Migraine Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado/Children's Hospital Colorado | Aurora | Colorado |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility and adherence to the session time component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the session time component a threshold of reasonable feasibility/adherence is specified as: nurse fidelity to introduction dose times (20 min versus 40 min) with fidelity measured as proportion of interactions where the documented time is within 5 minutes of the intended duration (i.e., 15 to 25 minutes for the 20-minute dose and 35 to 45 minutes for the 40-minute dose, as measured by nurse report at the time of the session). The acceptable threshold will be at least 80 percent fidelity within the given time window. | baseline to post treatment (8 weeks post randomization) | |
Other | Feasibility and adherence to the home practice component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the home practice component a threshold of reasonable feasibility/adherence is specified as: eHealth versus handout - threshold >33% of practice days completed on average will be defined as sufficient adherence for both conditions. | baseline to post treatment (8 weeks post randomization) | |
Other | Feasibility and adherence to the phone call component | Thresholds will be used as guides to evaluate whether the assigned intervention is feasible and whether participants can adhere to that intervention. For the phone call component a threshold of reasonable feasibility/adherence is specified as: 50% of phone calls completed will be considered feasible/adherent for the phone call follow-up. No threshold is set for the participants who do not receive a phone call follow-up. | baseline to post treatment (8 weeks post randomization) | |
Primary | Change in number of headache days | This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between the treatment groups over time. This will be assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days before the endpoint visit. | baseline to post treatment (8 weeks post randomization) | |
Secondary | Change in absolute headache disability score on PedMIDAS | The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. | baseline to post treatment (8 weeks post randomization) |
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