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: 10442033
• 负责人: Rebecca Erwin Wells
• 金额: $ 67.72万
• 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/10442033
• 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; Esthesia; Evaluation; Feeling; Frequencies; Funding; Future; Goals; Headache; Health; Home; Intercept; 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; Randomized Clinical Trials; Recommendation; Reporting; Research; Research Personnel; Risk; Safety; Sampling; Self Efficacy; Standardization; Stress; Techniques; Technology; Tension Headache; Thinking; Time; addiction; base; behavioral clinical trial; 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; recruit; remote assessment; remote delivery; response; secondary outcome; side effect; targeted treatment; technology validation; 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 偏头痛是世界上第二大致残原因； 4500 万患有偏头痛的美国人中有一半需要 卧床休息以缓解压力。偏头痛影响整体健康、人际关系、职业和财务稳定性。残疾是一种 以患者为中心的结果，捕捉疾病对患者生活的全面影响。偏头痛药物有 受到副作用、缺乏疗效和成本的限制。尽管由于风险而建议不要使用阿片类药物 药物过度使用引起头痛和成瘾，三分之一的美国人患有偏头痛，转而使用阿片类药物来紧急缓解。 对于更有效的偏头痛疗法的需求尚未得到满足，这些疗法针对残疾且具有长期疗效， 安全性和耐受性。基于正念的减压 (MBSR) 可以帮助缓解偏头痛，因为它针对的是压力、 顶级偏头痛触发因素。正念可能通过与以下相关的大脑机制改变疼痛体验 伤害感受处理、认知功能和情绪调节。我们已经证明正念已经 对残疾、疼痛灾难性、抑郁症和抑郁症具有统计显着性和临床意义的益处 偏头痛患者的自我效能感。拦截意识和头痛频率也有所改善。我们的 先前的研究采用了方法论严谨的设计（例如 RCT），但规模不大 能够参与面对面课程的参与者的同质样本限制了普遍性。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)Health 感兴趣 选项，但很少有基于证据的选项存在。该提案通过一项大型研究解决了这些差距 全国招募和在线、可访问的干预措施，旨在提供关键的正念 针对不同人群的原则。我们计划测试成人在线 MBSR 与在线 HA 教育的效果 3 期随机对照试验中患有偏头痛。主要目标是疗效评估（目标 1），次要目标是 理解机制（目标 2）并收集数据（目标 3）以进行未来可扩展的实施研究。作为 之前完成的干预措施将按时间/注意力进行匹配，参与者将继续所有当前的 偏头痛药物，正如我们所证明的，药物加行为治疗的效果最大。这 完全远程交付的研究将确定在线 MBSR 对成人偏头痛患者的疗效，以针对偏头痛患者 迫切需要更好的偏头痛治疗，以患者为中心的偏头痛残疾结果。我们是 与内部相比，使用电子卫生保健交付格式可以增加不同人群的获取和可用性 人每周上课。可以利用身心治疗来促进健康公平，我们将这样做 通过多种策略。如果有效，这项研究将导致实施试验，以便最终， 不同背景的偏头痛患者将获得易于获得的、标准化的、非药物的、非 阿片类药物治疗可在全球范围内用于治疗高度流行的偏头痛及其相关疾病 相关的残疾。