Recruiting

Acceptance and Commitment Therapy

Sponsor:

Syracuse University

Code:

NCT06648629

Conditions

HIV-1-infection

Alcohol Drinking

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy (ACT)

Brief Alcohol Intervention

Study Details

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

Study ID

NCT06648629

Start date

Jan 22, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 18 years or older.
  • Read at an 8th grade level
  • Can provide a physical address
  • Able to provide informed consent

Exclusion Criteria:

  • 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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance and Commitment Therapy (ACT)

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

active comparator: Brief Alcohol Intervention (BI)

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.

Interventions

Acceptance and Commitment Therapy (ACT)

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.

Brief Alcohol Intervention

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.

Primary outcome measure

  • Alcohol use - Frequency [ Time Frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline ]
  • Alcohol Use - Quantity [ Time Frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline ]
  • Phosphatidylethanol (PEth) [ Time Frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline ]

Central Contacts and Locations

Central contacts

Sarah E Woolf-King, PhD

314-443-2354sewoolf@syr.edu

Stephen A Maisto, PhD

samaisto@syr.edu

Locations

Syracuse University

Recruiting

Syracuse, New York, United States, 13244

Contacts

Sarah E Woolf-King, PhD

315-443-9917sewoolf@syr.edu

Stephen A Maisto, PhD

315.443.2334samaisto@syr.edu

More Information

Sponsor

Syracuse University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • HIV
  • Alcohol
  • ACT
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syracuse University on 2026-02-04.