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

Completed · Not applicable

Conditions studied: Insomnia, Migraine Disorders, Headache Disorders

In brief

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.

Key facts

Study ID

NCT04936321

Run by

Seattle Children's Hospital

People needed

224

Starts

2021-10-01

Expected to finish

2026-05-06

Last updated by the study team

2026-07-29

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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