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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RECRUITING
NA
356 participants
INTERVENTIONAL
2023-11-08
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RELAX Group 1
Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.
RELAXaHEAD Smartphone App Version 1
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
RELAX Group 2
Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.
RELAXaHEAD Smartphone App Version 2
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.
Interventions
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RELAXaHEAD Smartphone App Version 1
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
RELAXaHEAD Smartphone App Version 2
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.
Eligibility Criteria
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Inclusion Criteria
* ≥16 years of age
* Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on Information in the Study Manual
* Headaches for ≥1 year with a stable pattern for the past \>3 months
* Agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study
* 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (\>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month))
* MSQv2 score \<75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention)
Exclusion Criteria
* Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
* Diagnosis of medication overuse headache and/or opioid or barbiturate use
* PHQ-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores \>15, more intense 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 suffer from medication overuse)
* Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
* Not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals).
* Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
16 Years
80 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
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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Central Contacts
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Other Identifiers
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22-01208
Identifier Type: -
Identifier Source: org_study_id
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