Single Session Pain Catastrophizing Treatment: Comparative Efficacy & Mechanisms

 描述(申请人提供)：慢性下腰痛(CLBP)是最常见的慢性疼痛状况，也是美国残疾的第二大原因。疼痛灾难(PC)--对实际或预期疼痛做出负面认知-情绪反应的一种模式--与CLBP的发展和维持以及残疾显著相关。PC破坏了CLBP治疗，从而助长了治疗无效和浪费支出的循环。虽然认知行为疗法(Pain-CBT)治疗的是PC，但团体治疗涉及6-10个疗程，因此造成了大量的时间、旅行和成本负担。因此，迫切需要开发和传播有效、低成本的治疗方法。 这特别减少了个人电脑。因此，我们开发了一个单疗程、2小时的疼痛-CBT课程，仅治疗PC(“从灾难到恢复”；FCR)。我们的试验数据显示，在慢性疼痛样本中，FCR的效果规模较大，在医疗和心理领域方面的结果优于“照常治疗”匹配的临床队列。我们建议在231名CLBP患者中进行三臂疗效比较RCT，比较：(A)FCR，(B)健康教育对照组，(C)8节疼痛-CBT课程。我们的主要终点是治疗3个月后的PC，次要终点是治疗6个月后的PC。我们假设，在通过我们的PROMIS平台测量的PC和疼痛相关结果方面，FCR将优于主动控制，并且不逊于8次疼痛-CBT级。该应用程序的一个创新方面是我们建议开发和验证简短版本的每日PCS测量，并使用高频采样方法应用该测量来阐明PC的机制，并表征对积极干预的积极反应如何减少PC发作的影响。额外的新方法：我们的专业PROMIS平台；用于客观测量睡眠和活动的活动记录仪；以及定制的‘FCR Relation Resource’应用程序(Nexus 7平板电脑上)，以客观量化FCR组的技能使用情况。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两种积极治疗的应答者/非应答者进行详细的表型分析。我们将使用纵向时间范围内的每日评级来表征PC如何随治疗而变化，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：(1)“缓解慢性疼痛”，(2)在“真实世界环境”中研究我们的身心干预，以及(3)促进对PC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.