Cognitive Behavioral Therapy for Depression in HIV

(TRIDENT Trial)

Recruiting at 2 trial locations

Overseen By Adam W Carrico, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must be taking: Antiretrovirals

Disqualifiers: Untreated mental illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 4 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on antidepressants, you must have been on a stable dose for at least 2 months before joining the trial.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in people living with HIV?

Research shows that Cognitive Behavioral Therapy (CBT) is effective in reducing depression in people living with HIV, with better results over the long term. However, while CBT helps with depression, its impact on improving medication adherence is not statistically significant. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Depression in HIV safe for humans?

Cognitive Behavioral Therapy (CBT) for depression in people living with HIV has been studied and is generally considered safe. It is used to improve depressive symptoms and medication adherence, and no significant safety concerns have been reported in the research. ^{1 2 3 4 5}

How is the treatment Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) unique for treating depression in people with HIV?

CBT-AD is unique because it combines cognitive behavioral therapy (CBT) techniques to address both depression and medication adherence specifically for people living with HIV. This dual focus helps improve mental health and ensures patients stick to their antiretroviral therapy, which is crucial for managing HIV effectively. ^{1 2 3 4 5}

Research Team

Adam W Carrico, PhD

Principal Investigator

Florida International University

Eligibility Criteria

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.

Inclusion Criteria

I have been on the same antidepressant dose for at least 2 months.

Suppressed HIV viral load (< 200 copies/mL)

I am 18 years old or older.

Exclusion Criteria

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

I am unable to understand or sign the consent form.

Otherwise eligible but does not complete baseline biospecimen collection and fMRI visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) with up to 15 individual sessions over four months

4 months

15 sessions (in-person)

Wait-List Control

Participants in the wait-list control group receive ART adherence counseling and have the opportunity to receive CBT-AD after six months

6 months

1 session (in-person) initially, followed by 15 sessions (in-person) after 6 months

Follow-up

Participants are monitored for changes in depressive symptoms, gut microbiota, and immune markers

6 months

Treatment Details

Interventions

• Antiretroviral Therapy (ART) Adherence Counseling
• Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD)

Trial Overview 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.

Participant Groups

Group I: Wait-List Control (WLC) Experimental Treatment 2 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 Treatment 2 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.

Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive-Behavioral Therapy for:

• Depression
• Anxiety disorders
• Substance use disorders
• Eating disorders
• Sleep disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Eating disorders

Approved in Canada as Cognitive-Behavioral Therapy for:

• Depression
• Anxiety disorders
• Substance use disorders
• Eating disorders
• Sleep disorders

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Cognitive Behavioral Therapy for adherence and depression (CBT-AD) has been shown to effectively improve both depressive symptoms and medication adherence in HIV-infected adults, addressing a critical need given the high rates of depression in this population.

The article provides practical resources, including video demonstrations and treatment guides, to help therapists implement CBT-AD, highlighting adaptations necessary for treating HIV-infected individuals compared to those without HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and Demonstration of Cognitive Behavioral Therapy to Enhance Antiretroviral Therapy Adherence and Treat Depression in HIV-Infected Adults. Newcomb, ME., Bedoya, CA., Blashill, AJ., et al.[2020]

Cognitive behavioral therapy for adherence and depression (CBT-AD) significantly improved treatment adherence and reduced depression symptoms in HIV patients undergoing substance abuse treatment, as shown in a randomized controlled trial with 89 participants.

While the benefits in depression were maintained after treatment, adherence improvements were not sustained, indicating the need for ongoing adherence support to ensure long-term treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. Safren, SA., O'Cleirigh, CM., Bullis, JR., et al.[2022]

Cognitive behavioral therapy for adherence and depression (CBT-AD) delivered by a trained nurse significantly improved depression scores in people living with HIV, with participants showing a reduction in the Beck Depression Inventory score from 33.0 to 13.4 after 12 sessions, and maintaining improvement at 8 months follow-up.

The study suggests that nurse-delivered CBT-AD is feasible and acceptable, with participants also reporting improvements in quality of life, indicating that this approach could help expand access to mental health support for PLWH in settings where clinical psychologists are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression of People Living with HIV in Korea. Kim, JH., Kim, JM., Ye, M., et al.[2023]

In a study involving HIV-positive adults with depression, integrating cognitive behavioral therapy (CBT) with adherence counseling (CBT-AD) significantly improved both antiretroviral therapy (ART) adherence and depression symptoms compared to enhanced treatment as usual (ETAU).

Patients receiving CBT-AD showed a 1.00 percentage point increase in adherence per visit and significant reductions in depression scores, with no reported adverse events, highlighting the safety and efficacy of this combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. Safren, SA., Bedoya, CA., O'Cleirigh, C., et al.[2018]

Cognitive Behavioral Therapy (CBT) significantly improves depressive symptoms in people living with HIV, with a greater effect observed in the long term (over 6 months) compared to the short term (0-6 months), based on a meta-analysis of 16 studies involving 1,998 patients.

However, CBT did not show a statistically significant improvement in adherence to antiretroviral therapy (ART) compared to control groups, indicating that while it helps with depression, it may not directly enhance medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy on improving depressive symptoms and increasing adherence to antiretroviral medication in people with HIV. Qin, K., Zeng, J., Liu, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Description and Demonstration of Cognitive Behavioral Therapy to Enhance Antiretroviral Therapy Adherence and Treat Depression in HIV-Infected Adults. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of a Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression of People Living with HIV in Korea. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy on improving depressive symptoms and increasing adherence to antiretroviral medication in people with HIV. [2022]