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

 说明(由申请人提供)：这是对R01DA030369(针对西班牙语药物使用者的计算机CBT培训；主要调查员：Carroll；3/15/12-2/28/18)的竞争性修订(即，附录)，是对NIDA通知DA-14-049(为确定非法药物使用的减少是否与临床结果的改善相关的研究竞争性修订申请的资金可用性)而提交的。由于缺乏临床上有意义和被广泛接受的治疗“成功”指标，可卡因使用治疗方面的进展受到了负面影响。对可卡因使用试验的结果指标进行系统的经验评估的情况很少，这在很大程度上是因为缺乏这类目的所需的专门数据集。作为对这一通知的回应，我们建议开发一个包含720名独特个体的汇集数据集，这些个体在2002-2014年间在耶鲁大学进行的针对可卡因使用障碍的7项独立随机临床试验之一中随机接受治疗。在所有研究中，对治疗中药物使用的衡量包括每天对可卡因和其他药物使用的自我报告，以及至少每周收集一次的尿毒学筛查。后续访谈包括广泛的自我报告和在治疗结束后1、3、6和12个月收集的尿毒学筛查，收集了每个治疗队列中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来评估治疗期间可卡因使用量的减少与改善的功能(例如，健康、社会、经济)、心理社会和其他与健康相关的结果之间的关系，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(例如，医疗、法律、就业、精神病学)的问题严重程度指数，以及潜在的“有临床意义的结果”的几个候选者的综合衡量。纵向混合模型将被用来采取以人为中心的方法来检查参与者在多个时间点上的共同变化模式(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).