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.
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)]
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)
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Treatment groupsSee each treatment group below.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator