Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Change in insomnia symptoms
研究概览
简要总结
Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.
详细描述
This aims of this study are to: 1) test efficacy of cognitive-behavioral therapy (CBT) insomnia intervention for youth with migraine and comorbid insomnia, and 2) investigate how changes in sleep may modify response to CBT pain intervention. Participants will include 250 youth and their parents. Youth will be ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In Phase 1, participants will be randomly assigned to receive access to internet-delivered CBT insomnia intervention or internet-delivered sleep education control over 6 weeks. In Phase 2, all participants will receive access to internet-delivered CBT pain intervention over 6 weeks. Assessments will occur at baseline, immediately after Phase 1 intervention, immediately after Phase 2 intervention, and 6 month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Because all study procedures delivered online, neither study participants nor investigators. care providers, or outcomes assessors will have knowledge of the treatment assignment and thus this trial can be carried out as a double-blinded RCT.
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-17 years old
- •Headache present for at least three months and insomnia symptoms for the past month
- •Access to the Internet on any web-enabled device
排除标准
- •Non-English speaking
- •Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy)
- •Unable to read at 5th grade level or complete surveys independently
- •A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)
研究组 & 干预措施
Sleep Education + CBT for Pain
Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.
干预措施: Internet-delivered CBT for Pain Management (Behavioral)
Sleep Education + CBT for Pain
Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.
干预措施: Internet-delivered Sleep Education (Behavioral)
CBT for Insomnia + CBT for Pain
Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.
干预措施: Internet-delivered CBT for Insomnia (Behavioral)
CBT for Insomnia + CBT for Pain
Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.
干预措施: Internet-delivered CBT for Pain Management (Behavioral)
结局指标
主要结局
Change in insomnia symptoms
时间窗: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
The 7-item Insomnia Severity Index (ISI) measures severity of insomnia symptoms. Total scores above 8 on the ISI indicate clinically significant insomnia in adult and adolescent samples.
Change in headache-related disability
时间窗: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
The CALI-9 is a 9-item self-report instrument of headache-related disability in children and adolescents that measures difficulty in performing usual daily physical, social, and recreational activities. The measure will be completed daily for 14 days at baseline, after phase 1, after phase 2, and 6-month follow-up
次要结局
- Change in sleep quality(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in anxiety symptoms(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in depressive symptoms(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in sleep patterns(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in headache frequency(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in headache pain intensity(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
- Change in health-related quality of life as assessed by the Pediatric Quality of Life Inventory 4.0(Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up)
研究者
Emily Law
Associate Professor
Seattle Children's Hospital