Can a smartphone app ease the burden of migraines? new study aims to find out.
NCT ID NCT06077838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a remote behavioral program called RELAXaHEAD for people with migraines. About 356 adults will use the app to learn skills that may reduce migraine-related disability and improve quality of life. The goal is to see if this approach works better than usual care, all from the comfort of home.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 356 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Other studies related to the condition(s) this trial covers.
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