Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

Responding With Evidence and Access for Childhood Headaches

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

CBT

During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.

DRUG

Amitriptyline

During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).

Locations (15)

University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Health System
Wilmington, Delaware, United States
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States
University of Louisville Health/Norton
Louisville, Kentucky, United States
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Dent Neurological Institute
Amherst, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Childrens
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, United States
Dell Children's Hospital-UT Health
Austin, Texas, United States
Marshall Health
Huntington, West Virginia, United States