NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
NCT ID: NCT06077812
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-11-27
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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In-Person Migraine Self-Management
RELAXaHEAD Smartphone App
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
In-Person Training
Participants will receive in-person training in migraine self-management techniques.
Remote Migraine Self-Management
RELAXaHEAD Smartphone App
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
Virtual Training
Participants will receive virtual training in migraine self-management techniques.
Interventions
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RELAXaHEAD Smartphone App
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
In-Person Training
Participants will receive in-person training in migraine self-management techniques.
Virtual Training
Participants will receive virtual training in migraine self-management techniques.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Mia T Minen, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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22-01149
Identifier Type: -
Identifier Source: org_study_id