Recruiting

RELAXaHEADRELAXaHEAD for Headache Patients (Phase III)

Sponsor:

NYU Langone Health

Code:

NCT06077838

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

RELAXaHEAD Smartphone App Version 1

RELAXaHEAD Smartphone App Version 2

Study Details

Brief summary:

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

Conditions

Migraine

Study ID

NCT06077838

Start date

Nov 8, 2023

Status verified date

Oct, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: RELAX Group 1

Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.

active comparator: RELAX Group 2

Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.

Interventions

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.

RELAXaHEAD Smartphone App Version 2

Primary outcome measure

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score [ Time Frame: Baseline, Week 6 ]

Central Contacts and Locations

Central contacts

Mia T Minen, MD

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

Erin Waire

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

Migraine
Smartphone App
Headache Diary
Headache Tracking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.