Comparing telehealth cognitive behavioral therapy for youth with migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Analyzing CGRP Levels in Migraine Patients by Age and Sex

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• Evaluating the effectiveness of rimegepant for treating migraines

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• Gepants for Acute Migraine in the Emergency Department

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.