Internet-Delivered CBT for Migraine

(I-SPY-RCT Trial)

Overseen By Emily Law, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Non-English, Sleep disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

224 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Emily Law, PhD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

This trial is for adolescents aged 11-17 who have had headaches for at least three months and insomnia symptoms in the past month. They must be able to use the internet, speak English, read at a 5th grade level or higher, and complete surveys on their own. Those with diagnosed sleep disorders like apnea or narcolepsy, serious conditions such as diabetes or cancer can't participate.

Inclusion Criteria

Access to the Internet on any web-enabled device

I am between 11 and 17 years old.

I have had headaches for 3+ months and trouble sleeping for the last month.

Exclusion Criteria

I have been diagnosed with a sleep disorder.

Unable to read at 5th grade level or complete surveys independently

I have a serious long-term health condition like diabetes or arthritis.

Treatment Details

Interventions

• Internet-delivered CBT for Insomnia
• Internet-delivered CBT for Pain Management
• Internet-delivered Sleep Education

Trial Overview The trial tests if online cognitive-behavioral therapy (CBT) can help teens with migraines sleep better and reduce headache pain. It compares CBT for insomnia alone against combined CBT for both insomnia and pain management versus just learning about good sleep habits online.

Participant Groups

Group I: CBT for Insomnia + CBT for Pain Experimental Treatment 2 Interventions

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.

Group II: Sleep Education + CBT for Pain Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+