Acceptance and Commitment Therapy for Alcohol Consumption in People with HIV
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Syracuse University
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Is Acceptance and Commitment Therapy (ACT) safe for people with HIV and alcohol use issues?
ACT is generally considered safe for people with HIV and alcohol use issues, as studies have shown it to be acceptable and well-received by participants. It focuses on improving mental health and coping strategies without significant safety concerns reported.
24567How is Acceptance and Commitment Therapy (ACT) different from other treatments for alcohol consumption in people with HIV?
Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping individuals accept their thoughts and feelings rather than trying to change them, and it encourages commitment to personal values to guide behavior. This approach is particularly beneficial for people with HIV who face multiple mental health and substance-related challenges, as it addresses core processes common to these issues.
13467What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for alcohol consumption in people with HIV?
ACT has been shown to help reduce alcohol use and improve mental health in people with alcohol use disorder and other mental health conditions. In studies, ACT has been effective in reducing drinking and cravings, and improving depression and anxiety symptoms, which suggests it could be beneficial for people with HIV who struggle with alcohol use.
34567Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on alcohol use and mental health, so it's best to discuss your medications with the trial team.
Eligibility Criteria
This trial is for adult individuals living with HIV who drink alcohol at unhealthy levels. Participants must be willing to undergo therapy sessions over the phone and provide self-reports on their drinking habits, as well as other psychological and functional outcomes.Inclusion Criteria
I am 18 or older and receiving HIV treatment.
Participant Groups
The study tests if Acceptance and Commitment Therapy (ACT) can reduce alcohol use and improve mental health among people with HIV compared to a Brief Alcohol Intervention (BI). It's a randomized trial where participants are assigned by chance to one of these two treatments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Acceptance and Commitment Therapy (ACT)Experimental Treatment1 Intervention
Participants randomized to the ACT arm will receive six, weekly, 30-45-minute ACT intervention sessions delivered via telephone.
Group II: Brief Alcohol Intervention (BI)Active Control1 Intervention
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Syracuse UniversitySyracuse, NY
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Who is running the clinical trial?
Syracuse UniversityLead Sponsor
University of California, San FranciscoCollaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
University of RochesterCollaborator
References
Harmful alcohol consumption and patterns of substance use in HIV-infected patients receiving antiretrovirals (ANRS-EN12-VESPA Study): relevance for clinical management and intervention. [2015]Alcohol abuse affects secondary prevention and disease progression in HIV-infected patients, and adherence and response to treatment in those chronically treated. The objective of this study was to estimate the prevalence of harmful alcohol consumption (HAC) using various indicators and identify which groups of patients may require specific targeted interventions for HAC risk reduction. A cross-sectional survey, based on a random sample representative of people living with HIV/AIDS (PLWHA) was carried out in 102 French hospital departments delivering HIV care. As alcohol abuse is particularly detrimental to patients receiving highly active antiretroviral therapy (HAART), we focused only on those individuals receiving HAART with complete alcohol assessment (CAGE, AUDIT-C, regular binge drinking, N=2340). Collected information included medical and socio-demographic data, HIV risk behaviors, adherence to treatment and substance and alcohol use, together with depression, anxiety, and experience of attempted suicide or sex work. HAC prevalence was evaluated as follows: 12% (CAGE score > or =2), 27% (AUDIT-C), and 9% (regular binge drinking). Three groups were at higher risk of HAC: men who have sex with men using stimulants, polydrug users, and to a lesser degree, ex-drug users. Innovative intervention strategies to reduce HAC and improve HIV prevention and HAART adherence in various PLWHA populations need urgent testing and implementation. Such interventions for alcohol risk reduction remain central to promoting improved HIV prevention and assuring HAART effectiveness in these populations.
[Acceptance and commitment therapy]. [2019]Acceptance and commitment therapy (ACT) is a third generation of cognitive-behavioral therapies. The point is to help patients to improve their psychological flexibility in order to accept unavoidable private events. Thus, they have the opportunity to invest energy in committed actions rather than struggle against their psychological events.
