NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study

Study Overview
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Brief Summary
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The investigators aim to determine the feasibility of a migraine self-management program.

Detailed Description
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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.

Official Title
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NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: RELAXaHEAD Smartphone App
* Behavioral: In-Person Training
* Behavioral: Virtual Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking. (At this time, the validated app is only available in English.) 18-65 years of age Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist Headaches for ≥1 year Has not begun a new migraine preventative medication in the last month Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds) 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment [>4 headache days/month] and those with more frequent migraines including chronic migraine [15 days or more/month] but exclude those with continuous headaches) Exclusion Criteria: Diagnosis of Medication Overuse Headache (MOH) Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy for migraine in the past year Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record Current opioid or barbiturate use PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to develop medication overuse headache) Unable or unwilling to follow a treatment program that relies on written and audio-taped materials Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes) Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person Migraine Self-Management<br> | Behavioral: RELAXaHEAD Smartphone App<br>* Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.<br>Behavioral: In-Person Training<br>* Participants will receive in-person training in migraine self-management techniques.<br>|
| Active Comparator: Remote Migraine Self-Management<br> | Behavioral: RELAXaHEAD Smartphone App<br>* Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.<br>Behavioral: Virtual Training<br>* Participants will receive virtual training in migraine self-management techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Self-Management, Headache, Behavioral Intervention