Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

NCT06648629 | Recruiting DMC

• 2 other identifiers: 23-207R01AA030935
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection; Alcohol Drinking

Keywords

HIV; Alcohol; ACT; Treatment

Outcome Measures

Primary Outcomes (3)

• Alcohol use - Frequency

  The Timeline Followback will be used to estimate the Number of Drinking Days 30 days prior to study visit appointment

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Alcohol Use - Quantity

  The Timeline Followback will be used to estimate the Number of Drinks per Drinking Day 30 days prior to study visit appointment

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Phosphatidylethanol (PEth)

  PEth is a metabolite, formed only in the presence of alcohol use and detectable in dried blood spots for approximately 3-4 weeks. The investigators will use both absolute PEth values and a cutoff of 50 mg/ml to indicate recent unhealthy alcohol use. Based on the consideration of both prevalence of underreport in the sample, the investigators will also consider using a compound measure of PEth+ (PEth ≥50ng/ml) and/or self-reported Alcohol Quantity \& Frequency via the AUDIT-C+ (≥4, men; ≥3, women) for any unhealthy alcohol use in the last 21 days as an outcome of interest.

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Secondary Outcomes (5)

• Symptoms of Anxiety

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Symptoms of Depression

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Self-reported levels of Stress

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Biological levels of Stress

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Symptoms of Experiential Avoidance

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Other Outcomes (3)

• Alcohol-related Problems

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Adherence to HIV Medications

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

• Functional Impairment

  Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Participants randomized to the ACT arm will receive six, weekly, 30-45-minute ACT intervention sessions delivered via telephone.

Behavioral: Acceptance and Commitment Therapy (ACT)

Brief Alcohol Intervention (BI)

ACTIVE COMPARATOR

Participants randomized to BI will receive two 30-60 minute sessions of a brief alcohol intervention delivered via telephone, two 5-10-minute booster calls, and two 5-minute reminder phone calls.

Behavioral: Brief Alcohol Intervention

Interventions

Brief Alcohol Intervention BEHAVIORAL

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.

Also known as: BI

Brief Alcohol Intervention (BI)

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

Also known as: ACT

Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with HIV
• Drink at unhealthy levels based on self-reported answers to the AUDIT-C, referencing drinking over the previous 3 months \[score of ≥4 (men) or ≥3 (women) will be used to identify eligible participants\]
• on HIV treatment and are
• years or older.
• Read at an 8th grade level
• Can provide a physical address
• Able to provide informed consent

You may not qualify if:

• Anyone with a score = 12 on the AUDIT-C will be excluded.
• Anyone with a score ≥20 on the PHQ-9, indicative of severe depression, will be excluded.
• Anyone with a score of ≥15 on the GAD-7, indicative of severe anxiety, will be excluded.
• Referrals for mental health treatment will be given to all participants who screen out.

Sponsors & Collaborators

• Syracuse University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of Rochester: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

RECRUITING

Related Publications (1)

• Woolf-King SE, Presutti E, McKenna O, Hahn JA, Abar B, Dahne J, Gump BB, Bendinskas KG, Maisto SA. Acceptance and commitment therapy for people with HIV who drink at unhealthy levels: Protocol for the ACCEPT randomized controlled trial. Contemp Clin Trials. 2025 Dec;159:108130. doi: 10.1016/j.cct.2025.108130. Epub 2025 Oct 24.

  PMID: 41326267 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Acceptance and Commitment Therapy; Ethanol; Methods

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Alcohols; Organic Chemicals; Investigative Techniques

Central Study Contacts

Sarah E Woolf-King, PhD

CONTACT

314-443-2354; sewoolf@syr.edu

Stephen A Maisto, PhD

CONTACT

samaisto@syr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators will have a research staff members who are responsible for administering baseline appts (with randomization) and post-treatment study appointments. The outcome assessor will be blind to intervention condition. Interventionists will not collect any outcome data. Study investigators and the Data Safety Monitoring Board (DSMB) members will be presented with interim data (e.g., study completion reports) that are blinded to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of the following two pre-specified treatment groups: Acceptance and Commitment Therapy or Brief Alcohol Intervention.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: October 18, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will share data in accordance with the default NIAAADA data sharing schedule in accordance with the applicable Data Sharing Terms and Conditions of award.

Locations

US (1)