From Feasibility to Efficacy: the Use of EMDR to Reduce Craving and Drinking Behaviour in Alcohol Dependent Outpatients - A Multiple Baseline Study and Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Changes in number of heavy drinking days in the previous 30 days
研究概览
简要总结
One interesting approach to the treatment of addiction is the use of Eye Movement Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the results are promising and suggest that further research on this subject is warranted.
This proposal consists of two studies to test and determine the acceptability, feasibility and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further understanding in underlying working mechanisms.
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
- •A primary diagnosis of alcohol dependence or abuse (meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR criteria (American Psychiatric Association, 2000);
- •Age of at least 18 years or older;
- •Can speak and read Dutch language;
- •Consent (written) to postponed information given.
排除标准
- •Meeting the DSM-IV-TR (American Psychiatric Association, 2000) criteria for current (in the past 2 weeks) addiction and regular use (at least once per week in the last two weeks before baseline screening) of drugs other than alcohol or nicotine (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
- •Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current (in the last two weeks before baseline screening) regular alcohol use (at least > 21E (women) or > 28E (men) per week) (relative exclusion: decision on case-by-case basis) (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
- •Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current post-traumatic stress disorder (PTSD);
- •Severe, current (since the start of regular treatment) psychiatric symptoms (especially manic, psychotic, suicidal and aggressive symptoms) that may endanger participants or others and jeopardize study adherence.
研究组 & 干预措施
Community Reinforcement Approach
Treatment as usual, provided in out-patient setting
干预措施: Community Reinforcement Approach (Behavioral)
Community Reinforcement Approach + EMDR
Treatment as usual + additional sessions of EMDR
干预措施: EMDR (Behavioral)
Community Reinforcement Approach + EMDR
Treatment as usual + additional sessions of EMDR
干预措施: Community Reinforcement Approach (Behavioral)
结局指标
主要结局
Changes in number of heavy drinking days in the previous 30 days
时间窗: Changes in baseline number of heavy drinking days in the previous 30 days, at post-intervention, and 1 and 6 month follow-up
Changes in patient-reported number of heavy drinking days (defined as days on which 5 or more standard drinks of alcohol were consumed during the previous 30 days, as assessed with the alcohol TimeLine FollowBack (TLFB) method).
次要结局
- Changes in alcohol implicit associations(Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up)
- Time to first alcohol consumption(Up to 6 months post-intervention)
- Changes in patient-reported desire thinking(Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up)
- Changes in alcohol attentional bias(Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up)
- Changes in patient-reported coping self-efficacy(Changes in baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up)
- Changes in severity of patient-reported problematic alcohol use(Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up)
- Changes in biomarker levels(Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months)
- Changes in patient-reported craving(Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up)
- Changes in patient-reported quality of life(Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up)
- Changes in patient-reported rumination(Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up)
- Drop out(Up to 6 months post-intervention)
- Changes in number of total drinks consumed in the previous 30 days(Changes in baseline number of total drinks consumed in the previous 30 days, at post-intervention, and 1 and 6 month follow-up)
- Changes in average drinks per occasion in the previous 30 days(Changes in baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up)
- Changes in patient-reported positive and negative affect(Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up)
研究者
W. Markus
MSc
IrisZorg