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Study for Childhood Headaches: CBT with or without Amitriptyline

This study is looking for young people aged 10 to 17 who experience frequent headaches, including migraines. It compares two ways to help reduce headaches: Cognitive Behavioral Therapy (CBT) given through telehealth, either alone or combined with a daily pill called amitriptyline. The study wants to see which approach is more effective at reducing headache days and improving how headaches affect daily life. To join, you need to have a diagnosis of migraine or continuous headaches with migraine-like episodes, and experience headaches at least four times a month. The study is currently unclear on its recruitment status and plans to enroll 400 participants.

Study design
This is an interventional study comparing two treatment approaches for childhood headaches. It plans to enroll 400 participants.
What's involved
You would be involved in the study for about 28 weeks, including a 4-week baseline period, followed by 8 weeks of six telehealth CBT sessions. Some participants will also take daily amitriptyline during this time, with dose adjustments.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes in headache days and a score called PedMIDAS up to 20-24 weeks after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05889624

Responding With Evidence and Access for Childhood Headaches

Recruiting
NAAges 10–17InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~400 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:CBTAmitriptyline

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in number of headache days
Measured over baseline to weeks 4-8 to weeks 20-24 (post treatment)
+1 more outcome measured

Conditions

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

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Migraine

Where it's being run

15 sites across 14 states
Ohio2
Alabama1
Arizona1
California1
Colorado1
Delaware1
Georgia1
Kentucky1

Study leadership

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

Who to contact

LeighAnn Chamberlin, MEd
[email protected]
513-636-9739
Email the study team

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Eligibility criteria

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 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

What this trial measures

  • Change in number of headache daysbaseline to weeks 4-8 to weeks 20-24 (post treatment)

    This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.

  • Reduction to a PedMIDAS score of 20 or lessbaseline to weeks 20-24 (post treatment)

    The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant.