Treatment
Conditions
Keywords
Brief Acceptance and Commitment Therapy, HIV, Alcohol, Randomized Controlled Trial
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.
Interventions
BEHAVIORALBrief Acceptance and Commitment Therapy
Acceptance and Commitment Therapy utilizes mindfulness skills and values-guided behavioral action plans to decrease experiential avoidance and impact a broad array of psychological symptoms.
BEHAVIORALBrief Alcohol Intervention
The Brief Alcohol Intervention is a standard intervention that will be adapted for men and women living with HIV. The intervention will be matched in frequency and length to the brief ACT intervention.
Sponsors
Syracuse University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to which intervention is hypothesized to be superior and produce the intended effects. Outcome assessors will be blinded to which intervention participants received.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinking Days: Baseline (at Baseline) | Baseline | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period. |
| Number of Drinking Days: Post-Treatment (at 7-weeks Post-baseline) | Post-treatment (at 7-weeks post-baseline) | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period. |
| Number of Drinking Days: 3-months (at 3-months Post-baseline) | 3-months post-baseline | Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period. |
| Number of Drinking Days: 6-months (at 6-months Post-baseline) | 6-months post-baseline | Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period. |
| Number of Drinks Per Drinking Day: Baseline (at Baseline) | Baseline | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per day over the last 42-day period. |
| Number of Drinks Per Drinking Day: Post-Treatment (at 7-weeks Post-baseline) | Post-Treatment (7-weeks post-baseline) | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per drinking day over the last 42-day period. |
| Number of Drinks Per Drinking Day: 3-months (at 3-months Post-baseline) | 3-months post-baseline | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per drinking day over the last 42-day period. |
| Number of Drinks Per Drinking Day: 6-months (at 6-months Post-baseline) | 6-months post-baseline | Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinks per day over the last 42-day period. |
| Alcohol Consumption Measured by Phosphatidylethanol (PEth): Baseline (at Baseline) | Baseline | Alcohol use was assessed using the biomarker phosphatidylethanol (PEth). PEth is an abnormal phospholipid formed only in the presence of alcohol with an estimated half-life of 4-12 days and can be measured from dried blood spots. We calculated the percent of PEth positive tests (.50ng/ml) received at each study visit (out of all samples that were successfully sent back to our lab and successfully processed by the lab processing facility). |
| Alcohol Consumption Measured by Phosphatidylethanol (PEth): 6-months (at 6-months Post-baseline) | 6-months post-baseline | Alcohol use was assessed using the biomarker phosphatidylethanol (PEth). PEth is an abnormal phospholipid formed only in the presence of alcohol with an estimated half-life of 4-12 days and can be measured from dried blood spots. We calculated the percent of PEth positive tests (.50ng/ml) received at each study visit (out of all samples that were successfully sent back to our lab and successfully processed by the lab processing facility). |
| ART Adherence Measured by Self-Report: Baseline (at Baseline) | Baseline (at baseline) | ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days. |
| ART Adherence Measured by Self-report: Post-treatment (at 7-weeks Post-baseline) | Post-treatment (at 7-weeks post-baseline) | ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days. |
| ART Adherence Measured by Self-report: 3-months (at 3-months Post-baseline) | 3-months post-baseline | ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days. |
| ART Adherence Measured by Self-report: 6-months (at 6-months Post-baseline) | 6-months post-baseline | ART adherence was measured by self-report by asking participants to use a Likert-type scale of of 1 (very poor) to 6 (excellent) to report their ability to take all of their ART medication in past past 30 days. |
| ART Adherence Measured by Hair: Baseline | At Baseline | Adherence was intended to be measured via ARV levels in hair. Hair concentrations of ARVs have been shown to be the strongest independent predictor of virological success in prospective cohorts of HIV-infected patients. |
