Single Session Pain Catastrophizing Treatment: Comparative Efficacy & Mechanisms

 描述（由申请人提供）：慢性腰痛（CLBP）是最常见的慢性疼痛状况，是美国残疾的第二大原因。疼痛灾难化（PC）--对实际或预期疼痛的负面认知情绪反应模式--与CLBP的发展和维持以及残疾显著相关。PC破坏CLBP治疗，从而导致治疗无效和浪费支出的循环。虽然认知行为疗法（疼痛-CBT）治疗PC，但团体治疗涉及6-10个疗程，因此造成了时间，旅行和成本的巨大负担。因此，迫切需要开发和推广高效、低成本的治疗方法 特别是减少PC。因此，我们开发了一个单一的会话，2小时的疼痛CBT类，单独治疗PC（“从灾难到恢复”; FCR）。我们的试验数据显示，与“常规治疗”匹配的诊所队列相比，慢性疼痛样本中FCR的效应量较大，PROMIS领域的医疗和心理结局上级。我们建议在231例CLBP患者中进行3组疗效比较RCT，比较：（A）FCR，（B）健康教育对照，（C）8节疼痛CBT课程。我们的主要终点是治疗后3个月的PC，次要终点是治疗后6个月的PC。我们假设FCR在改善PC和疼痛相关结局方面上级主动控制，且不劣于8次疼痛CBT类，这些结果由我们的PROMIS平台测量。一个创新的方面的应用是我们的建议，开发和验证一个简短的版本每日PCS措施，并应用高频率采样方法的措施，以阐明PC的机制，并表征如何积极响应积极干预减少PC事件的影响。我们的专业PROMIS平台的其他新方法;用于客观睡眠和活动测量的活动记录仪;以及定制的“FCR放松资源”应用程序（在Nexus 7平板电脑上），以客观地量化FCR组的技能使用。我们丰富的数据集将允许使用机器学习和其他高级分析对积极治疗的应答者/无应答者进行详细的表型分析。我们将在纵向时间范围内使用每日评级来表征PC如何响应治疗而变化，以及PC对疼痛，睡眠，活动和其他变量的机械影响。我们的建议解决了NCCAM的优先事项，以（1）“缓解慢性疼痛”，（2）研究我们的身心干预在“现实世界的设置”，和（3）推进PC的机制的科学理解。

 DESCRIPTION (provided by applicant): Chronic low back pain (CLBP) is the most common chronic pain condition and is the second leading cause of disability in the U.S. Pain catastrophizing (PC)--a pattern of negative cognitive-emotional responses to actual or anticipated pain-is significantly associated with the development and maintenance of CLBP as well as disability. PC undermines CLBP treatments, thus contributing to a cycle of treatment futility and wasted expenditure. While Cognitive Behavioral Therapy (pain-CBT) treats PC, group treatment involves 6-10 sessions and thus poses substantial burdens of time, travel, and cost. Therefore, there is a critical need to develop and disseminate efficient, low-cost treatments that specifically reduce PC. Accordingly, we developed a single-session, 2-hour pain-CBT class that solely treats PC ("From Catastrophizing to Recovery"; FCR). Our pilot data revealed large effect sizes for FCR in a chronic pain sample and superior outcomes for medical and psychological across PROMIS domains, as compared to a 'treatment as usual' matched clinic cohort. We propose to conduct a 3-arm comparative efficacy RCT in 231 patients with CLBP comparing: (A) FCR, (B) a health education control, and (C) an 8-session pain-CBT class. Our primary endpoint is PC 3 months post- treatment and our secondary endpoint is PC 6 months post-treatment. We hypothesize that FCR will be superior to active control and non-inferior to the 8-session pain-CBT class for improving PC and pain-related outcomes measured by our PROMIS platform. An innovative aspect of the application is our proposal to develop and validate a brief version Daily PCS measure, and apply the measure with high frequency sampling methods to elucidate the mechanics of PC, and to characterize how positive response to active intervention reduces the influence of PC episodes. Additional novel methods our specialized PROMIS platform; actigraphy for objective sleep and activity measurement; and a customized 'FCR Relaxation Resource' app (on Nexus 7 tablets) to objectively quantify skills use in the FCR group. Our rich dataset will allow for detailed phenotyping of responders / non-responders for both active treatments using machine learning and other advanced analytics. We will use daily ratings across a longitudinal timeframe to characterize how PC changes in response to treatment, as well as the mechanistic influence of PC on pain, sleep, activity, and other variables. Our proposal addresses the NCCAM priorities to (1) "alleviate chronic pain", (2) study our mind-body intervention in a "real-world setting," and (3) advance scientific understanding of the mechanisms of PC.