N/A
N=49
Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
Treatment
Bottom Line
View on ClinicalTrials.gov: NCT03974061 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Drinking Days: Baseline (at Baseline) — 26.21; 21.20 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Acceptance and Commitment Therapy (Behavioral); Brief Alcohol Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Syracuse University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinking Days: Baseline (at Baseline) |
26.21; 21.20 | — |
| PRIMARY Number of Drinking Days: Post-Treatment (at 7-weeks Post-baseline) |
4.28; 2.85 | — |
| PRIMARY Number of Drinking Days: 3-months (at 3-months Post-baseline) |
17.35; 12.11 | — |
| PRIMARY Number of Drinking Days: 6-months (at 6-months Post-baseline) |
19; 9.47 | — |
| PRIMARY Number of Drinks Per Drinking Day: Baseline (at Baseline) |
4.55; 3.99 | — |
| PRIMARY Number of Drinks Per Drinking Day: Post-Treatment (at 7-weeks Post-baseline) |
4.28; 2.85 | — |
| PRIMARY Number of Drinks Per Drinking Day: 3-months (at 3-months Post-baseline) |
3.38; 2.69 | — |
| PRIMARY Number of Drinks Per Drinking Day: 6-months (at 6-months Post-baseline) |
3.2; 2.84 | — |
| PRIMARY Alcohol Consumption Measured by Phosphatidylethanol (PEth): Baseline (at Baseline) |
71; 70 | — |
| PRIMARY Alcohol Consumption Measured by Phosphatidylethanol (PEth): 6-months (at 6-months Post-baseline) |
55; 58 | — |
| PRIMARY ART Adherence Measured by Self-Report: Baseline (at Baseline) |
5.17; 5.32 | — |
| PRIMARY ART Adherence Measured by Self-report: Post-treatment (at 7-weeks Post-baseline) |
5.05; 5.5 | — |
| PRIMARY ART Adherence Measured by Self-report: 3-months (at 3-months Post-baseline) |
4.89; 5.21 | — |
| PRIMARY ART Adherence Measured by Self-report: 6-months (at 6-months Post-baseline) |
5.31; 5.5 | — |
| PRIMARY ART Adherence Measured by Hair: Baseline |
— | — |
| PRIMARY ART Adherence Measured by Hair: 6-months (6-months Post-baseline) |
— | — |
| SECONDARY Symptoms of Experiential Avoidance: Baseline (at Baseline) |
47.83; 50.48 | — |
| SECONDARY Symptoms of Experiential Avoidance: 6-months (at 6-months Post-baseline) |
42; 49.65 | — |
| SECONDARY Symptoms of Depression: Baseline (at Baseline) |
14.5; 16.76 | — |
| SECONDARY Symptoms of Depression: 6-months (at 6-months Post-baseline) |
12.38; 13.85 | — |
| SECONDARY Symptoms of Anxiety: Baseline (at Baseline) |
11.96; 13.04 | — |
| SECONDARY Symptoms of Anxiety: 6-months (at 6-months Post-baseline) |
8.6; 11.5 | — |
| SECONDARY Number of Days Other Substances Used: Baseline (at Baseline) |
16.17; 7.6 | — |
| SECONDARY Number of Days Other Substances Used: 6-months (6-months Post-baseline) |
13.38; 7.1 | — |
Summary
Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for people living with HIV (PLWH) in the United States (US) have shown mixed results, and no alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., comorbid mental health conditions, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, making it a promising approach for hazardous drinkers. The overall objective of this application is to adapt an existing brief ACT intervention developed for smoking cessation, and pilot test its feasibility and acceptability for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will be preliminarily associated with decreased alcohol use, improved ART adherence, decreased symptoms of depression, anxiety, and drug use, and increased acceptance-a known mechanism of change in ACT.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age,
- HIV-positive,
- currently prescribed ART medication,
- score of ≥4 (men) or ≥3 (women) on the AUDIT-C.
Exclusion Criteria
- Experiencing acute illness or declining health status when it is determined by a treatment provider that research participation is contraindicated,
- unable to understand spoken English,
- does not own a cell phone,
- a score of 12 on the AUDIT-C, indicating high risk for a severe alcohol use disorder,
- a score of ≥20 on the PHQ-9 indicating severe depressive symptoms,
- a score of ≥15 on the GAD-7, indicating severe symptoms of anxiety,
- experiencing active psychosis as judged by research staff via scores on the BSI.
Data sourced from ClinicalTrials.gov (NCT03974061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.