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）：我们正在进行的针对甲基苯丙胺（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，即有酒精问题的女性（N=87）如果被分配到IMI条件而不是标准MI （SMI）比较条件，她们的饮酒量会显著减少。在4个月和6个月的随访中，患有IMI的女性酒精问题的减少幅度更大。有趣的是，轨迹显示在治疗期间和治疗后饮酒问题持续下降，在4个月（p< 0.05）和6个月（p< 0.01）随访期间，研究条件之间的差异越来越大。6个月时的治疗效果为中等到较大，Cohen’s d=0.63。在不同的研究条件下，男性的饮酒量没有差异。就研究干预对饮酒的影响而言，当前样本的一个重要限制是目前的研究