NCT04936321

Intervention for Sleep and Pain in Youth: a Randomized Controlled Trial

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Insomnia
• Migraine Disorders
• Headache Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Internet-delivered CBT for Insomnia	The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.
BEHAVIORAL	Internet-delivered CBT for Pain Management	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.
BEHAVIORAL	Internet-delivered Sleep Education	The program delivers publicly available information about sleep.

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-06-23
• Last updated: 2024-12-17

Locations

1 site across 1 country: United States