Actively Recruiting
RELAXaHEAD for Headache Patients (Phase III)
Led by NYU Langone Health · Updated on 2025-10-10
356
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
CONDITIONS
Official Title
RELAXaHEAD for Headache Patients (Phase III)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Age 16 years or older
- Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria
- Headaches for at least 1 year with a stable pattern for over 3 months
- Agreement to avoid changes in preventive medication for 3 months before and during the 6-week intervention
- Experiences 4 to 29 headache days per month
- MSQv2 score less than 75 for role restrictive function indicating reduced quality of life
You will not qualify if you...
- Received CBT, Biofeedback, or other relaxation therapy for migraine in the past year
- History of alcohol or substance abuse
- Diagnosis of medication overuse headache or use of opioids or barbiturates
- PHQ-8 score greater than 15 indicating moderately severe depressive symptoms
- Unable or unwilling to follow a program using written and audio materials
- Does not have a smartphone
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
M
Mia T Minen, MD
CONTACT
E
Erin Waire
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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