Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers

Part of paid clinical trials in Syracuse, New York.

Sponsor
Syracuse University
Study ID
NCT06648629
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 22, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Alcohol use - Frequency [ Time Frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syracuse UniversitySyracuseNew York13244
Sarah E Woolf-King, PhD
[email protected]
315-443-9917
Stephen A Maisto, PhD
[email protected]
315.443.2334

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