Computer Based Training in CBT for Spanish-Speaking Substance Users: Competitive Revision

 描述（由申请人提供）：这是一个竞争性修订版（即，R 01 DA 030369（针对西班牙语物质使用者的CBT计算机培训;主要研究者：卡罗尔; 2012年3月15日至2018年2月28日）的补充文件），该文件是为响应NIDA通知DA-14-049（确定减少非法药物使用是否与临床结局改善相关的研究的竞争性修订申请的资金可用性）而提交的。由于缺乏具有临床意义和广泛接受的治疗“成功”指标，可卡因使用治疗方面的进展受到不利影响。对可卡因使用试验的结果指标进行系统的实证评价很少，这在很大程度上是由于缺乏这类目的所需的专门数据集。为了响应这一通知，我们建议开发一个汇总数据集，其中包括2002-2014年间在耶鲁大学进行的7项针对可卡因使用障碍的独立随机临床试验中随机接受治疗的720名独特个体。对于所有研究，治疗期间药物使用的测量包括可卡因和其他药物使用的每日自我报告以及至少每周收集的尿液毒理学筛查。随访访谈包括在治疗结束后1个月、3个月、6个月和12个月收集的广泛的自我报告和尿液毒理学筛查，每个治疗队列收集80-99%的数据。这一庞大且独特完整的数据集将提供足够的能力来应用纵向混合模型和其他分析方法，以评估治疗期间可卡因使用的减少与改善的功能（例如，健康、社会、经济）、心理社会和其他健康相关结果，最终目标是确定临床上有用和有效的治疗成功结果指标。功能结果将包括多个生活领域的问题严重程度指数（例如，医学、法律的、就业、精神病学），以及潜在的“有临床意义的结果”的几个候选者的综合衡量。纵向混合模型将用于采取以人为中心的方法来检查多个时间点参与者之间的共同变化模式（即，可卡因使用轨迹）。

 DESCRIPTION (provided by applicant): This is a competitive revision (i.e., supplement) for R01DA030369 (Computer Based Training in CBT for Spanish-Speaking Substance Users; Principal Investigator: Carroll; 3/15/12 - 2/28/18) submitted in response to NIDA Notice DA-14-049 (Availability of Funds for Competitive Revision Applications for Research to Determine if Reduction in Illicit Drug use is Associated with Improvement in Clinical Outcomes). Progress in the treatment for cocaine use has been negatively impacted by the lack of clinically meaningful and broadly accepted indicators of treatment `success'. Systematic empirical evaluations of outcome indicators for cocaine use trials are rare, in large part due to the lack of specialized datasets required for such purposes. In response to this Notice, we propose to develop a pooled dataset of 720 unique individuals randomized to treatment in one of 7 independent randomized clinical trials targeting cocaine use disorders conducted at Yale between 2002-2014. For all studies, measures of drug use within treatment include daily self-reports of cocaine and other drug use as well as urine toxicology screens collected at least weekly. Follow-up interviews include both extensive self-report and urine toxicology screens collected at 1, 3, 6, and 12 months after the end of treatment with data collected on 80-99% of each treatment cohort. This large and uniquely complete dataset will provide adequate power to apply longitudinal mixture models and other analytic approaches to evaluate relationships between reduction in cocaine use during treatment with improved functional (e.g., health, social, economic), psychosocial, and other health-related outcomes, with the ultimate goal of identifying clinically useful and valid outcome indicators of treatment success. Functional outcomes will include indices of problem severity across multiple life domains (e.g., medical, legal, employment, psychiatric), as well as combined measures of several candidates of potential `clinically meaningful outcomes'. Longitudinal mixture models will be used to take a person-centered approach to examining common patterns of change across participants over multiple time points (i.e., cocaine use trajectories).