Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06648629

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

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

300

Participants Needed

1

Research Sites

30 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

This research investigates the impact of Acceptance and Commitment Therapy (ACT) compared to a Brief Alcohol Intervention (BI) on reducing unhealthy alcohol use and related mental health symptoms in adults living with HIV who drink at risky levels. Unhealthy alcohol consumption significantly affects HIV treatment outcomes, and previous trials have had limited success, possibly due to co-occurring mental health issues. The study aims to evaluate if ACT, a therapy targeting experiential avoidance, can improve alcohol use and psychological outcomes in this population. Participants will be randomly assigned to receive either six weekly 30-45 minute telephone sessions of ACT, which uses mindfulness and values-guided behavior to reduce avoidance and improve acceptance, or a BI consisting of two 30-60 minute telephone sessions, two 5-10 minute booster calls, and two 5-minute reminder calls. The interventions are delivered remotely, and the study monitors effects over time with assessments at baseline, post-treatment (7 weeks), and at 3, 6, and 12 months post-randomization. During the study, participants complete self-reports and biomarker tests measuring alcohol use frequency, quantity, and phosphatidylethanol levels. Psychological symptoms such as depression, anxiety, stress, and experiential avoidance are also evaluated at multiple time points. The study involves 300 adults with HIV drinking at unhealthy levels, focusing on if ACT reduces alcohol use and mental health symptoms better than BI. The total participation includes treatment and follow-up assessments lasting up to a year.

CONDITIONS

Brief 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 AUDIT-C scores over the previous 3 months (score of 64 men or 63 women)
  • Currently on HIV treatment
  • 18 years or older
  • Able to 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 of 12 or higher
  • Severe depression indicated by PHQ-9 score of 20 or higher
  • Severe anxiety indicated by GAD-7 score of 15 or higher
  • Participants who screen out will be referred for mental health treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote)

Treatment

Duration - Approximately 7 weeks

Participants receive either a six-session, weekly Acceptance and Commitment Therapy (ACT) delivered via telephone, or a Brief Alcohol Intervention consisting of two sessions plus booster and reminder calls.

6 weekly telephone sessions for ACT or 2 telephone sessions plus 4 booster/reminder calls for BI

Follow-up

Duration - Up to 12 months post-treatment

Participants are assessed for alcohol use and psychological symptoms at multiple points after treatment ends.

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

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

S

Stephen A Maisto, PhD

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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Published Research Related To This Trial

Acceptance and commitment therapy for people with HIV who drink at unhealthy levels: Protocol for the ACCEPT randomized controlled trial.

Sarah E Woolf-King, Emily Presutti, Olivia McKenna...

https://pubmed.ncbi.nlm.nih.gov/41326267