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

基于计算机的酒精使用障碍 CBT 培训的第一阶段研究

基本信息

批准号：
8503575
负责人：
KATHLEEN M. CARROLL
金额：
$ 18.97万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-05 至 2014-12-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8503575
关键词：
Address Alcohol consumption Alcohol dependence Alcohols Back Behavior Therapy Behavioral Benchmarking Case Management Characteristics Clinical Cognitive Therapy Computer Assisted Computer-Assisted Therapy Coping Skills Counseling Dependence Development Drug Addiction Drug usage Enhancers Evaluation Evidence based treatment Exploratory/Developmental Grant Funding Heavy Drinking Illicit Drugs Individual Interview Measures Mediator of activation protein Methods Monitor National Institute on Alcohol Abuse and Alcoholism Online Systems Outcome Outcome Measure Outpatients Participant Population Program Development Program Evaluation Public Health Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Research Safety Security Specific qualifier value Specificity Staging Testing Time TimeLine Training Treatment Cost Underserved Population alcohol abuse therapy alcohol use disorder base clinical practice computer assisted patient care computer studies design drinking evidence base follow-up meetings novel primary outcome programs psychosocial randomized trial secondary outcome standard care three-arm study treatment effect treatment strategy virtual web site

项目摘要

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).

描述(由申请人提供)：计算机辅助治疗具有巨大的潜力，可以使基于证据的治疗更广泛地提供给那些可能从中受益的人，标准化治疗提供，延长和解放忙碌的临床医生的时间，并降低治疗成本。然而，尽管有巨大的希望，计算机辅助治疗的良好控制的随机临床试验仍然很少，更没有什么能达到评估临床医生提供的行为治疗的既定方法学标准的药物。我们已经开发了一种计算机辅助版本的CBT(CBT4CBT)，并证明了它作为门诊治疗非法药物依赖的辅助手段的有效性、持久性和特异性。2009年，NIAAA与我们接洽，要求我们专门为有酒精使用障碍的个人开发CBT4CBT的网络版，因为目前还没有针对酒精使用障碍的全面计算机辅助CBT计划，证明了其有效性。通过ARRA的资助，基于网络的CBT4CBT酒精项目的开发于2011年完成，并在我们指定的时间表内完成。我们现在建议进行一项探索性的第一阶段研究，以评估该计划对寻求治疗的酒精依赖患者的可行性和初步疗效。我们建议对符合当前酒精依赖标准的90名寻求治疗的患者进行为期8周的随机临床试验。参与者将被随机分为三种情况之一：(1)标准门诊咨询，(2)咨询+CBT4CBT(作为标准咨询的附加网站提供，或(3)基于网络的CBT4CBT作为虚拟独立(CBT4CBT+最低临床监测))。这种设计对于阶段1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)对该计划进行评估。主要的结果衡量标准将是减少饮酒(禁酒天数、每周大量饮酒天数的百分比)。将使用治疗利用率和其他次要结果的衡量标准来评估基于网络的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、使用变化策略)。