A Stage I Study of Computer Based Training in CBT for Alcohol Use Disorders

描述（由申请人提供）：计算机辅助治疗具有巨大的潜力，可以使循证疗法更广泛地提供给可能从中受益的人，使治疗实施标准化，延长和释放忙碌的临床医生的时间，并降低治疗成本。然而，尽管前景广阔，计算机辅助疗法的对照良好的随机临床试验仍然很少，而且符合评估临床医生提供的行为疗法的既定方法标准的试验仍然很少。我们已经开发了一种计算机辅助的CBT（CBT4CBT），并证明了其有效性，持久性和特异性作为非法药物依赖门诊治疗的辅助手段。2009年，NIAAA与我们接洽，专门为酒精使用障碍患者开发基于网络的CBT4CBT版本，因为目前还没有针对酒精使用障碍的全面计算机辅助CBT程序。在ARRA的资助下，基于网络的CBT4CBT酒精项目的开发在我们指定的时间轴内于2011年完成。我们现在提出了一个探索性的，第一阶段的研究，以评估该计划的可行性和初步疗效与寻求治疗的酒精依赖的个人。我们建议进行一项为期8周的随机临床试验，90个寻求治疗的个人符合目前的标准酒精依赖。参与者将被随机分配到以下三种情况之一：（1）标准门诊咨询，（2）咨询加CBT4CBT（作为标准咨询的附加内容提供的网站），或（3）基于网络的CBT4CBT作为虚拟独立（CBT4CBT加最小临床监测）。这种设计对于第1阶段研究来说是新颖的，因为它将允许以两种最有可能在临床上实施的形式（附加和独立）评价该项目。主要结果指标将是酒精使用的减少（戒酒天数百分比，每周大量饮酒天数）。治疗利用率和其他次要结局的指标将用于评估基于网络的CBT4CBT是否保留了传统临床医生提供的CBT的关键特征（例如，获得应对技能，使用变革战略）。 公共卫生相关性：该项目建议进行一项探索性的第一阶段研究，以评估适用于酒精使用障碍患者的基于网络的认知行为疗法（CBT4CBT）的可行性和初步疗效。提供有效的计算机辅助酒精依赖治疗可以大大扩大治疗的范围，从而通过向服务不足的人口提供更多的治疗，对公共卫生产生重大影响。

DESCRIPTION (provided by applicant): Computer-assisted treatments have tremendous potential for making evidence based therapies more widely available to those who may benefit from them, standardizing treatment delivery, extending and freeing up the time of busy clinicians, and reducing the costs of treatment. Despite their enormous promise, however, well- controlled randomized clinical trials of computer-assisted therapies remain rare, and there are fewer still that would meet established methodological standards for the evaluation of clinician-delivered behavioral therapies. We have developed a computer-assisted version of CBT (CBT4CBT) and have demonstrated its efficacy, durability, and specificity as an adjunct to outpatient treatment for illicit drug dependence. In 2009, we were approached by NIAAA to develop a web-based version of CBT4CBT specifically for individuals with alcohol use disorders, as there are no existing full-scale computer-assisted CBT programs for alcohol use disorders with demonstrated efficacy. Funded through ARRA, development of the web based CBT4CBT alcohol program was completed in 2011, within our specified timeline. We now propose an exploratory, Stage I study to evaluate the program's feasibility and preliminary efficacy with treatment-seeking alcohol dependent individuals. We propose to conduct an 8-week randomized clinical trial with 90 treatment-seeking individuals meeting current criteria for alcoho dependence. Participants will be randomized to one of three conditions: (1) standard outpatient counseling, (2) counseling plus CBT4CBT (the website delivered as an add-on to standard counseling, or (3) web-based CBT4CBT as a virtual standalone (CBT4CBT plus minimal clinical monitoring). This design is novel for a Stage 1 study in that it will allow evaluation of the program in two of the forms in which it is most likely to be implemented clinically (add-on and stand alone). The primary outcome measures will be reduction in alcohol use (percent days abstinent, heavy drinking days by week). Measures of treatment utilization and other secondary outcomes will be used to evaluate whether web-based CBT4CBT retains key characteristics of traditional clinician-delivered CBT (e.g., acquisition of coping skills, use of change strategies). PUBLIC HEALTH RELEVANCE: This project proposes to conduct an exploratory, Stage 1 study to evaluate the feasibility and preliminary efficacy of a web-based version of Cognitive Behavioral Therapy (CBT4CBT) adapted for use by individuals with alcohol use disorders. The availability of an effective computer-assisted treatment for alcohol dependence could greatly broaden the availability of treatment and hence have a major impact on public health through making treatment more available to underserved populations.