Online TEAM Migraine: Online Techniques and Education Aimed to Manage Migraine

摘要 偏头痛是世界上第二大致残原因；4500万美国偏头痛患者中有一半需要 卧床休息以缓解压力。偏头痛影响整体健康、人际关系、职业生涯和财务稳定。残疾是一种 以患者为中心的结果，反映了疾病对患者生活的全面影响。偏头痛的药物是 受限于副作用、缺乏疗效和成本。尽管由于存在以下风险，建议不要使用阿片类药物 药物过度使用头痛和成瘾，三分之一的美国偏头痛患者转向阿片类药物来缓解急性症状。 存在对更有效的、具有长期疗效的针对残疾的偏头痛疗法的需求尚未得到满足， 安全性和耐受性。基于正念的压力减轻(MBSR)可以帮助偏头痛，因为它针对压力， 偏头痛的最大诱因。正念可能通过与以下相关的大脑机制改变疼痛体验 伤害性加工、认知功能和情绪调节。我们已经证明了正念有 在残疾、疼痛灾害性、抑郁症和 偏头痛患者的自我效能感。截取意识和头痛频率也有所改善。我们的 以前的研究使用了具有高度方法学严谨性的设计(例如，RCT)，但规模适中 能够参与面授课程的参与者样本相同，这限制了推广能力。是这样的 灵活的在线选择可能会抵消这些限制。偏头痛患者对电子(E)健康感兴趣 选择，但基于证据的选择寥寥无几。这项建议通过一项大型研究解决了这些差距，该研究使用 国家招募和在线、可访问的干预措施，旨在提供关键的正念 原则适用于不同的人群。我们计划在成人中测试在线MBSR和在线HA教育的效果 偏头痛处于3期随机对照试验。主要目标将是评价疗效(目标1)，次要目标是 了解机制(目标2)和收集数据(目标3)，以便将来进行可扩展的实施研究。AS 之前做过的，干预将在时间/注意力上匹配，参与者将继续所有当前 偏头痛药物，正如我们已经证明的那样，药物加行为治疗的影响最大。这 完全远程传递的研究将确定在线MBSR在成人偏头痛患者中的有效性，以针对 迫切需要更好的偏头痛治疗方法，以患者为中心的偏头痛残疾结局。我们是 使用eHealth交付格式，与在以下环境中相比，可提高对不同人群的访问和可用性 每周一次的个人课程。心身治疗可以被用来促进健康公平，我们将这样做 通过各种策略。如果有效，这项研究将导致实施试验，从而最终， 不同背景的偏头痛患者将拥有易于获得的、标准化的、非药物的、非 可在全球范围内用于针对偏头痛及其高发疾病的阿片类药物治疗 相关的残疾。

Summary Migraine is the world's second leading cause of disability; half of the 45 million Americans with migraine require bedrest for relief. Migraine affects overall health, relationships, careers, and financial stability. Disability is a patient-centered outcome that captures the full impact of disease on patients' lives. Migraine medications are limited by side effects, lack of efficacy, and costs. Despite recommendations against opioid use due to risks of medication overuse headache and addiction, a third of Americans with migraine turn to opioids for acute relief. There is an unmet need for more effective migraine therapies that target disability with long-term efficacy, safety, and tolerability. Mindfulness-based stress reduction (MBSR) can help migraine as it targets stress, the top migraine trigger. Mindfulness may change the pain experience through brain mechanisms associated with nociceptive processing, cognitive function, and emotional regulation. We have shown mindfulness has statistically significant and clinically meaningful benefits on disability, pain catastrophizing, depression, and self-efficacy in patients with migraine. Interceptive awareness and headache frequency also improved. Our prior research utilized designs with high methodological rigor (e.g., RCT) but were modest in size with homogenous samples of participants able to engage with in-person classes that limited generalizability. Such limitations may be offset by flexible online options. Patients with migraine are interested in electronic (e)Health options, yet few evidenced-based options exist. This proposal addresses these gaps with a large study using national recruitment and an online, accessible intervention that was developed to deliver key mindfulness principles to diverse populations. We plan to test the efficacy of online MBSR vs. online HA education in adults with migraine in a phase 3 RCT. The main goal will be evaluation of efficacy (Aim 1), with secondary goals of understanding mechanisms (Aim 2) and gathering data (Aim 3) for a future, scalable implementation study. As done previously, interventions will be matched on time/attention and participants will continue all current migraine medications, as we have shown medication plus behavioral treatments have the greatest impact. This fully remotely delivered study will determine the efficacy of online MBSR in adults with migraine to target the urgent need for better migraine treatments on the patient-centered outcome of migraine disability. We are using an eHealth delivery format that increases access and availability to diverse populations compared to in- person weekly classes. Mind-body treatments can be leveraged to advance health equity and we will do so through a variety of strategies. If effective, this research will lead to an implementation trial so that ultimately, patients with migraine of diverse backgrounds will have an easily accessible, standardized, non-drug, non- opioid treatment that could be used worldwide to target the highly prevalent disease of migraine and its associated disability.