Mindfulness and Migraine: A Randomized Controlled Trial

正念与偏头痛：随机对照试验

• 批准号: 9083632
• 负责人: Alice Rogot Pressman
• 金额: $ 61.64万
• 依托单位: CALIFORNIA PACIFIC MED CTR RES INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9083632
• 关键词: Address; Adult; Adverse effects; Affect; Algorithms; Behavior Therapy; California; Caring; Classification Scheme; Clinical; Clinical Trials; Comorbidity; Complex; Control Groups; Data; Disease; Effectiveness; Electronic Health Record; Enrollment; Epidemiologic Studies; Female; Frequencies; Functional disorder; Headache; Health; Health care facility; Health system; Heterogeneity; Intervention; Knowledge; Light; Massachusetts; Measures; Meditation; Mental Health; Methods; Migraine; Mind-Body Intervention; Moods; Outcome Measure; Pain; Pain Measurement; Participant; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Pilot Projects; Population; Probability; Provider; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Retrospective Studies; Severities; Site; Sleep; Subgroup; Techniques; Testing; Therapeutic Effect; Time; Training; Universities; Woman; Work; aged; base; burden of illness; clinical care; cost; demographics; design; diaries; disability; disability burden; effective therapy; experience; follow-up; group intervention; improved; innovation; interest; mindfulness; mindfulness-based stress reduction; nervous system disorder; pragmatic trial; primary outcome; public health relevance; response; secondary outcome; tool; treatment as usual; treatment effect; treatment response

 DESCRIPTION (provided by applicant): Migraine, one of the most common neurological disorders in the U.S., is ranked among the top 20 causes of disability worldwide. Migraine is currently one of the leading causes of disease burden for women aged 15-44 years and affects an estimated 11% of the adult population globally, with a strong female predominance. Current approaches to therapy are primarily medication-based but are limited by often- inadequate effectiveness, high costs for many migraine-specific medications, and common side effects. In addition, there likely exist subtypes of migraine that may affect the likelihood of response to treatment, but these have been poorly investigated to-date. Furthermore, many patients are interested in exploring alternatives to pharmacological therapy for this functional disorder. Mindfulness-based stress reduction (MBSR), a meditation-based intervention developed by Kabat-Zinn at the University of Massachusetts, has been increasingly shown to be effective for many patients with a variety of functional disorders. Recent small pilot studies suggest that MBSR may also provide an important benefit as an adjunctive therapy for patients with migraine headaches. In this application, we propose to address these knowledge gaps through a large-scale, multi- component study centered around a Phase III randomized clinical trial of MBSR for patients with moderate-to- severe migraine headache. We will first identify a large number of migraineurs in the Northern California-based Sutter Health system using analytic tools previously developed by our group. Next, using latent class analysis, we will identify subgroups of migraine patients defined by comorbidities. We will then enroll 250 patients with a pattern of 4-14 headaches per month and randomize them to a full MBSR intervention with usual care or usual care alone, with follow-up at 4, 8, and 12 months post-randomization. The primary outcome is change in headache frequency at 4 months; with several secondary outcomes measured at all time points, including assessments of pain, disability, quality of life, mood, and sleep quality. The results of this innovative study will provide valuable information for patients and clinicians seeking to improve the clinical care and patient outcomes for migraineurs.

 描述（由申请人提供）：偏头痛是美国最常见的神经系统疾病之一，是全球20大致残原因之一。偏头痛目前是15-44岁女性疾病负担的主要原因之一，估计影响全球11%的成年人口，其中女性占很大比例。目前的治疗方法主要是基于药物的，但往往受到有效性不足，许多偏头痛特异性药物的高成本和常见副作用的限制。此外，可能存在偏头痛的亚型，其可能影响对治疗的反应的可能性，但迄今为止这些亚型的研究很少。此外，许多患者有兴趣探索这种功能性疾病的药物治疗的替代方案。正念减压（MBSR）是由马萨诸塞州大学的卡巴津（Kabat-Zinn）开发的一种基于冥想的干预方法，越来越多的研究表明，它对许多患有各种功能障碍的患者有效。最近的小型试点研究表明，正念减压疗法也可能为偏头痛患者提供一种重要的治疗益处。在本申请中，我们提出通过一项大规模、多组分研究来解决这些知识缺口，该研究以MBSR治疗中度至重度偏头痛患者的III期随机临床试验为中心。我们将首先确定大量的偏头痛患者在北方加利福尼亚州的萨特卫生系统使用分析工具，以前开发的我们的团队。接下来，使用潜在类别分析，我们将确定由合并症定义的偏头痛患者亚组。然后，我们将招募250名每月头痛4-14次的患者，并将他们随机分配到常规护理或仅常规护理的全面MBSR干预中，并在随机分配后4个月，8个月和12个月进行随访。主要结局是4个月时头痛频率的变化;在所有时间点测量几个次要结局，包括疼痛，残疾，生活质量，情绪和睡眠质量的评估。这项创新研究的结果将为寻求改善偏头痛患者临床护理和患者预后的患者和临床医生提供有价值的信息。