NCT05889624Recruiting
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)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 10 May 2023
- Start date
- 22 Aug 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Migraine
- NCT number
- NCT05889624
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 22 Aug 2023 to the primary completion date, 31 Jul 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- Current treatment includes amitriptyline and/or CBT specific to headache care
- Youth who are pregnant
Who the study is looking for
- 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
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dent Neurological Institute Coordinator of this site? Confirm its status | Amherst | United States | Recruiting |
| Clinical Integrative Research Center of Atlanta, Inc Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Colorado/Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Dell Children's Hospital-UT Health Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Alabama at Birmingham, Children's of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Nationwide Childrens Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Marshall Health Coordinator of this site? Confirm its status | Huntington | United States | Recruiting |
| Norton Children's Neuroscience Institute/ UofL School of Medicine Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| University of Tennessee Health Science Center/ LeBonheur Children's Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Louisiana State Univ/Children's Hospital of New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Phoenix Children's Hospital - Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Nemours Children's Health System Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.