Responding With Evidence and Access for Childhood Headaches

Description

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.

Conditions

Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura, Chronic Migraine

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Study Overview

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Study Details

Study overview

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.

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

Responding With Evidence and Access for Childhood Headaches

Condition
Headache
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Children's of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital - Barrow Neurological Institute, Phoenix, Arizona, United States, 85016-7710

San Francisco

University of California San Francisco, San Francisco, California, United States, 94115

Aurora

University of Colorado/Children's Hospital Colorado, Aurora, Colorado, United States, 80045

Wilmington

Nemours Children's Health System, Wilmington, Delaware, United States, 19810

Atlanta

Clinical Integrative Research Center of Atlanta, Inc, Atlanta, Georgia, United States, 30328

Louisville

University of Louisville Health/Norton, Louisville, Kentucky, United States, 40292

New Orleans

Louisiana State Univ/Children's Hospital of New Orleans, New Orleans, Louisiana, United States, 70118-5720

Amherst

Dent Neurological Institute, Amherst, New York, United States, 14226

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

10 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Scott Powers, PhD, PRINCIPAL_INVESTIGATOR, Cincinnati Childrens Medical Center, Cincinnati

Study Record Dates

2027-12-31