Clinical trial NCT06648629: Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
Official title: Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV-1-infection
Alcohol Drinking
Keywords: HIV
Alcohol
ACT
Treatment
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Rochester
name: University of California, San Francisco
First posted: 2024-10-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the following two pre-specified treatment groups: Acceptance and Commitment Therapy or Brief Alcohol Intervention.
Primary purpose: TREATMENT

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.

Detailed description: Alcohol use has a substantial impact on HIV care. Sixty-seven percent of people with HIV (PWH) report using alcohol in the previous year, 27-40% report drinking at unhealthy levels and \~30% meet criteria for alcohol use disorder (AUD). PWH who are unhealthy drinkers, compared to those who abstain or drink relatively less, experience a significant increase in risk for: mortality, lack of viral suppression, less antiretroviral therapy (ART) utilization and sub-optimal adherence to ART. Unhealthy alcohol consumption has been found to affect nearly every stage of the HIV care continuum, making it a critical factor in HIV treatment.

Randomized clinical trials (RCTs) of alcohol interventions for PWH have had limited success, likely due to lack of attention to co-morbid mental health problems. There have been several reviews of this literature, the most recent of which identified 9 non-overlapping behavioral trials developed specifically to target alcohol use and conducted in the U.S. with adult samples of PWH. Only four of these nine trials resulted in significant effects on alcohol-related outcomes and only two trials had effects on alcohol-related outcomes that were significantly different from the control group at 12-month follow-up. One hypothesized reason for this limited success is an increasingly recognized comorbidity of co-occurring unhealthy alcohol use and other mental health-related problems among PWH. Indeed, up to 63% of PWH meet criteria for both a substance use disorder and another psychiatric disorder-necessitating a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health and substance-related problems\[. One trans-diagnostic mechanism that is particularly 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) is a promising trans-diagnostic intervention for PWH.

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. A recent review of 20 meta-analyses, based on 133 studies, found ACT to be efficacious across multiple psychological and behavioral health-related outcomes including: depression, anxiety, chronic pain, stress, and trans-diagnostic combinations of conditions. Additionally, three meta- analyses have found ACT to be efficacious for smoking and other drug use and there is an emerging literature suggesting ACT is a promising approach for alcohol use. There have not, however, been any full- scale RCTs of ACT for alcohol use among any population, including PWH. Given ACT's potential to improve multiple psychological and alcohol-related problems simultaneously, it holds great promise as an intervention for PWH who are unhealthy drinkers. 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). With a multidisciplinary team, and with two rounds of input from PWH, the investigators developed a six- session, telephone-delivered ACT intervention for alcohol use and subsequently conducted a pilot feasibility/acceptability RCT. The investigators found high acceptability of the adapted ACT intervention, and evidence of feasibility for conducting a full-scale, remote, RCT.

The overall objective of this application is therefore to determine the relative efficacy of ACT, compared to a standard Brief Alcohol Intervention (BI), for reducing alcohol use and comorbid symptoms of depression, anxiety, and stress among adult PWH who are unhealthy drinkers. The application's specific aims are to:

Aim 1: Determine the relative efficacy of ACT, compared to BI, for reducing alcohol use among PWH.

To achieve this aim, the investigators will: conduct a fully remote, relative efficacy RCT. The investigators will randomly assign 300 PWH who are unhealthy drinkers 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 an objective biomarker (phosphatidylethanol) - at baseline, post-treatment (7 weeks post-baseline), and again 3-, 6-, and 12-months post-randomization. The investigators hypothesize that: the two treatments will have significant, and statistically equivalent, effects on alcohol use at post-treatment and 3-months (H1) and, consistent with a sleeper effect for ACT, the ACT condition will have superior alcohol outcomes at 6- and 12-months post- randomization (H2).

Aim 2: Determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes. To achieve this aim, the investigators will: measure EA and determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes. The investigators hypothesize that: ACT will have superior outcomes on stress, anxiety, depression, and functional outcomes at all follow-up timepoints (H3) and that EA will be a significant mediator of all treatment effects, including alcohol use (H4).

Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol use - Frequency
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Alcohol Use - Quantity
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Phosphatidylethanol (PEth)
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Secondary outcomes:
measure: Symptoms of Anxiety
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Symptoms of Depression
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Self-reported levels of Stress
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Biological levels of Stress
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Symptoms of Experiential Avoidance
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Other outcomes:
measure: Alcohol-related Problems
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Adherence to HIV Medications
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
measure: Functional Impairment
timeFrame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References: