RELAXaHEAD for Headache Patients (Phase III)

NCT ID
NCT06077838
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
NYU Langone Health
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 450 participants (Estimated).

What is being studied

  • Behavioral: RELAXaHEAD Smartphone App Version 1
  • Behavioral: RELAXaHEAD Smartphone App Version 2

Who may be eligible

Ages
16 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • NYU Langone Health — New York, New York, 10016, United States — Recruiting

Study details

Start date
November 8, 2023
Primary completion date
August 31, 2028
Completion date
August 31, 2028
First posted
October 11, 2023
Collaborators
National Institutes of Health (NIH)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06077838
Registry last updated
October 8, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT06077838 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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