A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care
NYU Langone Health
Summary
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
Description
Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the interve…
Eligibility
- Age range
- 16–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BehavioralRELAXaHEAD 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.
- BehavioralRELAXaHEAD 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.
Location
- NYU Langone HealthNew York, New York