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

在线团队偏头痛：旨在管理偏头痛的在线技术和教育

• 批准号: 10656355
• 负责人: Rebecca Erwin Wells
• 金额: $ 64.12万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10656355
• 关键词: Acute; Address; Adult; Affect; Age; American; Analgesic Overuse Headaches; Anxiety; Area; Attention; Awareness; Bed rest; Behavior Therapy; Biometry; Brain; Clinical; Clinical Trials; Consolidated Framework for Implementation Research; Data; Disease; Dose; Education; Electronics; Evaluation; Feeling; Frequencies; Funding; Future; Goals; Headache; Health; Home; Internal Medicine; Internet; Interoception; Intervention; Mediating; Meditation; Mental Depression; Mental Health; Methodology; Migraine; Mind-Body Intervention; Monitor; National Center for Complementary and Integrative Health; Nociception; Opioid; Pain; Participant; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Phase; Population Heterogeneity; Public Health; Publishing; Recommendation; Reporting; Research; Research Personnel; Risk; Safety; Sampling; Self Efficacy; Standardization; Stress; Techniques; Technology; Tension Headache; Thinking; Time; addiction; behavioral clinical trial; bodily sensation; career; chronic pain; clinically significant; cognitive function; comparison group; cost; design; disability; disability impact; eHealth; efficacy evaluation; efficacy testing; emotion regulation; evidence base; experience; flexibility; follow-up; future implementation; health disparity; health equity; implementation intervention; implementation science; implementation study; implementation trial; improved; instructor; interest; migraine treatment; mindfulness; mindfulness intervention; mindfulness-based stress reduction; nervous system disorder; non-drug; non-opioid analgesic; online intervention; opioid use; pain catastrophizing; pandemic disease; perceived stress; post intervention; primary endpoint; primary outcome; programs; randomized, clinical trials; recruit; remote assessment; remote delivery; response; secondary outcome; side effect; targeted treatment; telehealth

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.

概括 偏头痛是世界上的残疾第二大主要原因。在偏头痛的4500万美国人中，有一半需要 卧床救济。偏头痛会影响整体健康，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获了疾病对患者生活的全部影响。偏头痛药物是 受副作用，缺乏疗效和成本的限制。尽管建议使用阿片类药物使用的风险 药物过度使用头痛和成瘾，三分之一的美国人患有偏头痛的美国人转向阿片类药物，以急性缓解。 对具有长期疗效的靶向残疾的更有效偏头痛疗法的需求未满足， 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， 顶部偏头痛触发器。正念可能通过与大脑机制改变疼痛经历 伤害性处理，认知功能和情绪调节。我们已经表现出正念 对残疾，疼痛灾难性，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提高。我们的 先前的研究利用具有高方法论严格的设计（例如，RCT），但规模适中 能够与有限的可推广性的亲自类别的参与者的同质样本。这样的 灵活的在线选项可以抵消限制。偏头痛患者对电子（E）健康感兴趣 选项但很少有基于证据的选项。该提案通过使用大量研究来解决这些差距 全国招聘和在线，可访问的干预措施，旨在提供关键的正念 不同人口的原则。我们计划测试在线MBSR与在线HA成人教育的功效 在3阶段RCT中使用偏头痛。主要目标是评估功效（AIM 1），其次要目标的 了解机制（目标2）并收集数据（目标3），以进行未来的可扩展实施研究。作为 以前完成的是，干预措施将与时间/关注相匹配，参与者将继续所有当前 偏头痛药物，正如我们所表明的药物和行为治疗的影响最大。这 完全远程交付的研究将确定在线MBSR在偏头痛成年人中的功效 迫切需要在偏头痛残疾的以患者为中心的结果上更好地偏头痛治疗。我们是 使用eHealth交付格式，与In-相比 人每周课。可以利用心理治疗来提高健康公平，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审判，以最终 具有不同背景的偏头痛的患者将具有易于访问，标准化，非药物，非 - 非 - 阿片类药物治疗可用于全世界针对偏头痛及其高度普遍的疾病 相关的残疾。