Acceptance and Commitment Therapy for HIV+ Hazardous Drinkers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSyracuse University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy (ACT)
BehavioralACT 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
BehavioralThe 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Acceptance and Commitment Therapy (ACT)Experimental treatment 1 intervention
Group B: Brief Alcohol Intervention (BI)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-baseline2
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-baseline3
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-baselineSecondary outcomes
1
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-baseline2
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-baseline3
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-baseline4
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-baselineOther outcomes
1
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-baseline2
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-baseline3
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-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Syracuse University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
University of Rochester
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov