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The investigators aim to determine the feasibility of a migraine self-management program.
Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Migraine Self-Management | Active Comparator |
| |
| Remote Migraine Self-Management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELAXaHEAD Smartphone App | Behavioral | Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm | Up to Month 2 | |
| Number of Days of At-Home Practice | Up to Month 2 | |
| Satisfaction Scores | Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention. | Month 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia T Minen, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42220255 | Derived | Szuhany KL, Dorf J, Bostic RC, Fanning KM, Minen MT. Predictors of response to biofeedback-assisted relaxation for migraine: An exploratory analysis. Cephalalgia. 2026 Jun;46(6):3331024261441579. doi: 10.1177/03331024261441579. Epub 2026 Jun 1. |
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The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Mia Minen (Mia.Minen@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Dr. Mia Minen (Mia.Minen@nyulangone.org). To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| In-Person Training | Behavioral | Participants will receive in-person training in migraine self-management techniques. |
|
| Virtual Training | Behavioral | Participants will receive virtual training in migraine self-management techniques. |
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |