MBSR for fibromyalgia: A dose-finding study

描述(申请人提供)：候选人是一名自然疗法医生，受过综合医学和流行病学方面的培训，完成了NRSA博士后奖学金(F32)，专注于补充医学和替代医学(CAM)的临床试验。候选人的长期职业目标是成为一名独立的临床调查员，专注于对纤维肌痛的循证CAM疗法进行严格评估和整合。研究、培训和指导将设在耶鲁大学医学院，拥有丰富的智力、教育和机构资源，以及丰富的创新研究学术环境。应聘者将与热情、忠诚和高度成功的导师和顾问团队合作(包括来自其他机构的一些对他的研究和职业发展具有专业知识和承诺的人)，并受益于强有力的机构和部门支持，以促进完成这一导师式的职业发展奖。授课培训将在整个获奖期间进行，包括临床研究方法、统计学、混合方法研究、心身医学和神经科学的高级课程。候选人将定期出席(并出席)耶鲁医学院以初级教员为重点的每周进行中的研究会议、研讨会和讲座。负责任的研究行为培训将通过耶鲁人类研究保护计划的指导和继续教育继续进行。K23应用程序的研究重点是对一种流行的心身疗法(基于正念的压力减轻；MBSR)进行剂量发现研究，用于纤维肌痛患者。它将调查不同“剂量”(高、标准和低剂量)的MBSR与主动对照的益处。MBSR是一种标准化的身心干预，包括冥想、患者教育和团体支持。为期8周的MBSR方案包括每周2.5小时的指导和每天30-45分钟的自我练习。初步研究表明，MBSR对缓解纤维肌痛症状有好处，尽管没有设计良好的试验评估最佳剂量。这项拟议的研究将开始一系列关于MBSR在纤维肌痛治疗中的作用的研究，系统地评估剂量、可行性、依从性和初步疗效。这项研究的目的是确定最佳的实际剂量和治疗方法。 纤维肌痛患者进行为期8周的MBSR疗程。这将通过以下方式完成：1.评估三种MBSR方案与积极对照治疗纤维肌痛患者的安全性、可行性和依从性。2.评估三种MBSR方案在纤维肌痛患者中的临床益处，通过验证结果指标的变化来衡量。由于CAM干预措施的临床试验中的剂量通常是从流行的实践模式(剂量基于轶事证据)推断出来的，因此临床试验中可能会出现第二类错误导致的无效结果。这项研究的目的是获得对效应大小的估计，以便将来的试验可以设计成具有适当的统计能力。这项研究将评估非药理性CAM干预的三种“剂量”，以确定对纤维肌痛患者进行为期8周的MBSR疗程的最佳实用剂量。这是第一次关于MBSR的正式剂量发现研究。它将使用标准的、经过验证的疼痛、身体功能、生活质量和正念测量，以及积极的控制干预。它将为更大、更明确的R01提交提供高质量的数据。这项初步研究的结果将是开发用于治疗纤维肌痛的循序渐进的CAM/综合医学算法的第一步。这一应用程序的目标与NCCAM对治疗慢性疼痛的重视以及战略计划的目标一致，即“支持心理/身体干预的临床评估和干预研究”，以及“支持高质量的研究培训和职业发展机会，以增加CAM研究人员的数量、质量和多样性。”应聘者将定期与他的导师和咨询委员会会面，以确保持续的进步和对培训、研究和职业发展计划的坚持。这将有助于确保一个富有成效的职业发展时期，并提供技能、经验和指导，以促进成为专注于纤维肌痛、CAM和综合医学干预的独立临床医生和研究人员。

DESCRIPTION (provided by applicant): The candidate is a naturopathic physician trained in integrative medicine and epidemiology who completed an NRSA Postdoctoral Fellowship (F32) focused on clinical trials in Complementary and Alternative Medicine (CAM). The candidate's long-term career goal is to become an independent clinical investigator focusing on rigorous evaluation and integration of evidence-based CAM therapies for fibromyalgia. The research, training, and mentorship will be based at the Yale University School of Medicine, with abundant intellectual, educational, and institutional resources, and a rich scholarly environment for innovative research. The candidate will work with an enthusiastic, committed, and highly accomplished team of mentors and advisors (including some from other institutions with expertise and commitment to his research and career development), and benefits from robust institutional and departmental support to facilitate completion of this mentored career development award. Didactic training will occur throughout the period of the award, including advanced courses on clinical research methods, statistics, mixed-methods research, mind-body medicine, and neuroscience. The candidate will regularly attend (and present at) weekly research in progress conferences, seminars, and lectures focused on junior faculty at the Yale School of Medicine. Training in the Responsible Conduct of Research will continue through mentorship and continuing education by the Yale Human Research Protection Program. The focus of the research in this K23 application is a dose-finding study of a popular mind-body therapy (Mindfulness-based Stress Reduction; MBSR) for patients with fibromyalgia. It will investigate the benefit of different "doses" (high, standard, and low) of MBSR compared with an active control. MBSR is a standardized mind-body intervention that involves meditation, patient education, and group support. The eight-week MBSR protocol involves 2.5 hours of weekly instruction and 30-45-minutes of daily self-practice. Preliminary studies suggest benefit of MBSR for the alleviation of fibromyalgia symptoms, though no well-designed trials have assessed optimal dosing. The proposed study will begin a line of inquiry into the role of MBSR for the treatment of fibromyalgia systematically assessing dosing, feasibility, adherence, and preliminary efficacy. The aim of this study is to identify the optimal practical dose and treatment regimen of an eight-week course of MBSR in patients with fibromyalgia. This will be completed by: 1. Assessing the safety, feasibility, and adherence profile of three regimens of MBSR compared with an active control in patients with fibromyalgia. 2. Assessing the clinical benefits of three regimens of MBSR in patients with fibromyalgia measured by changes in validated outcome measures. As dosing in clinical trials of CAM interventions are often extrapolated from prevailing practice patterns (with doses based on anecdotal evidence), null results in clinical trials due to type two errors can occur. The purpose of this study is to obtain estimates of the magnitude of effect so that future trials can be designed with appropriate statistical power. The study will assess three 'doses' of a non pharmacological CAM intervention to determine an optimal practical dose of an eight-week course of MBSR in patients with fibromyalgia. This is the first formal dose-finding study on MBSR. It will utilize standard, validated measures of pain, physical function, quality of life, and mindfulness, as well as an active control intervention. It ill provide high-quality data for a larger, more definitive R01 submission. Results obtained from this initial study will be the first step in developing a graduated, stepwise CAM/integrative medicine algorithm for the treatment of fibromyalgia. The goals of this application are consistent with NCCAM's emphasis on treating chronic pain and Strategic Plan goals to "support clinical evaluation and intervention studies of mind/body interventions" and "support high-quality research training and career development opportunities to increase the number, quality, and diversity of CAM researchers." The candidate will regularly meet with his mentor and advisory committee to ensure consistent progress and adherence to the training, research, and career development plan. This will help ensure a productive period of career development, and provide the skills, experience, and guidance in order to advance to an independent clinician-researcher focused on fibromyalgia, CAM, and integrative medicine interventions.