Randomized Trial of Intensive MI to Improve Drinking Outcomes Among Women

描述（由申请人提供）：我们正在进行的甲基苯丙胺（MA）依赖性强化动机访谈（IMI）研究中的一个意想不到但重要的发现是，如果将有酒精问题的女性（N=87）分配到IMI条件下，而不是标准MI（SMI）比较条件下，则她们的饮酒量显着减少。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，轨迹显示治疗期间和治疗后饮酒问题持续下降，并且研究条件之间的差异在4个月（p<.05）和6个月（p<.01）随访期间变得更大。6个月时的治疗效果为中等至大，Cohen d=0.63。男性在不同研究条件下的饮酒量没有差异。在研究干预措施对饮酒的影响方面，当前样本的一个重要局限性是当前的研究 目标人群为MA依赖者。因此，酒精问题是次要的，通常参与者进入酒精问题的严重程度相对较低，改善的空间有限。该应用程序的主要目标是测试IMI对当前酒精依赖的女性的疗效。招募更大样本的妇女更严重的饮酒问题将能够证明更大的差异之间的研究条件。为了评估持续改善的趋势是否持续超过6个月，我们将在12个月时采访女性。样本将包括220名随机分配到IMI（9个疗程）和/或SMI（1个疗程加8个营养教育疗程，以实现研究条件的时间等效性）的女性。两种研究条件下的所有参与者都将接受3次认知行为测试。 每周咨询一次。该研究响应了NIAAA发布的PA-10-100“酒精使用障碍：治疗，服务研究和恢复”（R 01）。我们的提案通过提出一项II期随机临床试验来解决这一公告的优先事项，该试验将比较酒精依赖女性的IMI和SMI。这项研究也是为了响应巴勒斯坦权力机构关于研究评估变化机制的呼吁。与许多以前的MI研究不同，我们将采用有限的排除标准，并将招募存在某些共存药物和精神疾病的参与者。因此，该研究响应了PA关于合并症研究的呼吁。程序将借鉴我们目前成功的RCT评估MA依赖的IMI。目前研究的成功方面包括完成招募目标，严格遵守手册和研究方案，以及出色的随访率（>90%）。拟议的研究将在与当前研究相同的门诊治疗项目中进行，即位于加州拉斐特的新叶治疗中心。主要结果将是在基线和2，6和12个月评估的饮酒和酒精问题的措施。次要结果将包括成瘾严重程度指数、精神问题和创伤症状。定量和定性程序将调查潜在的调解人，包括，保留，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.