Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.
研究概览
简要总结
Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.
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)
盲法说明
In order to limit measurement and attrition biases, the patient will be kept unaware of the hypotheses concerning the details of the evaluated programs (MBRP or control) and the program expected to be superior
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
- •Having a moderate to severe alcohol use disorder according to DSM 5 criteria.
- •The last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. The patient must have had at least 1 HDD during the last drinking period
排除标准
- •Severe depression (Beck Depression Inventory> 30)
- •Schizophrenic disorder,
- •Current maniac or hypomaniac episode,
- •Patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician.
- •Insufficient French understanding to complete the questionnaires
- •Pregnant or breastfeeding woman
- •Absence of social security regimen
- •Other mindfulness-based structured therapies
- •Refusal to sign the written consent. • The patient is under safeguard of justice or state guardianship
结局指标
主要结局
Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.
时间窗: 6 months
Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
次要结局
- Change in 4-week total alcohol consumption since baseline(12 months)
- Change in frequency of craving since baseline(12 months)
- Coping mechanism at baseline(Baseline)
- Cognitive impairment(Baseline)
- Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 3 months between groups(3 months)
- Anxiety at baseline(Baseline)
- Difficulties regulating emotion at baseline(Baseline)
- Impulsivity at baseline(Baseline)
- Initial mindfulness(Baseline)
- Change in strength of craving since baseline(12 months)
- Change in depression since baseline(12 months)
- Emotion regulation at baseline(Baseline)
- Change in emotion regulation since baseline(12 months)
- Changes in coping mechanism(12 months)
- Number of meditation sessions per week over the last 4 weeks(Month 6)
- Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 12 months between groups(12 months)
- Change in anxiety since baseline(12 months)
- Depression at baseline(Baseline)
- Change in quality of life since baseline(12 months)
- Changes in difficulties regulating emotion since baseline(12 months)
- Changes in impulsivity since baseline(12 months)