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Behavioral Intervention

Internet-Delivered CBT for Migraine (I-SPY-RCT Trial)

N/A

Waitlist Available

Led By Emily Law, PhD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

11-17 years old

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Awards & highlights

I-SPY-RCT Trial Summary

This trial is testing whether CBT for insomnia can help reduce symptoms and disability related to migraines in adolescents.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this study involves non-medical interventions like online education and therapy sessions, side effects are minimal but may include discomfort from discussing personal issues during therapy.

I-SPY-RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11 and 17 years old.

I-SPY-RCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in headache-related disability

Change in insomnia symptoms

Secondary outcome measures

Change in anxiety symptoms

Change in depressive symptoms

Change in headache frequency

+4 more

I-SPY-RCT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT for Insomnia + CBT for PainExperimental Treatment2 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 PainActive Control2 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,783 Total Patients Enrolled

University of VirginiaOTHER

753 Previous Clinical Trials

1,244,807 Total Patients Enrolled

Emily Law, PhDPrincipal InvestigatorSeattle Children's Research Institute

1 Previous Clinical Trials

21 Total Patients Enrolled

Media Library

Internet-delivered CBT for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04936321 — N/A

Migraine Research Study Groups: CBT for Insomnia + CBT for Pain, Sleep Education + CBT for Pain

Migraine Clinical Trial 2023: Internet-delivered CBT for Insomnia Highlights & Side Effects. Trial Name: NCT04936321 — N/A

Internet-delivered CBT for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04936321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the elderly population being considered for inclusion in this trial?

"This study exclusively takes participants between 11 and 17 years old, in accordance with the eligibility criteria."

Answered by AI

What is the maximum capacity of participants for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is still searching for 180 volunteers from one medical centre. The study was initially posted on October 1st 2021 and has been recently updated on June 9th 2022."

Answered by AI

May I be enrolled in this experiment?

"For this research, 180 minors aged 11-17 who have suffered from headaches for the past three months and insomnia in the last month are being sought. Candidates must also possess access to an Internet-capable device."

Answered by AI

What ultimate goal is this clinical trial attempting to accomplish?

"The primary purpose of this trial, which will be evaluated at baseline, post treatment phases 1&2 and 6-month follow up is to evaluate the alteration in symptoms associated with insomnia. Secondary objectives include assessing changes in health related quality of life as measured by Pediatric Quality of Life Inventory 4.0; ascertainment of variations in headache pain intensity via an 11 point numerical rating scale; and gauging shifts in sleep quality through Adolescent Sleep Wake Scale-Short Form (ASWS)."

Answered by AI

Are there any vacancies available to participate in this clinical experiment?

"Affirmative. According to the details hosted on clinicaltrials.gov, this medical research is presently recruiting participants who meet its criteria. The study was first advertised in October 2021 and revised most recently in June 2022; it has 180 slots available at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Emily Law 2021. "Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04936321.

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