← Back to Search

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

Must not have

Received CBT for depression in the past 2 years

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am HIV positive and on antiretroviral therapy.

Select...

I can undergo fMRI scans without issues related to claustrophobia, metal implants, pacemakers, and my BMI is under 40.

Select...

I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone cognitive behavioral therapy for depression within the last 2 years.

Select...

I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in connectivity of the negative valence system

Change in resting state activation of the negative valence system

Secondary study objectives

Alterations in gut microbiota

Conserved transcriptional response to adversity (CTRA) leukocyte signaling pathway

Depressive Symptoms

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 15 individually delivered CBT-AD sessions (12 sessions and 3 booster 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 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.

0 / 6Eligibility criteria met