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/Actively Recruiting
Led by Syracuse University · Updated on 2026-02-04
300
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
S
Sarah E Woolf-King, PhD
S
Stephen A Maisto, PhD
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Syracuse University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | ACT (experimental) | BI (active comparator) | WHO brief intervention (current care context) |
|---|---|---|---|
| What it is | A trans‑diagnostic behavioral treatment using mindfulness and values‑based action to reduce experiential avoidance in people living with HIV who drink at unhealthy levels. | A standard brief alcohol intervention involving drinking agreements, self‑monitoring diaries, mood/situational discussion, and coping strategies to reduce hazardous drinking in people with HIV. | A brief intervention framework involving personalized feedback, strategies to manage high‑risk situations, and encouragement to reduce drinking as recommended by WHO. |
| Role in trial | Investigational behavioral therapy being studied against active comparator. | Active comparator behavioral intervention implemented in trial. | Represents widely used current‑care brief alcohol intervention. |
| Primary use | To reduce hazardous alcohol drinking and related psychological symptoms by targeting experiential avoidance. | To decrease alcohol use among people with HIV through brief counseling components. | To provide brief counseling that helps people cut back on risky drinking levels. |
| How it is given or performed | Delivered remotely via a six‑session telephone‑based behavioral therapy protocol. | Delivered as the behavioral standard brief intervention including diaries and discussion over unspecified modality in trial. | Usually delivered in primary care in one or two brief sessions with feedback and planning. |
| Evidence status | Efficacy is under investigation in a randomized trial; preliminary feasibility data exist. | Evidence supports BI reduces hazardous drinking in people with HIV. | Strong evidence from WHO and international studies supports BI effectiveness in reducing hazardous alcohol use. |
| Important risks | No specific risks stated; behavioral therapy is non‑invasive. | No specific risks stated; brief intervention is non‑invasive behavioral therapy. | Behavioral brief intervention is non‑invasive and considered safe. |
| Important limitations | Effectiveness is not yet known; remote delivery may limit engagement reliability. | Previous BI findings in HIV may be limited to specific formats or populations, and generalizability to remote settings is uncertain. | WHO BI recommendations are broadly applied but may not reflect effectiveness in HIV‑specific or remote trial settings. |
| Patient impact | Under study; outcomes not yet reported. | Prior BI reduced drinking frequency among HIV‑infected individuals. | BI is associated with reduced hazardous drinking and related health risk in general populations. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sarah E Woolf-King, Emily Presutti, Olivia McKenna...
https://pubmed.ncbi.nlm.nih.gov/41326267/Syracuse University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor