RecruitingNot ApplicableNCT06648629

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: A Randomized Clinical Trial


Sponsor

Syracuse University

Enrollment

300 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing Acceptance and Commitment Therapy (ACT) — a type of talk therapy that helps people change their relationship with difficult thoughts and feelings — to help people living with HIV who are drinking alcohol at unhealthy levels reduce their drinking. **You may be eligible if...** - You are 18 or older - You are living with HIV - You are on HIV treatment - You drink at unhealthy levels (score of 4+ for men or 3+ for women on a standard alcohol screening tool) - You can read at an 8th-grade level - You have a physical address **You may NOT be eligible if...** - Your alcohol use score is at the highest possible level (12 on the AUDIT-C) - You have severe depression (score ≥20 on PHQ-9) - You have severe anxiety (score ≥15 on GAD-7) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance and Commitment Therapy (ACT)

ACT is a trans-diagnostic treatment that targets experiential avoidance as an underlying factor common to mental and behavioral health problems. Mindfulness skills and values-guided behavioral action plans are used to decrease experiential avoidance and impact a broad array of psychological symptoms via improved psychological acceptance.

BEHAVIORALBrief Alcohol Intervention

The Brief Alcohol Intervention (BI) is a standard intervention for reducing alcohol use in PWH. The BI includes the creation of a drinking agreement, self-monitoring via drinking diary cards, discussion of risky moods/situation, and strategies for managing these moods/situations.


Locations(1)

Syracuse University

Syracuse, New York, United States

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NCT06648629


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