MBSR for fibromyalgia: A dose-finding study

描述（由申请人提供）：候选人是一名接受过中西医结合和流行病学培训的自然疗法医师，完成了NRSA博士后奖学金（F32），专注于补充和替代医学（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研究者，专注于严格评估和整合纤维肌痛的循证CAM疗法。研究、培训和指导将以耶鲁大学医学院为基础，该学院拥有丰富的智力、教育和机构资源，并为创新研究提供丰富的学术环境。候选人将与一个热情、忠诚、成就卓著的导师和顾问团队（包括一些来自其他机构的专业知识和对他的研究和职业发展的承诺）一起工作，并受益于强有力的机构和部门支持，以促进这项指导职业发展奖的完成。教学培训将在整个奖项期间进行，包括关于临床研究方法、统计学、混合方法研究、身心医学和神经科学的高级课程。候选人将定期参加（并出席）每周一次的研究进展会议、研讨会和以耶鲁大学医学院初级教员为重点的讲座。负责任的研究行为培训将通过耶鲁大学人类研究保护计划的指导和继续教育继续进行。这项K23应用的研究重点是对纤维肌痛患者的一种流行的身心疗法（正念减压；MBSR）的剂量发现研究。它将调查不同“剂量”（高、标准和低）的正念减压减压与主动对照相比的益处。正念减压疗法是一种标准化的身心干预，包括冥想、病人教育和团体支持。为期八周的正念减压疗法包括每周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，正念减压疗法有利于减轻纤维肌痛症状，尽管没有精心设计的试验评估最佳剂量。拟议的研究将开始对正念减压疗法在纤维肌痛治疗中的作用进行系统评估，评估剂量、可行性、依从性和初步疗效。本研究的目的是确定最佳的实用剂量和治疗方法

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.