Modified Behavioral Treatment for Cocaine Patients with Cognitive Deficits

描述（由申请人提供）：超过50%的进入药物依赖治疗的患者患有认知缺陷。我们和其他人已经表明，在诸如注意力、记忆和执行功能等领域，这些缺陷预示着药物依赖患者在标准行为治疗（如认知-行为复发预防（CBT-RP））中的治疗保留和结果不佳。CBT是有效的，广泛用于治疗可卡因和其他物质依赖，而且，重要的是，显示出持久的效果，但辍学率仍然很高。这种治疗并不是专门为适应认知障碍而设计的，它们对患者提出了相当大的认知要求，例如，要求患者主要通过说教式的演讲来吸收和记住治疗内容，并学习和练习新的技能来应对高风险情况。这表明，行为治疗的结果可以通过修改治疗以适应在药物依赖患者中典型观察到的缺陷而得到改善。在这篇再次提交的文章中，我们提出了一个第一阶段的行为治疗发展项目来修改CBT，使用其他治疗设置的基于证据的方法来补偿认知缺陷。在IA阶段，将开发改进的CBT治疗手册（M-CBT）的原型，并在20名可卡因依赖患者的非对照试验中进行测试。培训治疗师和衡量治疗依从性的方法也将进行调整。随后的IB期随机、对照、12周的试验将提供M-CBT （N=64）是否优于标准CBT （N=64）治疗可卡因依赖患者的初步测试，以及效应大小的估计。有认知缺陷和无认知缺陷的患者将被纳入研究，以探讨M-CBT的效果是普遍的，还是仅针对有认知障碍的患者。在12周的治疗和长期随访期间，主要结果将是治疗和药物使用结果的保留。如果有希望，M-CBT治疗手册，以及相关的培训和监测方法，将为后续的II期或III期试验提供基础。最终，我们希望这一方法能够大大提高CBT治疗可卡因依赖的疗效，并为改善一系列行为治疗和物质依赖类型的结果提供一种新的策略。

DESCRIPTION (provided by applicant): Over 50% of patients entering treatment for substance dependence suffer from cognitive deficits. We and others have shown that these deficits, in domains such as attention, memory, and executive functioning, predict poor treatment retention and outcome in substance dependent patients in standard behavioral treatments such as Cognitive-Behavioral Relapse Prevention (CBT-RP). CBT is efficacious, widely used for treatment of cocaine and other substance dependencies, and, importantly, shown to have lasting effects, but dropout rates remain high. Such treatments are not specifically designed to accommodate cognitive impairments, and they place considerable cognitive demands on patients, who are asked, for example, to absorb and retain session content largely through didactic presentation, and learn and practice new skills to cope with high risk situations. This suggests that the outcome of behavioral treatment could be improved by modifying the treatment to accommodate the deficits typically observed in drug dependent patients. In this re-submission, we propose a Stage I Behavior Therapy Development Project to modify CBT, using evidence- based methods from other treatment settings to compensate for cognitive deficits. In Stage IA, a prototype of the modified CBT treatment manual (M-CBT) will be developed and tested in an uncontrolled trial with 20 cocaine dependent patients. Methods for training therapists and measuring treatment adherence will also be adapted. A subsequent Stage IB randomized, controlled, 12-week trial will provide an initial test of whether M-CBT (N=64) is superior to standard CBT (N=64) for treatment of cocaine dependent patients as well as an estimate of effect size. Patients with and without cognitive deficits will be entered to explore whether M-CBT effects are general, or specific to patients with cognitive impairments. Principal outcomes will be retention in treatment and drug use outcome, both during the 12 weeks of treatment and during long-term follow-up. If promising, the M-CBT treatment manual, and associated training and monitoring methods, will provide the basis for subsequent Stage II or III trials. Ultimately, it is hoped that this approach will lead to substantial improvements in the efficacy of CBT for cocaine dependence, and will suggest a new strategy for improving outcome for a range of behavioral treatments and types of substance dependence.