RELAXaHEAD for Headache Patients (Phase III)
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Smartphone App, Headache Diary, Headache Tracking
Eligibility Criteria
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 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: Patients who have had CBT, 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 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)
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
RELAX Group 1
RELAX Group 2
Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.
Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.