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

增强共病失眠儿童偏头痛自我管理的功效

• 批准号: 10382294
• 负责人: Emily F Law
• 金额: $ 61.1万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-14 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10382294
• 关键词: Address; Adolescence; Adolescent; Adult; Aftercare; Age; Anxiety; Arousal; Arthritis; Auras; Beds; Behavioral; Caffeine; Child; Childhood; Chronic; Cognitive; Cognitive Therapy; Comorbid Insomnia; Data; Education; Emotional; Frequencies; Future; Goals; Headache; Health; Health Care Costs; Health Services; Healthcare; High Prevalence; Hygiene; Individual; Internet; Intervention; Knowledge; Lead; Maintenance; Malignant Neoplasms; Mediating; Mediator of activation protein; Mental Depression; Methods; Migraine; Monitor; Napping; Online Systems; Outcome; Pain; Pain Research; Pain intensity; Pain management; Parents; Patient Self-Report; Pattern; Periodicity; Persons; Phase; Population; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Risk; Risk Factors; Self Management; Severities; Sleep; Sleep Deprivation; Sleep Disorders; Sleep disturbances; Sleeplessness; Symptoms; Testing; Time; Visit; Youth; actigraphy; anxiety symptoms; barrier to care; chronic pain; clinical practice; cohort; comorbidity; cost; depressive symptoms; diaries; digital health; disability; efficacy testing; experience; follow-up; health related quality of life; improved; innovation; migraine treatment; novel; pain outcome; phase II trial; poor sleep; post intervention; primary outcome; programs; psychologic; response; secondary outcome; sleep behavior; sleep health; sleep pattern; sleep physiology; sleep quality; treatment comparison; trial comparing; trial design

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.

项目摘要 偏头痛是一种主要的儿科健康问题，影响10-12%的青少年。睡眠不好是一种常见的并发症， 特别是失眠症状，65-71%的青少年偏头痛患者报告了失眠症状。失眠 有助于更大的头痛相关的残疾，更频繁的头痛，更高的疼痛强度，更大的 焦虑和抑郁症状，生活质量下降，医疗保健使用增加。童年历史 偏头痛使年轻人面临终身偏头痛和残疾的风险， 成年因此，找到有效的方法，支持青年在偏头痛的自我管理是一个优先事项。 疼痛的认知行为疗法（CBT）是偏头痛青年的既定治疗方法; 然而，睡眠的改善是不一致的。事实上，我们的初步数据表明， 是年轻人在CBT疼痛治疗中疼痛结局改善较少的风险因素。睡眠与偏头痛 共享一个周期性的关系，数据表明失眠症状会增加成人偏头痛的严重程度 和儿童CBT治疗失眠已被证明对改善患有失眠症的成年人的失眠症状有效。 然而，偏头痛和其它疼痛病症对疼痛的影响是不一致的。事后分析 这表明，只有在睡眠持续改善后，疼痛才会发生变化，但这 从来没有经过实证检验。在拟议的研究中，我们将通过使用 创新2期试验设计：1）测试CBT失眠干预对偏头痛青年的疗效， 共病失眠，2）研究睡眠的变化如何改变对CBT疼痛干预的反应。 我们将研究一组180名年龄在11-17岁的青少年偏头痛患者（有或无先兆，慢性偏头痛） 和共病失眠症在第一阶段，青少年将被随机分配接受互联网提供的CBT 失眠干预或互联网睡眠教育控制超过4周。在第二阶段，所有青年都将获得 通过互联网提供的CBT疼痛干预超过8周。评估将在基线时进行， 1期干预，2期干预后立即进行，并在干预后6个月重复进行。的 阶段1的主要结果是失眠症状。第2阶段的主要结局是头痛相关 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。睡眠卫生和睡前觉醒将被评估为 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、动态活动监测和14天日记。考虑到高 青少年偏头痛患者失眠的患病率，CBT失眠干预对该人群的扩展 将解决临床实践中的一个重要差距，并在概念上理解之间的关系， 睡眠和偏头痛。通过测试单独的CBT失眠干预，我们将能够将这种治疗应用于 其他儿科人群的未来（例如，癌症、关节炎），他们通常患有失眠症。