Migraine is a neurological disease. The symptoms include moderate to severe head pain, a throbbing or pounding sensation, sensitivity to light and sound, greater pain upon engaging in activity, and nausea. The pain can last hours to days and is often quite disabling for people. About 7 million children with the United States have migraine (about 10% of the population). If a young person begins to experience migraine, they are quite likely to continue to live with this disease over their lifetime.

The vast majority of migraine research involves adults. Few studies have been conducted with children and adolescents. Because results from pediatric studies often do not match up with adult findings, it is really important to base treatment decisions on studies that include young patients.

There are evidence-based practice guidelines for preventive treatment of youth with migraine. They recommend a combined therapy of the drug, amitriptyline, and a nonpharmacologic intervention called cognitive behavioral therapy or CBT. CBT alone has also been shown to be helpful to youth with migraine, reducing headache days and disability. Medications have side effects; CBT has very few. So, doctors, patients, families, insurance providers, and public policy makers do not know if it is better to do a nonpharmacologic treatment alone or if patients need a combined therapy.

CBT teaches youth about how pain is experienced by the body and the brain, helps them learn relaxation skills that reduce bodily stress and pain, and works with them to reduce negative thought and feeling patterns (such as always thinking the worst is going to happen, or that a migraine is going to ruin an important event, or keep them from doing an important activity like attending school). Parents also learn how to be effective coaches to reinforce their child’s efforts at active coping. Importantly, once a person learns these skills, they can continue to use them over time; unlike a medication that they’ve stopped taking.

As a result of adjusting medical care due to the COVID-19 pandemic, psychologists who provide CBT to youth with migraine have needed to deliver care via telehealth (i.e., virtually rather than in-person). They have found this treatment to be as effective by telehealth as when it was delivered face-to-face, and patients and families have really liked it. Because of the huge need to make CBT more accessible, in this project CBT sessions will be delivered via telehealth. This will be one of the first clinical trials to do this and the results could have a big impact on how care is delivered in the future.

The goal of this study is to compare combined therapy (CBT and amitriptyline) to CBT alone. The aim is to see if there are differences between the two approaches on outcomes such as reduction in headache days, migraine-related disability (e.g., missing school, not able to do homework or chores, not able to attend social activities or participate in sports due to headaches), physical functioning, and overall quality of life. Side effects and the safety of the treatments will also be examined. Four hundred families of youth ages 10 to 17 will be asked to participate. There are 15 sites across the country who regularly care for youth with migraine and have experience collaborating on research who will be recruiting for this study. Half of the youth will be randomly selected to receive combined therapy, the other half CBT alone. CBT will be delivered via telehealth. The treatments will occur over 6 months. Outcomes will be collected at 1 month prior to starting treatment and at the 6-month mark.

For this study, there are a number of stakeholder groups who will be involved from the planning stage all the way to informing others about the study outcomes once it is completed. These groups include physicians and advance practice providers (e.g., nurse practitioners), psychologists, patients, parents, advocates and members of national organizations such as the American Headache Society and the United States Association for the Study of Pain, and insurance payors and health care financial experts. Stakeholders will use the unique information that is learned from this study to provide and pay for the best preventive care possible to youth with migraine.