Testing Therapy by Video With or Without Amitriptyline for Children With Migraine
Tests video-delivered behavioral therapy with or without amitriptyline in youth with migraine.
Plain-language title generated from the registry record
Registry title: Responding With Evidence and Access for Childhood Headaches
Key facts
- Where
- Amherst, Atlanta, Aurora, Austin, Birmingham, Cincinnati, Columbus, Huntington, Louisville, Memphis, New Orleans, Philadelphia, Phoenix, San Francisco, and Wilmington, United StatesSee the 15 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT05889624, who can take part
Where in United States
- Dent Neurological InstituteAmherst, United StatesTaking people
- Clinical Integrative Research Center of Atlanta, IncAtlanta, United StatesTaking people
- University of Colorado/Children's Hospital ColoradoAurora, United StatesTaking people
- Dell Children's Hospital-UT HealthAustin, United StatesTaking people
- University of Alabama at Birmingham, Children's of AlabamaBirmingham, United StatesTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Nationwide ChildrensColumbus, United StatesTaking people
- Marshall HealthHuntington, United StatesTaking people
- Norton Children's Neuroscience Institute/ UofL School of MedicineLouisville, United StatesTaking people
- University of Tennessee Health Science Center/ LeBonheur Children's HospitalMemphis, United StatesTaking people
- Louisiana State Univ/Children's Hospital of New OrleansNew Orleans, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
- Phoenix Children's Hospital - Barrow Neurological InstitutePhoenix, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Nemours Children's Health SystemWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT05889624
- Record updated
- 21 September 2026
- Original 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.Read full original descriptionShow less
Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)
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.
Inclusion: 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: 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; 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; 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; Current treatment includes amitriptyline and/or CBT specific to headache care; Youth who are pregnant.