NCT04715685

Mind Body Balance for Pediatric Migraine

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Detailed description

In the United States, over 6 million children and adolescents suffer from migraine headaches and it is 1 of the 5 most prevalent childhood disorders. Mind and body approaches can significantly help these youth, but getting access to this type of treatment is a challenge for families. Our mind and body study will test a mind and body intervention package delivered by health care professionals (i.e., nurses) introducing coping skills to youth ages 10 to 17 that have migraine. Using a factorial design and the multiphase optimization strategy "MOST", in this study we are able to evaluate different doses of 3 treatment components (1. Duration of mind and body skill introduction session; 2. Home practice support intensity; and 3. Adherence prompt phone call) in one project. A screening experiment will be conducted to determine the dose of each treatment component for future evaluation of the optimized intervention package in a pragmatic or SMART trial.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	40 minute session	The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group.
BEHAVIORAL	20 minute session	For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group.
BEHAVIORAL	home practice e-health	Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices.
BEHAVIORAL	home practice handout	Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.
BEHAVIORAL	phone call	The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion.

Timeline

• Start date: 2021-03-09
• Primary completion: 2026-05-01
• Completion: 2026-05-31
• First posted: 2021-01-20
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States