An interventional study of Internet-delivered CBT for Insomnia and Internet-delivered CBT for Pain Management in Insomnia, Migraine Disorders and Headache Disorders, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 224 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
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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.
Behavioral: Internet-delivered CBT for Pain Management · Behavioral: Internet-delivered Sleep Education
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.
Behavioral: Internet-delivered CBT for Insomnia · Behavioral: Internet-delivered CBT for Pain Management
The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.
The program delivers the core components of CBT for pain management including: pain education, training in behavioral and cognitive pain coping skills, instruction in increasing activity participation, and training in parental operant and communication strategies. Treatment duration is 6 weeks.
Also known as: Web-MAP (Web-based Management of Adolescent Pain)
The program delivers publicly available information about sleep.
Change in insomnia symptoms
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.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in headache-related disability
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
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in sleep quality
The Adolescent Sleep Wake Scale-Short Form (ASWS) is a 10-item measure. The total score indicates overall perception of sleep quality.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in sleep patterns
14-days of actigraphic monitoring with the Actiwatch Spectrum Plus to assess minutes of estimated sleep, wake time after sleep onset, and sleep efficiency.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in headache frequency
The number of headache days reported each day for 14 days.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in headache pain intensity
11-point numerical rating scale with anchors of 0 = no pain to 10 = worst pain possible. Reported each day for 14 days.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in anxiety symptoms
The Generalized Anxiety Disorder-7 is a 7-item measure. The total score indicates anxiety severity over the last two weeks.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Change in depressive symptoms
The Patient Health Questionnaire-9 is a 9 item measure. The total score indicates severity of depression over the last two weeks.
Time frame: 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
The Pediatric Quality of Life Inventory 4.0. is a measure of health-related quality of life. The total score indicates perceived mental and physical health.
Time frame: Baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up
Plan to share: No
Ran from Oct 2021 to primary completion in Mar 2026, 53 months.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 53 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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