MBSR for fibromyalgia: A dose-finding study

描述（由申请人提供）：候选人是一名自然疗法医生，接受过中西医结合和流行病学培训，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，专注于纤维肌痛循证CAM疗法的严格评估和整合。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，以及丰富的学术环境，为创新研究。候选人将与一个热情，承诺和高度成就的导师和顾问团队（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）合作，并从强大的机构和部门支持中受益，以促进完成这一指导职业发展奖。教学培训将在整个奖项期间进行，包括临床研究方法，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，研讨会和讲座，重点是耶鲁大学医学院的初级教师。在负责任的研究行为的培训将继续通过指导和耶鲁大学人类研究保护计划的继续教育。这项K23应用的研究重点是对纤维肌痛患者进行流行的身心疗法（基于正念的减压; MBSR）的剂量探索研究。它将研究不同“剂量”（高，标准和低）的正念减压疗法与积极控制相比的益处。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，正念减压疗法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。拟议的研究将开始对正念减压疗法治疗纤维肌痛的作用进行系统的调查，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际剂量和治疗 在纤维肌痛患者中进行为期八周的正念减压疗法。这将通过以下方式完成：1.在纤维肌痛患者中评估三种正念减压治疗方案与活性对照的安全性、可行性和依从性。 2.评估三种正念减压疗法对纤维肌痛患者的临床获益，通过有效结局指标的变化来衡量。由于CAM干预的临床试验中的剂量通常是从流行的实践模式中推断出来的（剂量基于轶事证据），因此可能会出现由于第二类错误而导致的临床试验无效结果。本研究的目的是获得效应大小的估计值，以便未来的试验可以设计适当的统计功效。该研究将评估三种非药物CAM干预的“剂量”，以确定纤维肌痛患者八周MBSR疗程的最佳实用剂量。这是第一个正式的正念减压疗法剂量探索研究。它将利用标准的，经过验证的疼痛，身体功能，生活质量和正念的测量，以及主动控制干预。它将为更大、更明确的R 01提交提供高质量的数据。从这项初步研究中获得的结果将是开发用于治疗纤维肌痛的渐进式CAM/中西医结合算法的第一步。该申请的目标与NCCAM对治疗慢性疼痛的重视和战略计划目标一致，以“支持临床评估和身心干预的干预研究”和“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。“候选人将定期与他的导师和咨询委员会会面，以确保持续的进展和遵守培训，研究和职业发展计划。这将有助于确保职业发展的富有成效的时期，并提供技能，经验和指导，以便晋升为专注于纤维肌痛，CAM和综合医学干预的独立临床研究人员。 公共卫生相关性：拟议研究的结果将提供有关治疗纤维肌痛的基于正念的压力减轻的最佳剂量的见解，从而导致未来使用“优化”剂量的研究。确定一个实用的和可复制的剂量的正念减压疗法，是有效的缓解纤维肌痛症状有可能受益于数百万人患有纤维肌痛。

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. PUBLIC HEALTH RELEVANCE: Results from the proposed research will provide insights about optimal dosing of mindfulness-based stress reduction for the treatment of fibromyalgia, leading to future studies using an 'optimized' dose. The identification of a practical and replicable dose of MBSR that is effective for the alleviation of fibromyalgia symptoms has the potential to benefit the millions of people suffering from fibromyalgia.