Randomized Trial of Intensive MI to Improve Drinking Outcomes Among Women

强化心肌梗死改善女性饮酒结果的随机试验

• 批准号: 9088227
• 负责人: DOUGLAS L POLCIN
• 金额: $ 69.15万
• 依托单位: PUBLIC HEALTH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-05 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9088227
• 关键词: Accidents; Achievement; Address; Adherence; Aftercare; Age; Alcohol abuse; Alcohol dependence; Alcoholics Anonymous; Alcohols; Area; Attention; Behavioral; California; Centers for Disease Control and Prevention (U.S.); Client; Cognitive; Comorbidity; Data; Development; Dose; Enrollment; Evolution; Exclusion Criteria; Family; Friends; Goals; Health; Health Services Research; Healthcare; Heavy Drinking; Illicit Drugs; Individual; Intervention; Interview; Law Enforcement; Manuals; Measures; Mediating; Mediator of activation protein; Medical; Mental disorders; Methamphetamine; Methamphetamine dependence; Modeling; Motivation; NIH Program Announcements; National Institute on Alcohol Abuse and Alcoholism; Outcome; Outpatients; Participant; Perception; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Plant Leaves; Population; Procedures; Productivity; Protocols documentation; Qualitative Methods; Randomized; Randomized Clinical Trials; Recovery; Recruitment Activity; Research; Research Support; Risk; Sampling; Self Efficacy; Services; Severities; Social support; Staging; Subgroup; Testing; Therapeutic; Time; Treatment outcome; Woman; Work; Workplace; addiction; alcohol abuse therapy; alcohol use disorder; cost; design; drinking; effective therapy; efficacy testing; follow-up; group counseling; improved; indexing; innovation; intervention effect; male; men; methamphetamine use; motivational enhancement therapy; nutrition education; primary outcome; programs; psychiatric symptom; randomized trial; satisfaction; secondary outcome; social; tool; trauma symptom; treatment center; treatment effect; treatment group; treatment program; trend; trial comparing; vehicular accident

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.

描述（由申请人提供）：我们正在进行的对甲基苯丙胺的强度动机访谈（MA）依赖性研究中的一个意外但重要的发现是，如果与标准MI（SMI）比较条件相对，则患有酒精问题的女性（n = 87）的饮酒量大大减少了饮酒。在4个月和6个月的随访中，在IMI状况下，在IMI状况下，酒精问题的减少量更大。有趣的是，轨迹在治疗期间和之后表明饮酒问题的持续下降，研究条件之间的差异在4个月（p <.05）和6个月（p <.01）随访之间增长。 6个月时的治疗效果中等至大，Cohen的D = 0.63。男性研究条件没有饮酒差异。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 针对具有MA依赖的人。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，改善空间有限。该应用的主要目标是测试IMI对当前酒精依赖的妇女的功效。招募更严重的饮酒妇女样本将使研究条件之间的差异更大。为了评估持续改进的趋势是否持续了6个月，我们将在12个月时采访女性。该样本将由220名随机分配给IMI（9次会议）和 /或SMI（1次会议加8个营养教育课程以达到研究条件的时间等效的女性）。在两个研究条件下的所有参与者都将获得3种认知行为 每周咨询小组。该研究对NIAAA发出的PA-10-100响应PA-10-100“酒精使用障碍：治疗，服务研究和恢复”（R01）。我们的建议通过提出一项II期随机临床试验来解决此公告的优先事项，该试验将将IMI与依赖酒精的女性进行比较。该研究还旨在响应PA的呼吁评估变化机制的研究。与以前对MI的许多研究不同，我们将采用有限的排除标准，并将招募一些共存的药物和精神疾病的参与者。因此，该研究回应了PA关于合并症研究的呼吁。程序将从我们当前成功的RCT评估IMI的MA依赖性中获取。当前研究的成功方面包括实现招聘目标，对手册和研究协议的良好遵守以及出色的随访率（> 90％）。拟议的研究将在加利福尼亚州拉斐特的New Leaf治疗中心与当前的研究相同的门诊治疗计划进行。主要结果将是在基线和2、6和12个月时评估饮酒和酒精问题的措施。次要结果将包括成瘾的严重程度指数，精神病问题和创伤症状。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。