Mindfulness-Based Relapse Prevention as Video Conferencing Continuing Care to Promote Long Term Recovery From Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Recovery from AUD
研究概览
简要总结
This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.
详细描述
The goal of this study is to examine the effectiveness of mindfulness-based relapse prevention (MBRP) groups delivered via Zoom in promoting whole-person recovery from alcohol use disorder, and to examine how MBRP affects mechanisms of behavior change based on neurobiologically-informed addiction cycle domains. The investigators will use a hybrid effectiveness-implementation design to prospectively test the effectiveness of MBRP, as well as identify barriers and facilitators of MBRP group participation to inform future implementation of MBRP continuing care. Individuals (n=430) who have recently engaged in a change attempt to stop or reduce their drinking (via treatment or self-change) will be randomized to either MBRP groups via Zoom or referral to online mutual support. Participants will complete measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. Using a mixed methods design in the MBRP group, the investigators will examine facilitators and barriers to participation and engagement in MBRP, and assess the reach, effectiveness, adoption, implementation, and maintenance of MBRP via Zoom as continuing care in communities nationwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Received AUD treatment or made a self-change attempt to reduce or stop drinking in the past 3 months or is interested in reducing or stopping drinking
- •Meet criteria for a current AUD
- •Engaged in heavy drinking (more than 14 standard drinks per week or more than 4 drinks on a single day for men and more than 7 drinks per week or more than 3 drinks on a single day for women) in the past 6-months
- •Able to understand all study procedures and able to consent in English or Spanish.
- •Be willing to use a personal smart phone or tablet that is connected to the internet, or being willing to use a study-provided tablet
- •Have access to a valid U.S. mailing address for receiving dried blood spot card or blood collection device.
排除标准
- •Current symptoms of psychosis or mania.
- •Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
研究组 & 干预措施
Mindfulness-based relapse prevention
The MBRP condition will be based on an existing rolling group treatment manual, which consists of eight 60-minute sessions. Each session will begin with a brief mindfulness practice and a discussion of "what is mindfulness?" and the role mindfulness may play in recovery. The themes are repeated every eight sessions, but in every session the participant is bringing a new direct moment experience to the practices in that session. The groups will also consist of people in various stages of recovery and familiarity with the material, which can make for richer discussions of the material led by the group members themselves. Participants who are randomized to receive rolling MBRP treatment will also have access to the Thrive Recovery smart phone app, which includes audio-guided MBRP meditations for participants to practice in daily life.
干预措施: Mindfulness-based relapse prevention (Behavioral)
Referral to online mutual support groups
The referral group will consist of a brief 1:1 meeting with a research team member who will provide an orientation to online mutual support and discuss the SMART Recovery, Alcoholics Anonymous (AA), and other virtual meeting options and to discuss how to access mutual support via these platforms. Individuals will also have an opportunity to review the process of attending online groups, and will discuss technology issues that might arise during groups. The session will be 20-30 minutes in length.
干预措施: Online Mutual Support Groups (Behavioral)
结局指标
主要结局
Recovery from AUD
时间窗: Change from baseline to three year follow-up period
Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking over the past 28 days with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the World Health Organization Quality of Life domain scores (each of 26 items scored from 1 to 5 on a response scale, which are then transformed linearly to a 0-100-scale) and the 36-item Short Form Health Survey Mental Health Component Score (scored on a 0-100 scale). Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved.
Recovery from AUD
时间窗: Change from baseline to three year follow-up period
Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking over the past 28 days with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the World Health Organization Quality of Life domain scores (each of 26 items scored from 1 to 5 on a response scale, which are then transformed linearly to a 0-100-scale) and the 36-item Short Form Health Survey Mental Health Component Score (scored on a 0-100 scale). Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved.
次要结局
- Addiction Cycle - Executive Function Scale(Change from baseline to three year follow-up period)
- Purpose in Life test(Change from baseline to three year follow-up period)
- Reduction in World Health Organization risk drinking levels(Change from baseline to three year follow-up period)
- PROMIS Alcohol Negative Consequences(Change from baseline to three year follow-up period)
- PROMIS Preference Score (PROPr)(Change from baseline to three year follow-up period)
- Penn Alcohol Craving Scale(Change from baseline to three year follow-up period)
- Alcohol Use Disorder symptoms(Change from baseline to three year follow-up period)
- Reduction in percent heavy drinking days(Change from baseline to three year follow-up period)
- Reduction in drinks per drinking day(Change from baseline to three year follow-up period)
- Reduction in percent drinking days(Change from baseline to three year follow-up period)
- World Health Organization Quality of Life (WHOQOL - BREF) Measure(Change from baseline to three year follow-up period)
- Substance Use Moderation Self-Efficacy Scale (SUM-SES)(Change from baseline to three year follow-up period)
- Addiction Cycle - Negative Emotionality Scale(Change from baseline to three year follow-up period)
- Addiction Cycle - Incentive Salience Scale(Change from baseline to three year follow-up period)
- Reduction in World Health Organization risk drinking levels(Change from baseline to three year follow-up period)
- PROMIS Alcohol Negative Consequences(Change from baseline to three year follow-up period)
- PROMIS Preference Score (PROPr)(Change from baseline to three year follow-up period)
- Alcohol Use Disorder symptoms(Change from baseline to three year follow-up period)
- Penn Alcohol Craving Scale(Change from baseline to three year follow-up period)
- Reduction in percent heavy drinking days(Change from baseline to three year follow-up period)
- Reduction in drinks per drinking day(Change from baseline to three year follow-up period)
- Reduction in percent drinking days(Change from baseline to three year follow-up period)
- World Health Organization Quality of Life (WHOQOL - BREF) Measure(Change from baseline to three year follow-up period)
- Substance Use Moderation Self-Efficacy Scale (SUM-SES)(Change from baseline to three year follow-up period)
- Addiction Cycle - Negative Emotionality Scale(Change from baseline to three year follow-up period)
- Addiction Cycle - Incentive Salience Scale(Change from baseline to three year follow-up period)
- Addiction Cycle - Executive Function Scale(Change from baseline to three year follow-up period)
- Purpose in Life test(Change from baseline to three year follow-up period)
- PROMIS Meaning and Purpose measure(Change from baseline to three year follow-up period)