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

总结 偏头痛是世界上第二大残疾原因; 4500万美国偏头痛患者中有一半需要治疗。 卧床休息以减轻痛苦。偏头痛影响整体健康，人际关系，职业和财务稳定。残疾是一个 以患者为中心的结果，捕捉疾病对患者生活的全面影响。偏头痛药物是 受到副作用、缺乏功效和成本的限制。尽管建议反对使用阿片类药物， 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急性缓解。 对于更有效的偏头痛疗法存在未满足的需求，所述偏头痛疗法以具有长期功效的残疾为目标， 安全性和耐受性。基于正念的减压（MBSR）可以帮助偏头痛，因为它针对的是压力， 偏头痛的最大诱因正念可能会通过与以下相关的大脑机制改变疼痛体验： 伤害性处理、认知功能和情绪调节。我们已经证明了正念 在残疾、疼痛灾难化、抑郁和 偏头痛患者的自我效能拦截意识和头痛频率也有所改善。我们 先前的研究利用具有高方法学严谨性的设计（例如，RCT），但规模适中， 参与者的同质样本能够参与限制普遍性的面对面课程。等 灵活的在线选项可以弥补这些限制。偏头痛患者对电子健康感兴趣 选择，但几乎没有基于证据的选择。本提案通过使用以下方法进行大型研究来解决这些差距 全国招募和在线，可访问的干预，开发提供关键的正念 不同人群的原则。我们计划在成人中测试在线正念减压与在线HA教育的疗效 偏头痛的第三期随机对照试验主要目标是评价疗效（目标1），次要目标是 了解机制（目标2）和收集数据（目标3），为未来的可扩展的实施研究。作为 之前完成，干预措施将在时间/注意力上匹配，参与者将继续所有当前的 偏头痛药物，正如我们所展示的药物加行为治疗具有最大的影响。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疗效， 迫切需要更好的偏头痛治疗，以患者为中心的偏头痛残疾的结果。我们 使用电子健康交付格式，与传统医疗相比， 人每周上课。身心治疗可以被用来促进健康公平，我们将这样做 通过各种各样的策略。如果有效，这项研究将导致一个实施试验，以便最终， 不同背景的偏头痛患者将有一个容易获得的，标准化的，非药物的，非 阿片类药物治疗，可用于全球范围内的目标偏头痛及其高度流行的疾病 相关残疾。

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.