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RELAXaHEAD for Headache Patients (Phase III) | Clinical Trials | Clareo Health

RECRUITINGNA

RELAXaHEAD for Headache Patients (Phase III)

A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care

NCT06077838•NYU Langone Health

View on ClinicalTrials.gov

Summary

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

Detailed Description

Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.

Eligibility

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

November 8, 2023

Primary Completion Date

August 31, 2028

Completion Date

August 31, 2028

Last Updated

October 10, 2025

Enrollment

356

ESTIMATED participants

Conditions

Migraine

Interventions

RELAXaHEAD Smartphone App Version 1

BEHAVIORAL

RELAXaHEAD Smartphone App Version 2

BEHAVIORAL

Contacts

Mia T Minen, MD

CONTACT

212-263-7744 Mia.minen@nyulangone.org

Erin Waire

CONTACT

929-455-5591 Erin.Waire@nyulangone.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RELAXaHEAD for Headache Patients (Phase III)

Inclusion Criteria

Exclusion Criteria

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