An interventional study of Acceptance and Commitment Therapy (ACT) and Brief Alcohol Intervention in HIV-1-infection and Alcohol Drinking, sponsored by Syracuse University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Syracuse University · Not applicable, Interventional, and Treatment
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.
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).
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 300 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Syracuse University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Referrals for mental health treatment will be given to all participants who screen out.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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
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
Alcohol use - Frequency
The Timeline Followback will be used to estimate the Number of Drinking Days 30 days prior to study visit appointment
Time frame: 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
Time frame: 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.
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Symptoms of Anxiety
Symptom of anxiety will be measured using the Generalized Anxiety Questionnaire (GAD-7). There are 7 items rated on a scale of 0 (not at all) to 3 (nearly every day). The GAD-7 total score ranges from 0 (no anxiety) to 21 (severe anxiety).
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Symptoms of Depression
Symptoms of depression will be measured using the Patient Health Questionnaire (PHQ-9). There are 9 items rated on a scale of 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0 (no depression) to 27 (severe depression).
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Self-reported levels of Stress
Self-reported levels of stress will be measured using the Perceived Stress Scale (PSS). The PSS consists of 10 items rated on a scale from 0 (never) to 4 (very often). The total score ranges from 0 (indicating no stress) to 40 (indicating high levels of stress).
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Biological levels of Stress
Biological levels of stress will be measured by assessing levels of cortisol in samples of nails
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Symptoms of Experiential Avoidance
Experiential Avoidance will be measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ consists of 15 items rated on a scale from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 15 (indicating low experiential avoidance) to 90 (indicating high experiential avoidance).
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Alcohol-related Problems
Alcohol-related problems will be measured using the Short Inventory of Problems (SIP). The SIP consists of 15 items rated either 0 (no) or 1 (yes). Higher total scores indicate more alcohol-related problems.
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Adherence to HIV Medications
Adherence to HIV medications will be measured using the Visual Analogue Scale (VAS). The VAS is a single-item measure where individuals rate their adherence on a scale from 0% (no adherence) to 100% (perfect adherence). The score is represented as a percentage, with higher scores indicating better adherence to HIV medication.
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Functional Impairment
Functional impairment will be assessed using the Brief Inventory of Psychosocial Functioning (B-IPF). The B-IPF consists of 7 items rated on a scale from 1 (not at all) to 6 (very much). The total score ranges from 0 (indicating no functional impairment) to 42 (indicating severe functional impairment).
Time frame: Measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline
Plan to share: Yes — Per NOT-AA-22-011, this study will submit and share data with NIAAA Data Archive (NIAAADA), a data repository housed within the National Institute of Mental Health (NIMH) Data Archive (NDA). To this end, the study will fulfill all tasks and expectations associated with NIAAA Data Archive (NIAAADA) Data Sharing Plan (DSP)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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