Acceptance and Commitment Therapy for Alcohol Consumption in People with HIV

Overseen By Stephen A Maisto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Syracuse University

Disqualifiers: Severe depression, severe anxiety, others

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

Compensation: Varies

Number of Visits: 9

Duration: 7 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Acceptance and Commitment Therapy (ACT), a type of talking therapy, can help people living with HIV reduce alcohol use and improve mental health. Participants will receive either ACT sessions or a different brief alcohol intervention over the phone. The goal is to identify which approach more effectively lowers alcohol consumption and eases symptoms like depression and anxiety. Suitable participants should be living with HIV and consuming alcohol at unhealthy levels. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance mental health support for people with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on alcohol use and mental health, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy (ACT) has been well-received in past studies for treating substance use problems. Three detailed reviews found that ACT improves treatment results, suggesting it is generally safe. In studies focused on alcohol use, ACT proved practical and acceptable, meaning participants found it easy to handle and agreeable. This is a positive indicator for safety.

It is important to note that this trial tests a therapy method, not a new drug, which typically results in fewer side effects. However, since ACT has not been tested in large trials specifically for alcohol use in people with HIV, extensive safety data from large groups is lacking. For those considering joining this trial, these early findings are encouraging, but the therapy's specific effects on alcohol use in this group are still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for reducing alcohol consumption in people with HIV because it offers a unique psychological approach. Unlike traditional treatments that focus primarily on reducing alcohol intake through medication or conventional counseling, ACT emphasizes mindfulness and acceptance strategies to help individuals manage their thoughts and emotions related to alcohol use. This method is delivered conveniently via telephone, making it accessible and flexible for participants. The innovative use of psychological techniques in ACT aims to empower individuals with HIV to better control their alcohol consumption, potentially leading to improved overall health outcomes.

What evidence suggests that Acceptance and Commitment Therapy could be an effective treatment for alcohol consumption in people with HIV?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive, can help reduce unhealthy alcohol use. Studies have found that ACT leads to higher abstinence rates compared to other therapies, such as Cognitive Behavioral Therapy (CBT). ACT addresses the tendency to avoid difficult thoughts and feelings, which often leads to alcohol use as an escape. By tackling this issue, ACT supports healthier decision-making. For people with HIV, reducing alcohol consumption is important because it can improve overall treatment outcomes. Although large-scale trials specifically for alcohol use in people with HIV have not been conducted, positive outcomes in other groups suggest that ACT could be effective for them as well. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adult individuals living with HIV who drink alcohol at unhealthy levels. Participants must be willing to undergo therapy sessions over the phone and provide self-reports on their drinking habits, as well as other psychological and functional outcomes.

Inclusion Criteria

Living with HIV

Reading at an 8th grade level

I am 18 or older and receiving HIV treatment.

Exclusion Criteria

Score = 12 on the AUDIT-C

Score ≥20 on the PHQ-9 indicative of severe depression

Score of ≥15 on the GAD-7 indicative of severe anxiety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ACT intervention or the BI intervention delivered via telephone

7 weeks

6 sessions (ACT) or 2 sessions + booster calls (BI)

Follow-up

Participants are monitored for alcohol use, anxiety, depression, stress, and other outcomes

12 months

Assessments at 3, 6, and 12 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy (ACT)

Trial Overview The study tests if Acceptance and Commitment Therapy (ACT) can reduce alcohol use and improve mental health among people with HIV compared to a Brief Alcohol Intervention (BI). It's a randomized trial where participants are assigned by chance to one of these two treatments.

How Is the Trial Designed?

Group I: Acceptance and Commitment Therapy (ACT) Experimental Treatment 1 Intervention

Participants randomized to the ACT arm will receive six, weekly, 30-45-minute ACT intervention sessions delivered via telephone.

Group II: Brief Alcohol Intervention (BI) Active Control 1 Intervention

Participants randomized to BI will receive two 30-60 minute sessions of a brief alcohol intervention delivered via telephone, two 5-10-minute booster calls, and two 5-minute reminder phone calls.

Who Is Running the Clinical Trial?

Syracuse University

Lead Sponsor

Trials

54

Recruited

118,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Published Research Related to This Trial

A new Acceptance and Commitment Therapy (ACT)-based intervention was developed for hospitalized patients with HIV who are not consistently engaged in care, showing high acceptability among participants.

