Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
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
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
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