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RELAXaHEAD for Migraine Patients

This study is looking for people with migraine to test two versions of a smartphone app called RELAXaHEAD. The app helps you track your headaches, sleep, and medications. Researchers want to see if using the app can improve your migraine disability, which is how much migraines affect your daily life. You might be able to join if you are 16 to 80 years old, speak English, and have had migraines for at least a year. The study is currently recruiting 356 participants.

Study design
This is a remote randomized control trial with 356 participants. It compares two different versions of the RELAXaHEAD smartphone app.
What's involved
You would use one of the RELAXaHEAD smartphone apps daily to track your headaches and other information. You would also agree not to change your preventive migraine medications for three months.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for effects up to 26 weeks after the treatment period.

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NCT06077838

RELAXaHEAD for Headache Patients (Phase III)

Recruiting
NAAges 16–80InterventionalTreatment
NYU Langone Health
~356 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:RELAXaHEAD Smartphone App Version 1RELAXaHEAD Smartphone App Version 2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score
Measured over Baseline, Week 6

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mia T Minen, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Mia T Minen, MD
[email protected]
212-263-7744
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) ScoreBaseline, Week 6

    5-item scale designed to measure disability over the previous 4 weeks. The total score is the sum of missed days due to a migraine from paid work, school, housework, and nonwork (family, social, and leisure) activities and days at paid work or housework where productivity was reduced by at least half. A decrease in scores indicates disability decreased during the observational period.