RECRUITING

Responding With Evidence and Access for Childhood Headaches

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Conditions

HeadacheHeadache DisordersHeadache, MigraineMigraineMigraine DisordersMigraine With AuraMigraine Without AuraChronic Migrainecognitive behavioral therapypediatricsdiaphragmatic breathingprogressive muscle relaxationimageryrelaxationbiofeedback

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-08-22
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05889624

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.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization
  3. * Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine
  4. * English fluency: Able to complete the study visits and questionnaires in English
  1. * Current treatment includes amitriptyline and/or CBT specific to headache care
  2. * Current prescribed preventive antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the baseline phase
  3. * Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention
  4. * Youth who are pregnant
  5. * 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
  6. * 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

Contacts and Locations

Study Contact

LeighAnn Chamberlin, MEd
CONTACT
513-636-9739
leighann.chamberlin@cchmc.org
Megan Pfeiffer
CONTACT
513-636-1846
megan.pfeiffer@cchmc.org

Principal Investigator

Scott Powers, PhD
PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Medical Center, Cincinnati

Study Locations (Sites)

University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, 85016-7710
United States
University of California San Francisco
San Francisco, California, 94115
United States
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Nemours Children's Health System
Wilmington, Delaware, 19810
United States
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, 30328
United States
University of Louisville Health/Norton
Louisville, Kentucky, 40292
United States
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, 70118-5720
United States
Dent Neurological Institute
Amherst, New York, 14226
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Childrens
Columbus, Ohio, 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, 38103
United States
Marshall Health
Huntington, West Virginia, 25701
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-22
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-08-22
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • headache
  • migraine
  • cognitive behavioral therapy
  • pediatrics
  • diaphragmatic breathing
  • progressive muscle relaxation
  • imagery
  • relaxation
  • biofeedback

Additional Relevant MeSH Terms

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