MBSR for fibromyalgia: A dose-finding study

MBSR 治疗纤维肌痛：剂量探索研究

• 批准号: 8299277
• 负责人: Ather Ali
• 金额: $ 13.29万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8299277
• 关键词: Adherence; Adverse effects; Advisory Committees; Affect; Algorithms; Area; Award; Chronic; Chronic Fatigue Syndrome; Chronic stress; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Commit; Complementary and alternative medicine; Consensus; Continuing Education; Coupled; Data; Data Quality; Depressed mood; Development Plans; Dose; Effectiveness; Ensure; Environment; Epidemiology; Equipment and supply inventories; Etiology; Evaluation; Evaluation Studies; Faculty; Fatigue; Fellowship; Fibromyalgia; Frequencies; Future; General Population; Goals; Home environment; Hour; Human; Institution; Instruction; Integrative Medicine; Intervention; Intervention Studies; Interview; Irritable Bowel Syndrome; K-Series Research Career Programs; Kentucky; Lyme Disease; Measures; Meditation; Mentors; Mentorship; Mind-Body Intervention; Muscle; National Research Service Awards; Neurosciences; Outcome Measure; Outpatients; Pain; Patient Education; Patients; Pattern; Pharmacotherapy; Physical Function; Physicians; Population; Prevalence; Protocols documentation; Public Health; Qualifying; Quality of life; Questionnaires; Randomized; Regimen; Research; Research Methodology; Research Personnel; Research Training; Resistance; Resources; Role; SF-36; Safety; Sick Building Syndrome; Sleep disturbances; Somatoform Disorders; Strategic Planning; Stress; Support Groups; Symptoms; Syndrome; Time; Training; Trauma; Treatment Protocols; Treatment outcome; United States; Universities; Visit; Visual Analogue Pain Scale; Work; active control; arm; base; career; career development; chronic pain; chronic widespread pain; clinical practice; clinically significant; compliance behavior; conventional therapy; design; efficacy trial; evidence base; experience; group support; high standard; improved; innovation; insight; lectures; medical schools; meetings; mindfulness; mindfulness-based stress reduction; programs; psychologic; research and development; research clinical testing; responsible research conduct; skills; statistics; symposium

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.

描述（由申请人提供）：候选人是一位接受过综合医学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、培训和指导将在耶鲁大学医学院进行，该学院拥有丰富的智力、教育和机构资源，以及创新研究的丰富学术环境。候选人将与热情、忠诚且卓有成就的导师和顾问团队（包括一些来自其他机构的具有专业知识并致力于他的研究和职业发展的人）一起工作，并受益于强大的机构和部门支持，以促进完成这项指导职业发展奖。教学培训将在整个奖励期间进行，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）每周针对耶鲁大学医学院初级教师的研究进展会议、研讨会和讲座。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。此 K23 应用程序的研究重点是针对纤维肌痛患者流行的身心疗法（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）MBSR 与主动对照相比的益处。 MBSR 是一种标准化的身心干预措施，涉及冥想、患者教育和团体支持。为期八周的 MBSR 方案包括每周 2.5 小时的指导和每日 30-45 分钟的自我练习。初步研究表明 MBSR 对于缓解纤维肌痛症状有好处，但还没有精心设计的试验评估最佳剂量。拟议的研究将开始对 MBSR 在纤维肌痛治疗中的作用进行一系列调查，系统评估剂量、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 纤维肌痛患者为期八周的 MBSR 疗程的治疗方案。这将通过以下方式完成： 1. 与纤维肌痛患者的积极对照相比，评估三种 MBSR 方案的安全性、可行性和依从性。 2. 通过经过验证的结果指标的变化来评估三种 MBSR 方案对纤维肌痛患者的临床益处。由于 CAM 干预措施的临床试验中的剂量通常是根据流行的实践模式推断的（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临床试验无效的结果。本研究的目的是获得对影响程度的估计，以便未来的试验能够以适当的统计功效进行设计。该研究将评估非药物 CAM 干预的三种“剂量”，以确定纤维肌痛患者为期八周的 MBSR 疗程的最佳实际剂量。这是第一个正式的 MBSR 剂量探索研究。它将利用标准的、经过验证的疼痛、身体功能、生活质量和正念测量方法，以及主动控制干预。它将为更大、更明确的 R01 提交提供高质量数据。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分级、逐步 CAM/综合医学算法的第一步。该应用程序的目标与 NCCAM 强调治疗慢性疼痛和战略计划目标一致，即“支持身心干预的临床评估和干预研究”和“支持高质量的研究培训和职业发展机会，以增加数量、质量，以及 CAM 研究人员的多样性。”候选人将定期与他的导师和咨询委员会会面，以确保持续进步并遵守培训、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医生研究员。 公共健康相关性：拟议研究的结果将提供关于治疗纤维肌痛的基于正念的减压的最佳剂量的见解，从而导致未来使用“优化”剂量的研究。确定有效缓解纤维肌痛症状的实用且可复制的 MBSR 剂量有可能使数百万纤维肌痛患者受益。