# Mind Body Balance for Pediatric Migraine

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2022 · $815,986

## Abstract

Project Summary
Mind and body approaches, specifically diaphragmatic breathing, progressive muscle relaxation, guided
imagery, and biofeedback, improve outcomes for children and adolescents with chronic pain. One prevalent
cause of chronic pain is migraine. Worldwide, it is the 2nd most disabling neurological disease. When youth learn
and practice mind and body skills, the number of headache days and associated disability are reduced. Typically,
trials have tested non-pharmacological intervention packages taught by psychologists, in face-to-face sessions,
occurring over 4 to 8 weekly meetings. While efficacious, this model is not accessible to most families because
of lack of trained providers, distance and travel barriers, and time commitment to sessions. Our recent pilot
studies (both stakeholder engagement and health care provider skills training projects) show that youth who
receive outpatient psychological care report that learning breathing, muscle relaxation, guided imagery, and
biofeedback are the most useful and impactful components of the larger treatment package. Also, nurses in
headache centers report that they would feel comfortable with and are interested in learning how to introduce
these skills to patients; and pediatric headache specialists and primary care providers are searching for efficient
and effective ways to introduce mind and body skills to their patients. Thus, we need to conduct pragmatic trials
to test the delivery of these integrated approaches within the context of typical medical care to confirm if they
can provide benefit or not. But, despite evidence of safety, efficacy, and successful prior trial execution, it is
necessary to optimize a treatment package by evaluating which components and doses of a complex intervention
are critical for changes in outcomes prior to implementing a multi-site effectiveness trial. In this NCCIH U01, we
will optimize a migraine prevention treatment package focused on 4 mind and body skills that will be delivered
by health care providers (for this project, nurses) in two outpatient headache centers (Cincinnati & Denver). An
innovative intervention refinement approach, The Multiphase Optimization Strategy (MOST)
(https://methodology.psu.edu/ra/most) will be employed to determine necessary components and doses of an
efficient, effective treatment that can then be tested against standard care (patient education without any skills
 ≥
training) via a pragmatic trial. For this factorial experiment, we will enroll 200 youth ages 10 to 17 years with a
diagnosis of migraine who are experiencing 4 headache days per month (N = 25 per each of 8 conditions).
Three components will be tested: session time with nurses for introduction to the skills (dose of 20 or 40 minutes);
daily home practice of skills for 8 weeks (dose of a simple handout approach or use of an active, guided eHealth
application); and adherence prompt phone call at 1-month (dose of a call or no call). The endpoints are headache
d...

## Key facts

- **NIH application ID:** 10424441
- **Project number:** 5R01AT010132-03
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** SCOTT W POWERS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $815,986
- **Award type:** 5
- **Project period:** 2020-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10424441

## Citation

> US National Institutes of Health, RePORTER application 10424441, Mind Body Balance for Pediatric Migraine (5R01AT010132-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10424441. Licensed CC0.

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