the gut microbiome, immune system, and brain functioning in people living with HIV.

Who is the study for?
This trial is for adults over 18 with HIV, depression, and an undetectable viral load. They must be able to undergo fMRI scans (no metal implants/pacemakers), have a BMI under 40, stable antidepressant use if applicable, and elevated CRP levels. Pregnant individuals or those who've had recent CBT for depression are excluded.Check my eligibility
What is being tested?
The TRIDENT study tests how cognitive-behavioral therapy aimed at improving adherence to antiretroviral therapy and managing depression affects the gut microbiome, immune response, and brain function in people living with HIV.See study design
What are the potential side effects?
While not drug-related, potential side effects from participating may include discomfort during psychological treatment sessions or stress from discussing personal issues. The fMRI scan is generally safe but can cause claustrophobia or anxiety.

TRIDENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am HIV positive and on antiretroviral therapy.
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I can undergo fMRI scans without issues related to claustrophobia, metal implants, pacemakers, and my BMI is under 40.
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I have been diagnosed with Major Depressive Disorder.

TRIDENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in connectivity of the negative valence system
Change in resting state activation of the negative valence system
Secondary outcome measures
Alterations in gut microbiota
Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway
Depressive Symptoms
+4 more

TRIDENT Trial Design

2Treatment groups
Experimental Treatment
Group I: Wait-List Control (WLC)Experimental Treatment2 Interventions
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.
Group II: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)Experimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,405 Total Patients Enrolled
3 Trials studying Depression
170 Patients Enrolled for Depression
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,926 Total Patients Enrolled
29 Trials studying Depression
10,112 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,549 Total Patients Enrolled
666 Trials studying Depression
251,434 Patients Enrolled for Depression

Media Library

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) Clinical Trial Eligibility Overview. Trial Name: NCT05136703 — N/A
Depression Research Study Groups: Wait-List Control (WLC), Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)
Depression Clinical Trial 2023: Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) Highlights & Side Effects. Trial Name: NCT05136703 — N/A
Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05136703 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05136703 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial actively seeking participants at the present moment?

"Affirmative. According to the data found on clinicaltrials.gov, this medical experiment is actively enrolling participants after having been first posted on August 30th 2022 and last revised September 7th 2022. A total of 150 patients are required from 1 research site."

Answered by AI

How many participants are being enlisted in this research project?

"Affirmative. Clinicaltrials.gov evidences that this clinical study, which was initially posted on August 30th 2022, is actively looking for participants. A total of 150 patients need to be enrolled from one medical centre."

Answered by AI

What is the central aim of this clinical experiment?

"Primarily, this clinical trial will quantitatively assess how the negative valence system's connectivity alters over a period of 6 Months. Additionally, Gastrointestinal Dysbiosis (measured through 16s sequencing of rectal swabs and fecal samples), Conserved Transcriptional Response to Adversity leukocyte signalling pathway (examined via Ribonucleic Acid sequencing from peripheral blood mononuclear cells) and Soluble Markers for microbial translocation (assessed with ELISA methods targeting Plasma LBP levels in plasma samples; log10 being the unit of measure)."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried tried other things that didn’t work and I’m looking for treatments that can help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)
Adam Carrico, PhD 2022. "Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136703.
All > Depression Miami
~62 spots leftby Jun 2025
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