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

Trial Summary

What is the purpose of this trial?

Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes. Randomized clinical trials (RCTs) of alcohol interventions for people with HIV (PWH) have had limited success, perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH. This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems. One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance (EA)- i.e., repeated, and maladaptive, use of substances and/or other behaviors to escape or avoid unwanted thoughts, feelings, and/or urges. Acceptance and commitment therapy (ACT) targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes; however there have not been any full-scale RCTs of ACT for alcohol use among any population, including PWH. The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation, into an intervention for PWH who drink at unhealthy levels (NIH/NIAAA; R34AA026246). This six-session, telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team. The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who drink at unhealthy levels. The specific aims are: To determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH (Aim 1) and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes (Aim 2). The investigators will accomplish these aims by: conducting a remote, RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed (n = 150), or a BI intervention (n = 150) previously shown to reduce alcohol use among PWH. The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes, measured at all timepoints.

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.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for alcohol consumption in people with HIV?

ACT has been shown to help reduce alcohol use and improve mental health in people with alcohol use disorder and other mental health conditions. In studies, ACT has been effective in reducing drinking and cravings, and improving depression and anxiety symptoms, which suggests it could be beneficial for people with HIV who struggle with alcohol use. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for people with HIV and alcohol use issues?

ACT is generally considered safe for people with HIV and alcohol use issues, as studies have shown it to be acceptable and well-received by participants. It focuses on improving mental health and coping strategies without significant safety concerns reported. ^{1 3 4 5 6}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for alcohol consumption in people with HIV?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping individuals accept their thoughts and feelings rather than trying to change them, and it encourages commitment to personal values to guide behavior. This approach is particularly beneficial for people with HIV who face multiple mental health and substance-related challenges, as it addresses core processes common to these issues. ^{1 2 3 4 7}

Eligibility Criteria

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

I am 18 or older and receiving HIV treatment.

Reading at an 8th grade level

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. [2023]

2. England 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. [2018]

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

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. [2022]

4. Switzerland 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. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

The Use of Acceptance and Commitment Therapy in Substance Use Disorders: A Review of Literature. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. [2019]

7. England 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. [2015]