Mindfulness Meditation For Alcohol Relapse Prevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Time to Relapse (Resumption of Drinking)
研究概览
简要总结
The purpose of this 52-week clinical trial is to see if the meditation-based intervention, adjunctive to standard of care therapy, can reduce relapse and improve psychological health among adults recovering from alcohol dependence.
详细描述
The goal of this partially-blinded, two-arm clinical trial was to test whether the Mindfulness Meditation Relapse Prevention (meditation), combined with 'standard of care' (SOC) therapy, is more effective in preventing a return to drinking than SOC alone (wait-list control) among adult recovering alcoholics. The intervention was manualized and based on existing models. It was proposed that meditation may improve outcomes of interest through reduction of the severity of stress-related relapse risk factors such as perceived stress, anxiety, depression, craving and emotion dysregulation, and the level of stress-sensitive biomarkers (cytokine interleukin-6, liver enzymes).
For this study, 123 adult alcohol dependent subjects were recruited from collaborating treatment centers, randomly assigned to one of two equal study arms, and followed for 26-weeks (Period 1, Randomized Controlled Trial, RCT). The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject treatment satisfaction and adherence as secondary outcomes. It also gathered preliminary data on potential mechanisms of meditation action. After the completion of their 26-week RCT (Period 1), controls were eligible to receive the meditation intervention ("cross-over"), and all participants were followed-up for additional 26 weeks (non-randomized Period 2).
This study will provide evidence about the efficacy of meditation for alcohol relapse prevention, will further our understanding of relapse and the potential mechanisms of meditation action, direct future research and guide clinical decision-making.
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
- Single (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
- 否
入选标准
- •Alcohol dependence diagnosis
- •Completed at least 2 weeks of IOP or (IOP equivalent=at least 2 days per week) for alcohol dependence
- •Sober since beginning of outpatient treatment
- •English fluency; ability to fill out surveys
- •Permanent home address and telephone
- •At least 18 years old
- •Score >13 on the Perceived Stress Scale
排除标准
- •Alcohol abstinence >14 weeks before enrollment
- •Current, regular meditation
- •Pre-existing bipolar, schizophrenia, or delusional disorder
- •Regular drug use (other than tobacco) in last 2 weeks
- •Inability to reliably participate
结局指标
主要结局
Time to Relapse (Resumption of Drinking)
时间窗: 26 weeks
Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.
Percent Heavy Drinking Days
时间窗: 26 weeks
Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.
Percent Days Abstinent From Alcohol
时间窗: 26 weeks
Measures percent days abstinent from alcohol
次要结局
- Subject Treatment Adherence(8 weeks)
- Subject Treatment Satisfaction(8 weeks)
- Drinker Inventory of Consequences(26 weeks)
