Responding With Evidence and Access for Childhood Headaches
Recruiting
N/AInterventional Study
HeadacheHeadache DisordersHeadache, MigraineMigraineMigraine DisordersMigraine With AuraMigraine Without AuraChronic Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for
This trial is looking for young people who suffer from migraines. Participants will receive Cognitive Behavioral Therapy (CBT) through telehealth, either alone or with a prescribed medication called amitriptyline.
Are You a Good Fit for This Trial?
Must be takingAmitriptyline
You may be able to join if
I have been diagnosed with migraines with or without aura.
I have 4 or more headache days in the last 28 days.
I am eligible for a prescription of amitriptyline.
I can complete study visits and questionnaires in English.
You may not be able to join if
I am currently being treated with amitriptyline or CBT for headaches.
I have taken preventive medication for migraines within the last few weeks.
I am currently receiving Botox or certain migraine prevention medications.
I am pregnant.
I have ongoing suicidal thoughts or a recent suicide attempt.
I have a history of bipolar disorder or prolonged QT syndrome.
I have significant constipation or gastroparesis.
I have any other condition that the study doctor believes would make me unsuitable for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 t…
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.
Trial Locations
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Eligibility Criteria
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 presentat…
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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