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Responding With Evidence and Access for Childhood Headaches

Recruiting

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

Who can join

Ages 10 to 17 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 400 · Started: Aug 22, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05889624

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Children's of Alabama, Birmingham
ArizonaPhoenix Children's Hospital - Barrow Neurological Institute, Phoenix
CaliforniaUniversity of California San Francisco, San Francisco
ColoradoUniversity of Colorado/Children's Hospital Colorado, Aurora
DelawareNemours Children's Health System, Wilmington
GeorgiaClinical Integrative Research Center of Atlanta, Inc, Atlanta
KentuckyNorton Children's Neuroscience Institute/ UofL School of Medicine, Louisville
LouisianaLouisiana State Univ/Children's Hospital of New Orleans, New Orleans
New YorkDent Neurological Institute, Amherst
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Childrens, Columbus
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
TennesseeUniversity of Tennessee Health Science Center/ LeBonheur Children's Hospital, Memphis
TexasDell Children's Hospital-UT Health, Austin
West VirginiaMarshall Health, Huntington

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.