Mindfulness and Migraine: A Randomized Controlled Trial

 描述(申请人提供)：偏头痛是美国最常见的神经疾病之一，是全球前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，其中女性占主导地位。目前的治疗方法主要是以药物为基础的，但往往受到有效性不足、许多偏头痛特效药的高昂成本和常见副作用的限制。此外，可能存在影响治疗反应可能性的偏头痛亚型，但到目前为止，对这些亚型的研究很少。此外，许多患者对探索这种功能性疾病的药物治疗的替代方案感兴趣。基于正念的压力减轻(MBSR)是马萨诸塞大学的Kabat-Zinn开发的一种基于冥想的干预措施，越来越多地被证明对许多患有各种功能障碍的患者有效。最近的小规模试点研究表明，MBSR作为偏头痛患者的辅助治疗也可能提供重要的好处。在这项应用中，我们建议通过一项以MBSR针对中到重度偏头痛患者的MBSR第三阶段随机临床试验为中心的大规模多成分研究来解决这些知识差距。我们将首先使用我们小组以前开发的分析工具，在北加州的Sutter Health System中识别大量偏头痛患者。下一步，我们将使用潜在分类分析，确定由并存疾病定义的偏头痛患者的亚组。然后，我们将招募250名每月头痛4-14例的患者，并将他们随机分配到全面的MBSR干预组，接受常规护理或单独常规护理，并在随机化后4、8和12个月进行随访。主要结果是4个月后头痛频率的变化；在所有时间点测量几个次要结果，包括对疼痛、残疾、生活质量、情绪和睡眠质量的评估。这项创新性研究的结果将为寻求改善偏头痛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。

 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.