Of the patients who attended at least three sessions, half followed up with HIV care and achieved a viral load of less than 20 copies/mL two months after the intervention, indicating potential efficacy in improving treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. Dindo, L., Moitra, E., Roddy, MK., et al.[2023]

Acceptance and Commitment Therapy (ACT) has been shown to effectively reduce substance use and promote abstinence in individuals with substance use disorders (SUD), based on a review of literature from 2011 to 2020.

The review indicates that ACT can be successful both as a standalone treatment and when combined with other therapeutic approaches, highlighting its versatility in managing SUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Acceptance and Commitment Therapy in Substance Use Disorders: A Review of Literature. Osaji, J., Ojimba, C., Ahmed, S.[2022]

This study adapted an Acceptance and Commitment Therapy (ACT) intervention for people living with HIV who engage in hazardous drinking, using a systematic approach that included input from both patients (13 participants) and healthcare providers (10 participants).

The adaptation process followed the ADAPT-ITT model, which provides a structured framework for developing behavioral interventions, ensuring that the new ACT intervention is tailored to the specific needs of PWH and can be effectively implemented in future randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. Woolf-King, SE., Firkey, M., Foley, JD., et al.[2022]

Acceptance and Commitment Therapy (ACT) significantly improved cumulative abstinence duration and reduced depression and anxiety symptoms in patients with alcohol use disorder (AUD) and comorbid affective disorders compared to treatment as usual (TAU) alone, based on a study of 52 participants.

The benefits of ACT were sustained over a 6-month follow-up period, indicating its effectiveness as an adjunct to standard treatment for enhancing recovery outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy in the Treatment of Alcohol Use Disorder and Comorbid Affective Disorder: A Pilot Matched Control Trial. Thekiso, TB., Murphy, P., Milnes, J., et al.[2018]

In a study of 2340 HIV-infected patients on highly active antiretroviral therapy (HAART), harmful alcohol consumption (HAC) was found to be prevalent, with rates of 12% based on CAGE scores, 27% using AUDIT-C, and 9% reporting regular binge drinking.

Certain groups, particularly men who have sex with men using stimulants, polydrug users, and ex-drug users, were identified as being at higher risk for HAC, highlighting the need for targeted interventions to reduce alcohol consumption and improve treatment adherence in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmful alcohol consumption and patterns of substance use in HIV-infected patients receiving antiretrovirals (ANRS-EN12-VESPA Study): relevance for clinical management and intervention. Michel, L., Carrieri, MP., Fugon, L., et al.[2015]

Acceptance and Commitment Therapy (ACT) effectively enhances psychological flexibility and has shown efficacy in treating a variety of psychiatric disorders, including depression, anxiety, and PTSD, with a meta-analysis revealing an average effect size of 0.66 at post-treatment across 704 participants.

ACT not only improves mental health outcomes but also benefits other medical areas such as chronic pain management and smoking cessation, demonstrating its versatility and positive impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. Ducasse, D., Fond, G.[2019]

Acceptance and Commitment Therapy (ACT) was found to be perceived as appropriate and relevant for people living with HIV who also engage in hazardous drinking, suggesting its potential as a tailored intervention.

Participants expressed both satisfaction and dissatisfaction with ACT, highlighting the need to address specific positive and negative effects, as well as identifying facilitators and barriers to effectively implementing this therapy in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. Woolf-King, SE., Sheinfil, AZ., Babowich, JD., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6764523/

Acceptance and Commitment Therapy (ACT) for HIV ... The purpose of this qualitative study was to collect preliminary data on the practical feasibility and acceptability of Acceptance and Commitment Therapy (ACT) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425003246

Protocol for the ACCEPT randomized controlled trial Alcohol consumption at unhealthy levels is associated with negative consequences at nearly every step of the HIV care continuum. We describe ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06648629

Acceptance and Commitment Therapy for HIV+ Hazardous ... Study Overview. Brief Summary. Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes.

4. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=5396702

Acceptance and Commitment Therapy for People with HIV ... Background: Alcohol consumption at unhealthy levels is associated with negative consequences at nearly every step of the HIV care continuum.

5. sciencedirect.com sciencedirect.com/science/article/pii/S221214472400053X

Effectiveness of acceptance and commitment therapy for ... ACT demonstrated higher abstinence rates than CBT conditions at EOT (p = 0.002). A lower age increased abstinence rates in the short (p = 0.004) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03974061

Brief Acceptance and Commitment Therapy for HIV ... No alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for ...

7. link.springer.com link.springer.com/article/10.1007/s10461-022-03649-x

Development of a Telephone-Delivered Acceptance and ... Hazardous alcohol consumption is thus a critical factor in HIV treatment that significantly contributes to poorer HIV treatment-related ...