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| ID | Type | Description | Link |
|---|---|---|---|
| K01NS124911 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -
After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Random - ME | Active Comparator | participants will be randomized to an intervention involving regular mealtime and regular timed exercise |
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| Random - MS | Active Comparator | participants will be randomized to an intervention involving regular mealtime and regular sleep |
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| Random - SE | Active Comparator | participants will be randomized to an intervention involving regular sleep and regular timed exercise |
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| Choice - ME | Active Comparator | this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise |
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| Choice - MS | Active Comparator | this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Migraine Behavioral Treatment | Behavioral | Migraine Behavioral Treatment involving daily activities |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility in terms of recruitment and adherence rates | recruitment rate, adherence rate | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Frequency | migraine day frequency | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization |
| Headache Self-efficacy | headache self-efficacy measured using validated headache self-efficacy questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yohannes W. Woldeamanuel, MD | Contact | 480-342-1385 | Woldeamanuel.YohannesWoubishet@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yohannes W. Woldeamanuel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32071349 | Background | Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1. | |
| 26810728 | Background | Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25. |
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all IPD that underlie results in a publication
starting 6 months after publication, for 2 years
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Choice - SE |
| Active Comparator |
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise |
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| at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization |
| Migraine Intensity | migraine intensity, self-reported | at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization |
| 34357593 | Background | Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |