Dismantling the Components and Dosing of CBT for Co-Occurring Disorders

描述（由申请人提供）：这是最近完成的“父”R 01（AA 015069：“CBT治疗共病酒精中毒者的焦虑症”）的竞争性续期申请。多达一半的酒精使用障碍（AUD）治疗患者患有并发的焦虑症，这些患者复发饮酒的速度是其他患者的两倍。为了解决这个问题，父母R 01评估了一个基于CBT的计划，该计划将三个阶段的跨诊断焦虑减少治疗与三个阶段相结合，这三个阶段旨在将焦虑与饮酒联系起来的认知和行为联系脱钩（例如，期望，应对饮酒动机，条件联想）。在一项超过300例病例的随机试验中，R 01表明，将这种CBT添加到基于住宅社区的AUD治疗中显著改善了四个月的酒精结果（例如，41%复发），与添加减压对照治疗（53%复发）和单独接受AUD治疗的匹配非随机队列（61%复发）相比。虽然这证实了母研究R 01中的主要研究假设，但必须承认，其影响并不大，CBT仅缓解了与合并焦虑症相关的复发风险增加的一半左右。幸运的是，亲本R 01的结果也为可能显着提高CBT治疗效果的修饰指明了方向。具体而言，父母R 01的发现模式表明，解偶联治疗，而不是焦虑减轻治疗，导致改善的酒精结果。这表明进一步强调解耦治疗元素将增加CBT的整体有效性;然而，减少焦虑对改善这些患者的酒精结果的重要性仍然不明确。例如，三次用于减少焦虑的会议可能不足以影响父母R 01的酒精结果。或者，可能需要减少焦虑的治疗与解耦治疗协同工作，以改善酒精的结果。更新工作将使用拆除方法来隔离这些治疗组分在两个剂量水平下的单独和相互作用，以提高经验证但仍表现不佳的有效性 CBT的父R 01版本。将350名患有焦虑症的AUD患者随机分配至接受以下治疗的组：1）六次CBT焦虑减轻治疗（CBT-AR）; 2）六次CBT焦虑-酒精脱耦治疗（CBT-DC）;或3）原始CBT及其三次焦虑减轻治疗和三次脱耦治疗（CBT-O）。基于R 01的研究结果表明，解耦成分是CBT治疗的有效成分，我们预测CBT-DC组（6次DC治疗）将获得最佳的酒精治疗结果，然后是CBT-O（3次DC治疗），再然后是CBT-AR（0次DC治疗）。如果CBT-O的表现优于其他两组，该设计还将表明AR和DC CBT组件之间的协同效应。

DESCRIPTION (provided by applicant): This is a competitive renewal application for the recently completed "parent" R01 (AA015069: "CBT Treatment for Anxiety Disorder in Comorbid Alcoholics"). Up to half of patients in treatment for an alcohol use disorder (AUD) have a co-occurring anxiety disorder and these patients relapse to drinking at twice the rate of other patients. To address this, the parent R01 evaluated a CBT-based program that combined three sessions of trans-diagnostic anxiety reduction therapy with three sessions designed to de-couple the cognitive and behavioral bonds linking anxiety to alcohol use (e.g., expectancies, coping drinking motives, conditioned associations). In a randomized trial with over 300 cases, the parent R01 showed that adding this CBT to a residential community-based AUD treatment significantly improved four-month alcohol outcomes (e.g., 41% relapsed) compared to adding a stress reduction control treatment (53% relapsed) and compared to a matched, non-randomized cohort undergoing the AUD treatment alone (61% relapsed). While this confirmed the primary study hypotheses in the parent R01, it must be acknowledged that the effects were not large and that the CBT alleviated only about half of the increased relapse risk associated with co- occurring anxiety disorders. Fortunately, the results of the parent R01 also point the way to modifications that are likely to significantly increase the therapeutic effect of the CBT. Specifically, the pattern of findings in the parent R01 indicates that the de-coupling therapy, rather than the anxiety reduction therapy, caused the improved alcohol outcomes. This suggests that further emphasizing the de-coupling therapy elements would increase the CBT's overall effectiveness; however, the importance of anxiety reduction for improving alcohol outcomes in these patients remains ambiguous. For example, the three sessions devoted to anxiety reduction may have been insufficient to affect alcohol outcomes in the parent R01. Alternatively, anxiety reduction therapy may be needed to work synergistically with de-coupling therapy to improve alcohol outcomes. The renewal work would use a dismantling approach to isolate the separate and interactive effects of these therapy components at two dose levels toward the goal of increasing the effectiveness of the validated but still sub-optimally performing parent R01 version of the CBT. 350 AUD patients with an anxiety disorder would be randomized to groups receiving either: 1) six sessions of CBT for anxiety reduction (CBT- AR); 2) six sessions of CBT for anxiety-alcohol de-coupling (CBT-DC); or, 3) the original CBT with its three anxiety reduction sessions and three de-coupling sessions (CBT-O). Based on the parent R01 findings indicating that the de-coupling components are the active ingredients of the CBT therapy, we predict that the best alcohol outcomes will be obtained in the CBT-DC group (six DC sessions) followed by the CBT-O (three DC sessions) further followed by the CBT-AR (zero DC sessions). This design would also indicate synergy effects between the AR and DC CBT components if the CBT-O out-performs the other two groups.