Modified Behavioral Treatment for Cocaine Patients with Cognitive Deficits

描述（由申请人提供）：超过50%的药物依赖治疗患者患有认知缺陷。我们和其他人已经表明，在注意力、记忆力和执行功能等领域的这些缺陷预测了标准行为治疗（如认知行为复发预防（CBT-RP））中物质依赖患者的治疗保留和结果。CBT是有效的，广泛用于治疗可卡因和其他物质依赖，重要的是，它具有持久的效果，但辍学率仍然很高。这种治疗不是专门设计来适应认知障碍，它们对患者提出了相当大的认知要求，例如，要求患者主要通过教学演示来吸收和保留会话内容，并学习和练习新技能以科普高风险情况。这表明，行为治疗的结果可以通过修改治疗来改善，以适应药物依赖患者中通常观察到的缺陷。在这次重新提交的报告中，我们提出了一个第一阶段行为疗法开发项目，以修改CBT，使用其他治疗环境中的循证方法来弥补认知缺陷。在IA阶段，将开发修改的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得到调整。随后的IB期随机对照12周试验将提供M-CBT（N=64）在治疗可卡因依赖患者方面是否上级标准CBT（N=64）的初步测试以及效应量估计。将入组有和无认知缺陷的患者，以探索M-CBT效应是普遍的，还是对认知障碍患者具有特异性。主要结局将是12周治疗期间和长期随访期间的治疗保留和药物使用结局。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，希望这种方法将导致CBT对可卡因依赖的疗效的实质性改善，并将提出一种新的策略，用于改善一系列行为治疗和物质依赖类型的结果。

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.