Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06648629

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Led by Syracuse University · Updated on 2026-02-04

300

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

Sponsors

S

Syracuse University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Living with HIV
  • Drink at unhealthy levels based on self-reported answers to the AUDIT-C from the past 3 months (score of 64 for men or 63 for women)
  • Currently on HIV treatment
  • 18 years or older
  • Can read at an 8th grade level
  • Can provide a physical address
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • AUDIT-C score equal to 12
  • PHQ-9 score of 20 or higher indicating severe depression
  • GAD-7 score of 15 or higher indicating severe anxiety
  • Participants who screen out will be referred for mental health treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Syracuse University

Syracuse, New York, United States, 13244

Actively Recruiting

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Research Team

S

Sarah E Woolf-King, PhD

CONTACT

S

Stephen A Maisto, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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