| ART Adherence Measured by Hair: 6-months (6-months Post-baseline) | 6-months post baseline | Adherence was intended to be measured via ARV levels in hair. Hair concentrations of ARVs have been shown to be the strongest independent predictor of virological success in prospective cohorts of HIV-infected patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Experiential Avoidance: Baseline (at Baseline) | Baseline | Symptoms of experiential avoidance were measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ is a 15-item measures that assesses six domains of experiential avoidance using a Likert-type scale that ranges from 1 to 6. A total score was calculated to indicate general symptoms of experiential avoidance. Total scores can range from 15 to 90 with higher scores indicating higher levels of experiential avoidance (and lower levels of acceptance). |
| Symptoms of Experiential Avoidance: 6-months (at 6-months Post-baseline) | 6 months post-baseline | Symptoms of experiential avoidance were measured with the Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ is a 15-item measures that assesses six domains of experiential avoidance using a Likert-type scale that ranges from 1 to 6. A total score was calculated to indicate general symptoms of experiential avoidance. Total scores can range from 15 to 90 with higher scores indicating higher levels of experiential avoidance (and lower levels of acceptance). |
| Symptoms of Depression: Baseline (at Baseline) | Baseline | Symptoms of depression were measured using the total score obtained on Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item standardized measure of depression severity with scores ranging from 0 to 27, and higher scores indicating higher levels of depression symptoms severity. Scores \<5 are considered none-mild, in the 10-14 range are considered "moderate," in the 15-19 range are considered "moderately severe," and in the 20-27 range are considered "severe." |
| Symptoms of Depression: 6-months (at 6-months Post-baseline) | 6 months post-baseline | Symptoms of depression were measured using the total score obtained on Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item standardized measure of depression severity with scores ranging from 0 to 27, and higher scores indicating higher levels of depression symptoms severity. Scores \<5 are considered none-mild, in the 10-14 range are considered "moderate," in the 15-19 range are considered "moderately severe," and in the 20-27 range are considered "severe." |
| Symptoms of Anxiety: Baseline (at Baseline) | Baseline | Symptoms of anxiety were measured using the total score obtained via the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 is a 7-item standardized measure of anxiety severity with score ranging from 0 to 21. With regard to symptoms of anxiety, score in the 0-4 range are considered "minimal," 5-9 range are considered "mild," 10-14 range are considered "moderate," and 15+ are considered "severe." |
| Symptoms of Anxiety: 6-months (at 6-months Post-baseline) | 6-months post-baseline | Symptoms of anxiety were measured using the total score obtained via the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 is a 7-item standardized measure of anxiety severity with score ranging from 0 to 21. With regard to symptoms of anxiety, score in the 0-4 range are considered "minimal," 5-9 range are considered "mild," 10-14 range are considered "moderate," and 15+ are considered "severe." |
| Number of Days Other Substances Used: Baseline (at Baseline) | Baseline | Substance use other than alcohol was measured by retrospective self-report via the 6-week Time Line Follow Back (TLFB) interview method which yields the number of days non-prescription drugs were used over the past 42 days. |
| Number of Days Other Substances Used: 6-months (6-months Post-baseline) | 6-months post-baseline | Substance use other than alcohol was measured by retrospective self-report via the 6-week Time Line Follow Back (TLFB) interview method which yields the number of days non-prescription drugs were used over the past 42 days. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah E Woolf-King, PhD
Syracuse University
PRINCIPAL_INVESTIGATORStephen A Maisto, PhD
Syracuse University
Participant flow
Pre-assignment details
There were two phases to this study. Phase I was the development of a treatment, and Phase II was a pilot randomized clinical trial. Only the second phase involved participants who were individually randomization to a treatment condition and to a graduate student (who was not enrolled) interventionist within that tx condition. In Phase I, individual in-depth interviews and focus groups were conducted with HIV providers (n = 10) and HIV patients (n = 13) - who were NOT enrolled in the trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.65 years STANDARD_DEVIATION 9.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 49 participants |
| Sex/Gender, Customized Declined to Answer | 0 Participants |
| Sex/Gender, Customized Female | 1 Participants |
| Sex/Gender, Customized Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 0 / 24 | 0 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
None listed