NCT06077838 · NYU Langone Health
RELAXaHEAD for Headache Patients (Phase III)
What this study is about
This study is a fully powered, remote randomly assigned control trial to evaluate RELAXaHEAD in people with migraine.
View original scientific description
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
Interventions
BEHAVIORAL
RELAXaHEAD 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.
BEHAVIORAL
RELAXaHEAD 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.
Primary outcome measures
Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- New York, New York
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations