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โ† Trials
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Responding With Evidence and Access for Childhood Headaches

RecruitingNAAges 10 Years - 17 YearsAllChildren's Hospital Medical Center, Cincinnati
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • CBT
  • Amitriptyline
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Where

15 sites
University of Alabama at Birmingham Children's of Alabama
Birmingham, United States
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, United States
University of California San Francisco
San Francisco, United States
University of Colorado/Children's Hospital Colorado
Aurora, United States
Nemours Children's Health System
Wilmington, United States
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, United States
Norton Children's Neuroscience Institute/ UofL School of Medicine
Louisville, United States
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, United States

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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