RELAXaHEAD for Headache Patients (Phase III)

Recruiting · NCT06077838 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health

Interventions studied

RELAXaHEAD Smartphone App Version 1RELAXaHEAD Smartphone App Version 2

This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.

Age range

16 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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)

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)

1 location listed across 1 US state.