Project Summary

PCORI has identified preventing migraine as an important research topic. Many medicines can help reduce how often migraine headaches occur, how severe they are, and how long they last. But few studies have compared standard treatments to new ones. Non-medicine treatments also may help prevent migraine. Patients, caregivers, clinicians, and others want to learn: How do different medicine and non-medicine treatments compare for preventing migraine? To help answer this question, PCORI launched an initiative in 2021 on Pharmacologic and Nonpharmacologic Treatments for Migraine Prevention. The initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Migraine is a neurological illness that affects about 7 million youth in the United States. Symptoms of migraine may include throbbing head pain, sensitivity to light or noise, and nausea. Migraine can keep youth from going to school or doing activities like sports.

Treatments for migraine include cognitive behavioral therapy, or CBT, and medicine. CBT is a kind of talk therapy in which people learn to change patterns in their thinking to improve how they feel. CBT can be delivered in person or by telehealth. Telehealth is a way to provide care to patients remotely using phone, video, or monitoring devices that can help manage care.

In this study, the research team is comparing the use of CBT alone, delivered via telehealth, versus telehealth CBT plus medicine for preventing migraine in youth.

Who can this research help?

Results from this study may help doctors, patients, and parents when considering ways to prevent migraine in youth.

What is the research team doing?

The research team is recruiting 400 patients ages 10–17 with migraine from 15 sites across the country that provide care for youth with migraine. The team is assigning the youth by chance to receive telehealth CBT alone or with medicine.

All youth receive six CBT sessions over an 8-week period, then another three sessions over an additional 16-week period. Trained therapists lead the sessions, which last 45 minutes. During the sessions, youth learn how their body and brain experience pain. They also learn relaxation skills to help reduce stress and pain. Parents attend two sessions that teach ways to help youth use CBT skills.

Youth assigned to receive medicine in addition to CBT take amitriptyline once a day for 24 weeks.

Youth are using a diary to record their headaches each day for six months. The team is also surveying youth about how their headaches affect school, home, play, and social activities.

Youth with migraine, parents, therapists, neurologists, members of national pain and headache groups, and health insurers are helping to plan and conduct this study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 400 patients ages 10-17 with migraine
Interventions/
Comparators
  • CBT
  • CBT plus amitriptyline
Outcomes

Primary: whether a 50% reduction occurs in headache days; whether the PedMIDAS score is reduced to 20 or less (PedMIDAS measures headache disability, or the impact of headaches on school, home, play, and social activities)

Secondary: reduction in headache disability absolute score, reduction in absolute number of headache days

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 6-month follow-up for primary outcomes

Project Information

Scott Powers, PhD
Cincinnati Children's Hospital
$11,502,147
CBT via Telehealth + Amitriptyline Compared to CBT via Telehealth: Pediatric Migraine Prevention

Key Dates

July 2022
December 2028
2022

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 24, 2024