Acceptance and Commitment Therapy in the Treatment of Alcohol Use Disorder and Comorbid Affective Disorder: A Pilot Matched Control Trial. [2018]This study examined whether acceptance and commitment therapy (ACT) enhances treatment as usual (TAU) in improving treatment outcomes in patients with alcohol use disorder (AUD) and comorbid affective disorder. Fifty-two participants were included in the study, of whom 26 were patients with AUD and either depression or bipolar disorder treated with ACT group therapy in parallel with TAU (inpatient integrated treatment) and 26 were matched controls who had received TAU alone. Drinking and craving outcomes were total alcohol abstinence, cumulative abstinence duration (CAD) and Obsessive Compulsive Drinking Scale (OCDS) scores at 3 and 6 months postintervention. Affective and anxiety outcomes were Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and Young Mania Rating Scale (YMRS) scores at these follow-ups. Baseline demographic and clinical characteristics were similar in both groups. Retention rates were high: 100% of the ACT group were followed up at 3 and 6 months; 92.3% and 84.6% of the TAU alone group were followed up at 3 and 6 months, respectively. Patients in the ACT group reported significantly higher CAD at 3 and 6 months, significantly lower BDI and BAI scores at 3 and 6 months, and significantly lower OCDS scores at 3 months, than those who received only TAU. No other significant differences in treatment outcomes were found between the groups. ACT provides added benefit to TAU in improving drinking, craving, depression and anxiety outcomes in patients with AUD and comorbid affective disorder. Most treatment improvements were sustained over a 6-month follow-up period.
Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. [2023]Alcohol use is a significant problem in HIV care, and clinical trials of alcohol interventions for people living with HIV infection (PLWH) have produced mixed results. The purpose of this qualitative study was to collect preliminary data on the practical feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a treatment for PLWH who are hazardous drinkers. A total of 25 PLWH participated in individual interviews. Four major themes emerged from the thematic analysis: (I) Perceived Appropriateness for PLWH and People who use Alcohol and/or other Substances, (II) General Satisfaction and Dissatisfaction, (III) Positive and Negative Effects on Participants and (IV) Facilitators and Barriers to Implementing ACT Intervention Strategies.
The Use of Acceptance and Commitment Therapy in Substance Use Disorders: A Review of Literature. [2022]Acceptance and commitment therapy (ACT) is a form of behavioral therapy that teaches people to learn to accept rather than avoid challenging situations in their lives. ACT has shown to be an intervention with great success in the reduction of various mental disorders and substance use disorders (SUDs). The core of ACT when used in SUD treatment is guiding people to accept the urges and symptoms associated with substance misuse (acceptance) and use psychological flexibility and value-based interventions to reduce those urges and the symptoms (commitment). The purpose of this study is to review the existing literature to examine the evidence on the use of ACT in the management of SUD.
Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. [2022]Alcohol use among people living with HIV (PWH) has been increasingly recognized as an important component of HIV care. Transdiagnostic treatments, such as Acceptance and Commitment Therapy (ACT), that target core processes common to multiple mental health and substance-related problems, may be ideal in HIV treatment settings where psychological and behavioral health comorbidities are high. In advance of a randomized clinical trial (RCT), the overall objective of this study was to systematically adapt an ACT-based intervention originally developed for smoking cessation, into an ACT intervention for PWH who drink at hazardous levels. Consistent with the ADAPT-ITT model, the adaptation progressed systematically in several phases, which included structured team meetings, three focus group discussions with PWH (N = 13), and in-depth interviews with HIV providers (N = 10), and development of standardized operating procedures for interventionist training, supervision, and eventual RCT implementation. The procedures described here offer a template for transparent reporting on early phase behavioral RCTs.
Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. [2023]Roughly 40% of persons with HIV (PWH) are not consistently involved in HIV care in the US. Finding out-of-care PWH is difficult, but hospitalization is common and presents an opportunity to re-engage PWH in outpatient care. The aims of this study were to (1) develop an Acceptance and Commitment Therapy (ACT)-based intervention for hospitalized, out-of-care PWH who endorse avoidance-coping to improve HIV treatment engagement; (2) examine the intervention’s initial feasibility and acceptability; and (3) to revise the study protocol (including the intervention), based on stakeholder feedback, in preparation for a randomized controlled trial (RCT) comparing ACT to treatment as usual. Therapists and HIV care experts developed a four-session ACT-based intervention to be delivered during hospitalization. Fifteen hospitalized patients with poorly controlled HIV enrolled in the open trial, eight completed four sessions, two completed three sessions, and seven provided qualitative feedback. Patients universally liked the intervention and the holistic approach to mental health and HIV care. Refinements included repeating key concepts, including representative graphics, and translating to Spanish. Among the patients who attended ≥3 ACT sessions, 5/10 attended a HIV-care follow-up visit and 5/7 who had labs had a viral load