Comparing telehealth cognitive behavioral therapy for youth with migraines
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 study is testing whether online therapy for kids and teens with migraines works better when combined with medication or on its own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 15 sites (Birmingham, Alabama and 14 other locations) |
| Trial ID | NCT05889624 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy (CBT) delivered via telehealth for children and adolescents suffering from migraines. It will compare two groups: one receiving CBT alongside a clinically-prescribed medication (amitriptyline) and another receiving CBT alone. Participants will engage in a baseline period followed by six telehealth sessions and booster sessions over 28 weeks. The goal is to enhance access to effective migraine treatments and improve long-term outcomes for youth.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents diagnosed with migraines who experience four or more headache days per month and are eligible for amitriptyline treatment.
Not a fit: Patients currently receiving amitriptyline or CBT specific to headache care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for youth suffering from migraines.
How similar studies have performed: Previous studies have shown promising results for CBT in treating migraines, but this approach of combining telehealth with medication is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Birmingham, Alabama and 14 other locations
- University of Alabama at Birmingham Children's of Alabama — Birmingham, Alabama, United States (Recruiting)
- Phoenix Children's Hospital - Barrow Neurological Institute — Phoenix, Arizona, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- University of Colorado/Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Nemours Children's Health System — Wilmington, Delaware, United States (Recruiting)
- Clinical Integrative Research Center of Atlanta, Inc — Atlanta, Georgia, United States (Recruiting)
- University of Louisville Health/Norton — Louisville, Kentucky, United States (Recruiting)
- Louisiana State Univ/Children's Hospital of New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Dent Neurological Institute — Amherst, New York, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Childrens — Columbus, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Tennessee Health Science Center/ LeBonheur Children's Hospital — Memphis, Tennessee, United States (Recruiting)
- Dell Children's Hospital-UT Health — Austin, Texas, United States (Recruiting)
- Marshall Health — Huntington, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Scott Powers, PhD — Cincinnati Childrens Medical Center, Cincinnati
- Study coordinator: LeighAnn Chamberlin, MEd
- Email: leighann.chamberlin@cchmc.org
- Phone: 513-636-9739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.