Phase
Condition
Pain
Oral Facial Pain
Pain (Pediatric)
Treatment
RELAXaHEAD Smartphone App Version 1
RELAXaHEAD Smartphone App Version 2
Clinical Study ID
Ages 16-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
English speaking. (At this time, the validated app is only available in English.)
≥16 years of age
Meets International Classification of Headache Disorder (ICHD)-3 migraine criteriabased 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 thestart 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 offerpreventive treatment (>4 headache days/month and those with more frequent migrainesincluding chronic migraine but exclude those with continuous headaches (30days/month))
MSQv2 score <75 for role restrictive function to ensure participants have sufficientreduced quality of life to potentially benefit from the intervention (see if thereis a positive effect of the intervention)
Exclusion
Exclusion Criteria:
Patients who have had CBT, Biofeedback, or other Relaxation Therapy for migraine inthe past year
Alcohol or other substance abuse as determined by self-report or prior documentationin 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 severedepressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores >15, moreintense intervention targeted to the depression may be needed, as depression is asignificant predictor of migraine chronification and people with migraine andcomorbid depression are more likely to be refractory to migraine treatments and tosuffer from medication overuse)
Unable or unwilling to follow a treatment program that relies on written andaudio-taped materials
Not having a smartphone (we do not believe this exclusion criterion will adverselyaffect equitable subject selection because the subject population specific to ourresearch question would only be able to access this application via smartphone if itwere to become publicly available, including subjects without smartphones would notbe pertinent to our research question and overall study goals).
Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
Study Design
Study Description
Connect with a study center
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
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