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
402 participants
INTERVENTIONAL
2017-11-01
2019-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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RELAX group
RELAXaHEAD app
The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.
Monitored Usual Care (MUC) group
Monitored Usual Care (MUC)
The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
Subjects will be taught to enter their headache log daily on the app.
Interventions
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RELAXaHEAD app
The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.
Monitored Usual Care (MUC)
The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
Subjects will be taught to enter their headache log daily on the app.
Eligibility Criteria
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Inclusion Criteria
* 4 or more headache days per month
Exclusion Criteria
* Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
* Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
* Opioid or barbiturate use 10+ days a month
* Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
* Not having a smartphone
18 Years
80 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Mia Minen, MD
Role: PRINCIPAL_INVESTIGATOR
New York Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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17-00525
Identifier Type: -
Identifier Source: org_study_id
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