Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Amy Gelfand, MD
Headshot of Amy Gelfand
Amy Gelfand

Description

Summary

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

Official Title

Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)

Details

Migraine is the second most disabling disease in the world. Research has primarily focused on treating migraine in adults; however, approximately 10% of children and adolescents have migraine, suggesting that up to 7 million youth are impacted in the United States alone. Given that the majority of youth have migraine symptoms that persist into adulthood, there is a critical need to identify and improve access to the most effective preventive migraine treatments for this population as a means of reducing the long-term healthcare burden and functional impairment of this illness.

This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone.

Participants will be involved in the study for approximately 28 weeks, with the first 4 weeks being a baseline period and the next 8 weeks involving six telehealth CBT sessions for both study groups (CBT while taking a clinically-prescribed pill-based prevention therapy [amitriptyline] compared to CBT alone), and dose titration of clinically-prescribed medication (amitriptyline) for the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group. During the remaining 16 weeks the participants will maintain the dose of medication (in the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group) and attend "booster" CBT sessions held three times over 4 months.

Keywords

Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura, Chronic Migraine, cognitive behavioral therapy, pediatrics, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback, Amitriptyline, CBT, CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline), CBT alone

Eligibility

You can join if…

Open to people ages 10-17

  • Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)
  • Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization
  • Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine
  • English fluency: Able to complete the study visits and questionnaires in English

You CAN'T join if...

  • Current treatment includes amitriptyline and/or CBT specific to headache care
  • Current prescribed preventive antimigraine medication within a period equivalent to < 5 half-lives of that medication before entering the baseline phase
  • Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
  • Youth who are pregnant
  • Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis
  • Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant

Locations

  • UCSF not yet accepting patients
    San Francisco California 94115 United States
  • Phoenix Children's Hospital - Barrow Neurological Institute not yet accepting patients
    Phoenix Arizona 85016-7710 United States
  • University of Alabama at Birmingham Children's of Alabama accepting new patients
    Birmingham Alabama 35233 United States
  • Cincinnati Children's Hospital Medical Center accepting new patients
    Cincinnati Ohio 45229 United States

Lead Scientist at UCSF

  • Amy Gelfand, MD
    Dr. Amy Gelfand is a board-certified child neurologist and Director of Pediatric Headache at UCSF. She specializes in diagnosing and treating children who suffer from a variety of headache disorders, as well as children with childhood periodic syndromes such as abdominal migraine that may be precursors to migraine headache later in life.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati
ID
NCT05889624
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated