Randomized Trial of Intensive MI to Improve Drinking Outcomes Among Women

描述(由申请人提供)：我们正在进行的对甲基苯丙胺(MA)依赖的强化动机访谈(IMI)研究中有一个意想不到但重要的发现：有酒精问题的女性(N=87)如果被分配到IMI条件下而不是标准的MI(SMI)比较条件下，她们减少饮酒的程度要显著得多。在4个月和6个月的随访中，IMI条件下的女性酒精问题的减少幅度更大。有趣的是，轨迹显示饮酒问题在治疗期间和治疗后持续下降，研究条件之间的差异在4个月(P&lt；0.05)和6个月(P&lt；0.01)的随访中变得更大。6个月的治疗效果为中到大型，Cohen‘s d=0.63。对于男性来说，饮酒没有因研究条件而异。当前样本在研究干预对饮酒的影响方面的一个重要限制是当前的研究 目标是依赖MA的人。因此，酒精问题是次要的，通常参与者进入时酒精问题的严重性相对较低，改进的空间有限。这项应用的主要目标将是测试IMI对目前有酒精依赖的女性的疗效。招募更多有更严重饮酒问题的女性样本，将能够证明研究条件之间的更大差异。为了评估持续改善的趋势是否持续超过6个月，我们将采访12个月大的女性。样本将由220名妇女随机分配到IMI(9次)和/或SMI(1次加8次营养教育，以实现研究条件的时间相等)。在两种研究条件下的所有参与者都将获得3个认知行为 每周都有心理咨询小组。该研究回应了NIAAA发布的PA-10-100《酒精使用障碍：治疗、服务研究和康复》(R01)。我们的提案通过提出一项第二阶段随机临床试验来解决这一公告的优先事项，该试验将对酒精依赖女性的IMI和SMI进行比较。这项研究也是为了响应巴勒斯坦权力机构对评估变化机制的研究的呼吁。与许多以前的MI研究不同，我们将采用有限的排除标准，并将招募一些同时存在药物和精神障碍的参与者。因此，这项研究响应了PA对共病研究的呼吁。程序将借鉴我们目前成功的随机对照试验评估MA依赖的IMI。当前研究的成功方面包括招聘目标的实现，对手册和研究方案的出色遵守，以及出色的随访率(&gt；90%)。这项拟议的研究将在与目前的研究相同的门诊治疗计划中进行，即加利福尼亚州拉斐特的新叶治疗中心。主要结果将是在基线以及2、6和12个月评估的饮酒和酒精问题的测量。次要结果将包括成瘾严重指数、精神问题和创伤症状。定量和定性程序将调查潜在的中介因素，包括留存、治疗联盟、自我效能、动机、满意度和外部服务。

DESCRIPTION (provided by applicant): An unexpected yet important finding from our ongoing study of Intensive Motivational Interviewing (IMI) for methamphetamine (MA) dependence is women with alcohol problems (N=87) are reducing their drinking significantly more if they are assigned to the IMI condition as opposed to a standard MI (SMI) comparison condition. Reduction of alcohol problems has been larger for women in the IMI condition at 4- and 6-month follow-up. Interestingly, trajectories show continuing declines in drinking problems during and after treatment, and differences between study conditions grow larger between 4-month (p<.05) and 6-month (p<.01) follow-up. Treatment effects at 6 months are medium to large, Cohen's d=0.63. There are no drinking differences by study condition for men. An important limitation of the current sample in terms of studying the intervention's effects on drinking is the current study targets persons with MA dependence. Alcohol problems are therefore secondary and typically participants enter with relatively low severity of alcohol problems and limited room for improvement. The primary goal of this application will be to test the efficacy of IMI for women with current alcohol dependence. Recruiting a larger sample of women with more serious drinking problems will enable demonstration of larger differences between study conditions. To assess if the trend of continuing improvement continues beyond 6 months we will interview women at 12 months. The sample will consist of 220 women randomly assigned to IMI (9 sessions) and or SMI (1 session plus 8 nutrition education sessions to achieve time equivalence of study conditions). All participants in both study conditions will receive 3 cognitive behavioral counseling groups each week. The study responds to PA-10-100, "Alcohol Use Disorders: Treatment, Services Research, and Recovery" (R01) issued by NIAAA. Our proposal addresses the priorities of this announcement by proposing a phase II randomized clinical trial that will compare IMI to SMI for alcohol dependent women. The study is also designed to respond to the PA's call for studies assessing the mechanisms of change. Unlike many previous studies of MI, we will employ limited exclusion criteria and will enroll participants who present some co-existing drug and psychiatric disorders. Thus, the study responds to the PA's call for studies on comorbidities. Procedures will draw from our current successful RCT assessing IMI for MA dependence. Successful aspects of the current study include accomplishment of recruitment goals, excellent adherence to the manual and research protocol, and excellent follow-up rates (>90%). The proposed study will take place at the same outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette, California. Primary outcomes will be measures of drinking and alcohol problems assessed at baseline and 2, 6, and 12 months. Secondary outcomes will include the Addiction Severity Index, psychiatric problems and trauma symptoms. Quantitative and qualitative procedures will investigate potential mediators, including, retention, therapeutic alliance, self-efficacy, motivation, satisfaction, and outside services.