Evaluating a smartphone app for migraine management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the RELAXaHEAD smartphone app in managing migraines through a remote randomized control trial. Participants with migraines will be recruited from various primary care practices and randomized into two groups to receive different versions of the app. The study will assess the benefits of the app over a period of 6 weeks, with follow-up evaluations extending to 26 weeks post-treatment to determine the persistence of effects. Additionally, the study aims to explore mechanisms and identify subgroups of patients who may benefit most from the intervention.

Why it matters

Who can join: the full rules

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 it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Mia T Minen, MD — NYU Langone Health
• Study coordinator: Mia T Minen, MD
• Email: Mia.minen@nyulangone.org
• Phone: 212-263-7744

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.