Enhancing Efficacy of Migraine Self-Management in Children with Comorbid Insomnia

项目总结摘要 偏头痛是影响10%-12%年轻人的主要儿科健康问题。睡眠不佳是一种常见的共病， 尤其是失眠症状，65%-71%的青少年偏头痛患者报告了失眠症状。失眠 与头痛相关的残疾程度越高，头痛越频繁，疼痛强度越大， 焦虑和抑郁症状，较差的生活质量，以及更多的卫生保健使用。儿童史 偏头痛使年轻人面临终身偏头痛和残疾的风险，以及高昂的医疗费用 成人期。因此，找到有效的方法支持青年进行偏头痛的自我管理是当务之急。 认知行为疗法(CBT)治疗疼痛是青少年偏头痛的既定治疗方法； 然而，睡眠的改善并不一致。事实上，我们的初步数据表明，糟糕的基线睡眠 对于接受CBT治疗疼痛的年轻人来说，这是一个风险因素，因为他们的疼痛结果改善较少。睡眠与偏头痛 数据表明，失眠症状会增加成年人偏头痛的严重程度 还有孩子。CBT治疗失眠已证明对改善成人失眠症状有效 然而，偏头痛和其他疼痛状况对疼痛的影响一直不一致。事后分析 表明疼痛的变化可能只有在睡眠持续改善后才会发生，但这已经 从未经过经验检验。在拟议的研究中，我们将通过使用 创新的两阶段试验设计：1)测试CBT失眠干预对青少年偏头痛和 2)研究睡眠变化如何改变对CBT疼痛干预的反应。 我们将研究一组年龄在11-17岁之间的180名患有偏头痛(有或无先兆、慢性偏头痛)的年轻人。 以及共病的失眠。在第一阶段，青少年将被随机分配接受互联网交付的CBT 失眠干预或网络睡眠教育控制4周。在第二阶段，所有青年都将获得 互联网提供的CBT疼痛干预超过8周。评估将在基线时进行，紧接着 第一阶段干预，在第二阶段干预后立即进行，并在干预后6个月重复。这个 第一阶段的主要结果是失眠症状。第二阶段的主要结果是与头痛相关的 残疾。次要结果是睡眠质量和睡眠模式、头痛频率和疼痛强度， 焦虑和抑郁症状，以及生活质量。睡眠卫生和睡前唤醒将被评估为 潜在的调解人。我们将对睡眠和头痛进行全面的多维评估 包括自我报告问卷、动态运动监测和14天的日常日记。考虑到高价 偏头痛青少年中失眠的患病率，将CBT失眠干预扩展到这一人群 将解决临床实践中的一个重要差距，以及在概念上理解 睡眠和偏头痛。通过测试一种单独的CBT失眠干预，我们将能够将这种治疗应用于 对其他儿科人群(如癌症、关节炎)来说，未来也是如此，这些人群通常会同时患上失眠。

PROJECT SUMMARY ABSTRACT Migraine is a major pediatric health problem impacting 10-12% of youth. Poor sleep is a common comorbidity, particularly insomnia symptoms, which are reported by 65-71% of adolescents with migraine. Insomnia contributes to greater headache-related disability, more frequent headache, higher pain intensity, greater anxiety and depressive symptoms, poorer quality of life, and increased health care use. History of childhood migraine places youth at risk for a lifelong pattern of migraine and disability and high health care costs in adulthood. Thus, finding effective methods that support youth in the self-management of migraine is a priority. Cognitive-behavioral therapy (CBT) for pain is an established treatment approach for youth with migraine; however improvements in sleep are inconsistent. In fact, our preliminary data suggest that poor baseline sleep is a risk factor for youth to achieve less improvement in pain outcomes with CBT for pain. Sleep and migraine share a cyclical relationship, and data indicate that insomnia symptoms increase migraine severity in adults and children. CBT for insomnia has demonstrated efficacy for improving insomnia symptoms in adults with migraine and other pain conditions, however, effects on pain have been inconsistent. Post-hoc analyses suggest that changes in pain may occur only after there are sustained improvements in sleep, but this has never been empirically tested. In the proposed study, we will address these gaps in knowledge by using an innovative 2-Phase trial design to: 1) test efficacy of CBT insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to CBT pain intervention. We will study a cohort of 180 youth, ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In Phase 1, youth will be randomly assigned to receive internet-delivered CBT insomnia intervention or internet sleep education control over 4-weeks. In Phase 2, all youth will receive internet-delivered CBT pain intervention over 8-weeks. Assessments will occur at baseline, immediately after Phase 1 intervention, immediately after Phase 2 intervention, and repeated 6 months post-intervention. The primary outcome for Phase 1 is insomnia symptoms. The primary outcome for Phase 2 is headache-related disability. Secondary outcomes are sleep quality and sleep patterns, headache frequency and pain intensity, anxiety and depressive symptoms, and quality of life. Sleep hygiene and pre-sleep arousal will be assessed as potential mediators. We will use a comprehensive multidimensional assessment of sleep and headache including self-report questionnaires, ambulatory actigraphy monitoring, and 14-day daily diaries. Given the high prevalence of insomnia in adolescents with migraine, extension of CBT insomnia intervention to this population will address an important gap in clinical practice and in conceptual understanding of the relationship between sleep and migraine. By testing a separate CBT insomnia intervention, we will be able to apply this treatment in the future to other pediatric populations (e.g., cancer, arthritis) who commonly experience comorbid insomnia.