NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study

The investigators aim to determine the feasibility of a migraine self-management program.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: RELAXaHEAD Smartphone App; Behavioral: In-Person Training; Behavioral: Virtual Training

Detailed Description

Patients with migraine seen by neurologists/headache specialists within or affiliated with the NYU Langone Health system will be identified via electronic medical record system, or in person. The investigators will randomize 50 participants to an in-person migraine self-management protocol, or a remote migraine self-management protocol. The investigators will examine benefits through follow-up at 2, 4, and 6 month time points.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking. (At this time, the validated app is only available in English.)
• 18-65 years of age
• Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on a headache specialist or neurologist
• Headaches for ≥1 year
• Has not begun a new migraine preventative medication in the last month
• Agreement to not make any preventive medication changes from the time of trial start until 3 months after beginning the study (Note - Acute medications may be changed if needed. Changes in preventive and acute medication and the time initiated will be recorded to evaluate the potential for medication confounds)
• 4-29 headache days a month (so the study includes those in whom the investigators typically offer preventive treatment [>4 headache days/month] and those with more frequent migraines including chronic migraine [15 days or more/month] but exclude those with continuous headaches)

Exclusion Criteria:

• Diagnosis of Medication Overuse Headache (MOH)
• Patients who have had Cognitive Behavioral Therapy, 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
• Current opioid or barbiturate use
• PHQ-8 scores greater than 15, indicating a conservative score of moderately severe depressive symptoms based on the PHQ-9 (in this group, more intense psychological 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 develop medication overuse headache)
• Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
• Coronary heart disease, heart attack, stroke, diabetes mellitus Type 1 or II
• Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
• Other physical limitations which would prevent participating in the standard protocol of biofeedback being studied

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-Person Migraine Self-Management	Behavioral: RELAXaHEAD Smartphone App; Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.; Behavioral: In-Person Training; Participants will receive in-person training in migraine self-management techniques.
Active Comparator: Remote Migraine Self-Management	Behavioral: RELAXaHEAD Smartphone App; Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.; Behavioral: Virtual Training; Participants will receive virtual training in migraine self-management techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm		Up to Month 2
Number of Days of At-Home Practice		Up to Month 2
Satisfaction Scores	Assessment of satisfaction with the intervention using a Likert scale from 1 to 5 with 1 being strongly disagree, and 5 being strongly agree; the total score is the response; higher scores indicate greater satisfaction with the intervention.	Month 2

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mia T Minen, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headache; Self-Management; Behavioral Intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 22-01149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Mia Minen (Mia.Minen@nyulangone.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Dr. Mia Minen (Mia.Minen@nyulangone.org). To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No