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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how Cognitive-Behavioral Therapy (CBT) affects the gut, immune system, and brain in individuals with HIV who also experience depression. The trial includes two groups: one begins therapy immediately, while the other starts after a six-month delay. It seeks participants who have HIV, are managing depression, and are on stable treatment for both. Participants must be able to undergo a brain scan and should not have received similar therapy recently. As an unphased trial, this study provides a unique opportunity to contribute to understanding how CBT can enhance mental and physical health in people 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 prior data suggests that this cognitive-behavioral treatment is safe for people living with HIV?

Research has shown that Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) is generally safe for individuals with HIV and depression. This therapy not only improves mental health but also enhances adherence to HIV treatment plans.

Studies suggest that individuals tolerate CBT-AD well, with few reports of negative effects. As a form of talk therapy, it involves no medication or physical procedures, typically resulting in fewer risks. Participants have completed numerous sessions without major safety concerns.

Overall, CBT-AD appears to be a safe and effective option for managing depression and improving treatment adherence in people living with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) because it offers a dual-focused approach that specifically targets both depression and medication adherence in individuals with HIV. Unlike standard treatments that may address either mental health or adherence separately, CBT-AD integrates these concerns, aiming to improve both psychological well-being and adherence to antiretroviral therapy (ART). This holistic method not only addresses the emotional challenges but also supports consistent medication use, which is crucial for effective HIV management. By focusing on these interconnected issues, CBT-AD has the potential to enhance overall treatment outcomes for people living with HIV.

What evidence suggests that Cognitive-Behavioral Therapy for Adherence and Depression might be an effective treatment for depression in people living with HIV?

Research has shown that Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD), which participants in this trial may receive, effectively treats depression in people with HIV. Studies have found that CBT-AD helps patients adhere to their HIV medication regimens. This therapy also significantly reduces symptoms of depression, with better long-term results compared to short-term ones. CBT-AD combines methods to manage depression with techniques to support medication adherence. Overall, previous trials have shown that the therapy is well-received and offers promising results for those dealing with both HIV and depression. ^{1 2 3 6 7}

Who Is on the Research Team?

Adam W Carrico, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

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 HIV positive and on antiretroviral therapy.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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) 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3365619/

Cognitive Behavioral Therapy for Adherence and ...

The present study tested cognitive-behavioral therapy for adherence and depression (CBT-AD) in patients with HIV and depression in active substance abuse ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22545737/

Cognitive behavioral therapy for adherence and depression ...

Results: At post-treatment, the CBT-AD condition showed significantly greater improvement than ETAU in MEMS (electronic pill cap) based adherence, γslope = ...

3.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06109610

Cognitive Behavioral Therapy on Adherence and ...

Cognitive behavioral therapy may solve these problem. Detailed Description. Depression is highly comorbid with HIV/ AIDS and is associated with worse poor ...

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.990994/full

Effects of cognitive behavioral therapy on improving ...

Cognitive behavioral therapy is effective in improving depressive symptoms in people living with HIV, with better long-term (>6 months) results than short-term ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2352301816300534

Articles Cognitive behavioural therapy for adherence and ...

Integrating evidenced-based treatment for depression with evidenced-based adherence counselling is helpful for individuals living with HIV/AIDS and depression.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032723011849

“Trajectories of treatment response in a cognitive ...

CBT-AD has been shown to be effective at reducing both MDD and key chronic disease outcomes in HIV, including improved ART adherence and viral ...

7.

researchprotocols.org

researchprotocols.org/2020/2/e14200/

Nurse-Delivered Cognitive Behavioral Therapy for ...

Objective: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence ...