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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077812
• Other study ID #: 22-01149
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Mia T Minen, MD
• Phone: 2122637744
• Email: Mia.minen[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Behavioral:
• RELAXaHEAD Smartphone App
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
• In-Person Training
Participants will receive in-person training in migraine self-management techniques.
• Virtual Training
Participants will receive virtual training in migraine self-management techniques.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm		Up to Month 2
Primary	Number of Days of At-Home Practice		Up to Month 2
Primary	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