Clinical trial NCT03974061: Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
Official title: Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment
Keywords: Brief Acceptance and Commitment Therapy
HIV
Alcohol
Randomized Controlled Trial
Lead sponsor: Syracuse University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 49
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 randomized (stratified by gender and interventionist) to a treatment condition (brief acceptance and commitment therapy or a brief alcohol intervention) and an interventionist.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Alcohol use is a major problem in HIV care. Sixty-six percent of people living with HIV (PLWH) report using alcohol in the previous year, 8-20% report drinking at hazardous or heavy levels, and 30% report current binge drinking (\>5 drinks in an occasion in the past 30 days). PLWH who are hazardous drinkers, compared to those who abstain, experience a significant increased risk for: taking ART medications off schedule, suboptimal adherence to ART, and engaging in sexual risk behavior. Hazardous alcohol consumption has been found to affect every stage of the HIV care continuum, from diagnosis, to linkage to care, to retention, and viral suppression, making it a critical factor in HIV treatment that, if unaddressed, may significantly contribute to onward transmission.

Behavioral interventions for HIV-infected drinkers have provided limited evidence of benefit. HIV-prevention interventions do not typically address alcohol use, and it is often overlooked in HIV care. While there have been several clinical trials of alcohol interventions for PLWH in the US, these trials have shown mixed results for reducing alcohol use and improving HIV-related outcomes. 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 that PLWH who are at-risk drinkers are also likely to have multiple overlapping problems. It is estimated that 38% of PLWH meet criteria for both a substance use and another psychiatric disorder and also have a myriad of behavioral health needs (e.g., treatment adherence, condom use), any one of which would benefit from intervention. In order to adequately address these issues, PLWH require innovative alcohol intervention strategies that can also have an impact on other behavioral and mental health needs, in a format that can be feasibly delivered in the context of HIV care.

Brief acceptance and commitment therapy (ACT) is a promising intervention for HIV-infected drinkers. ACT is a transdiagnostic treatment that targets experiential avoidance (repeated attempts to eliminate or avoid difficult thoughts/feelings) 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. ACT has shown efficacy for treatment of anxiety depression, and chronic pain, making it a promising approach for HIV-infected hazardous drinkers. A recently published meta-analysis also indicates that ACT is efficacious for smoking, opiate use, methamphetamine use, and polydrug abuse, showing a small to medium effect size compared to active treatment controls (e.g., Cognitive Behavioral Therapy (CBT), pharmacotherapy). ACT's unique focus on skills that increase the ability to experience and accept, rather than change and control, urges and cravings related to substance use is different from more traditional forms of addiction treatment such as CBT. Indeed, a pilot RCT of a brief, telephone-delivered ACT intervention for smoking cessation had quit rates more than double that of traditional CBT for smokers with comorbid depression. However, ACT has not been studied as an intervention for hazardous drinkers.

The overall objective of this study is to adapt an existing brief ACT intervention and pilot test its feasibility, acceptability, and preliminary efficacy for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will have a significant effect on biological and self-reported measures of alcohol use and ART adherence. Secondary analyses will also examine changes in acceptance-a known mechanism of change in ACT -symptoms of depression and anxiety, and drug use, which we expect to differ by treatment group. The specific aims are as follows:

Aim 1: Adapt an existing brief ACT intervention for HIV-infected at-risk drinkers (ACT). We will accomplish this aim by: Modifying an existing 5-session, telephone-delivered ACT intervention for smoking cessation using a theoretical framework that has been previously used to systematically adapt evidence-based HIV interventions. We will conduct iterative multidisciplinary team meetings, focus group discussions with HIV clinic patients (N = 15-20), and qualitative interviews with HIV clinic providers (N = 5-10) to inform the adaptation process, get feedback on intervention content, and develop a new treatment manual.

Aim 2: Conduct a pilot superiority trial of ACT compared to a brief alcohol intervention. We will accomplish this aim by: Randomly assigning N = 74 HIV-infected hazardous drinkers (50% women) to the intervention developed in Aim 1 (n = 30) or a brief alcohol intervention previously developed for PLWH that is nearly equivalent in number and length of sessions. We will assess feasibility, acceptability, and primary trial outcomes of alcohol use and ART adherence immediately post-treatment and again at 3 and 6-months post-randomization. Secondary outcomes of changes in acceptance, symptoms of depression, symptoms of anxiety, and drug use will be assessed at all time points.

The proposed research will provide essential pilot data for an R01 application to conduct a full-scale RCT to determine the efficacy of ACT compared with the current evidence-based treatment for PLWH. If successful, this intervention will have broad implications for implementation in HIV and other integrated care settings.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age,
2. HIV-positive,
3. currently prescribed ART medication,
4. score of ≥4 (men) or ≥3 (women) on the AUDIT-C.

Exclusion Criteria:

1. Experiencing acute illness or declining health status when it is determined by a treatment provider that research participation is contraindicated,
2. unable to understand spoken English,
3. does not own a cell phone,
4. a score of 12 on the AUDIT-C, indicating high risk for a severe alcohol use disorder,
5. a score of ≥20 on the PHQ-9 indicating severe depressive symptoms,
6. a score of ≥15 on the GAD-7, indicating severe symptoms of anxiety,
7. experiencing active psychosis as judged by research staff via scores on the BSI.

Primary outcomes:
measure: Change in alcohol consumption from baseline to 7-weeks post-treatment
timeFrame: Change in alcohol consumption will be measured via the TLFB from baseline to end of treatment at 7-weeks.
measure: Change in alcohol consumption from 7-weeks post-treatment to 3-months post-baseline
timeFrame: Change in alcohol consumption will be measured via the TLFB from 7-weeks post-treatment to 3-months post-baseline.
measure: Change in alcohol consumption from 3-months post-baseline to 6-months post-baseline
timeFrame: Change in alcohol consumption will be measured via the TLFB from 3-months post-baseline to 6-months post-baseline.
measure: Change in alcohol consumption from baseline to 6-months post-baseline
timeFrame: Change in alcohol consumption will be measured via PEth from baseline to 6-months post-baseline.
measure: Change in ART adherence from baseline to 7-weeks post-treatment
timeFrame: Change in ART adherence will be measured via VAS from baseline to end of treatment at 7-weeks.
measure: Change in ART adherence from 7-weeks post-treatment to 3-months post-baseline
timeFrame: Change in ART adherence will be measured via VAS from 7-weeks post-treatment to 3-months post-baseline.
measure: Change in ART adherence from 3-months post-baseline to 6-months post-baseline
timeFrame: Change in ART adherence will be measured via VAS from 3-months post-baseline to 6-months post-baseline.
measure: Change in ART adherence from baseline to 6-months post-baseline
timeFrame: Change in ART adherence will be measured via ARV levels in hair from baseline to 6-months post-baseline.
Secondary outcomes:
measure: Acceptance
timeFrame: Acceptance will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups.
measure: Symptoms of Depression
timeFrame: Symptoms of depression will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups.
measure: Symptoms of Anxiety
timeFrame: Symptoms of anxiety will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups.
measure: Substance Use
timeFrame: Substance use will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups
Other outcomes:
measure: Chronic Pain
timeFrame: Pain will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups.
measure: HIV Medication Adherence Self-Efficacy
timeFrame: HIV Medication Adherence Self-Efficacy will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups.
measure: Alcohol-Related Problems
timeFrame: Alcohol-related problems will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups.
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
affiliation: Syracuse University
name: Sarah E Woolf-King, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Syracuse University
name: Stephen A Maisto, PhD
role: PRINCIPAL_INVESTIGATOR
References: