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.

Public Health Relevance

Insomnia is common and highly comorbid among adolescents with migraine, impacting 65-71% of youth. The proposed project will 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. Our 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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD101471-01
Application #
9938968
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Lee, Karen
Project Start
2020-04-14
Project End
2025-03-31
Budget Start
2020-04-14
Budget End
2021-03-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Seattle Children's Hospital
Department
Type
DUNS #
048682157
City
Seattle
State
WA
Country
United States
Zip Code
98105