Mind Body Balance for Pediatric Migraine
Mind Body Balance for Pediatric Migraine
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.
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.
Inclusion Criteria:

 -  Diagnosis: Migraine with or without aura or chronic migraine that meets the
 International Classification of Headache Disorders(ICHD) criteria

 -  Frequency: Headache frequency based upon prospective headache diary of 28 days must be
 ≥ 4 and ≤ 28.

 -  PedMIDAS: PedMIDAS Disability Score > 4, indicating at least mild disruption in daily
 activities and < 140, indicating extreme disability that may require more
 comprehensive, multi-component therapy

 -  Use of one or more of the following prescribed nutraceuticals and/or preventive
 anti-migraine medications at the time or randomization or be on a stable dose of one
 or more of the following throughout the 12 weeks of the study [Vitamin B2
 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3
 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil
 ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)]

 -  Language: English speaking, able to complete interviews and questionnaires in English

 Exclusion Criteria:

 -  Continuous migraine defined as unrelenting headache for a 28 day period

 -  Must agree not to take non-specific acute medication, such as NSAIDS (e.g.,
 ibuprofen), more than 3 times per week, or migraine specific acute medications, such
 as triptans, more than 6 times per month (to prevent medication overuse headache)

 -  PedMIDAS Disability Score > 140, indicating extreme disability that may require more
 comprehensive, multi-component therapy

 -  Youth who are pregnant, or those who are sexually active and not using a medically
 accepted form of contraception (barrier or hormonal methods)

 -  Present severe psychiatric disease, alcohol or drug dependence, or documented
 developmental delays or impairments (e.g., autism, cerebral palsy, or mental
 retardation) or other circumstances, that, in the opinion of the investigator, would
 interfere with adherence to study requirements or safe participation in the study