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

Last updated: December 13, 2024
Sponsor: NYU Langone Health
Overall Status: Completed

Phase

N/A

Condition

Headaches

Chronic Pain

Migraine (Adult)

Treatment

In-Person Training

Virtual Training

RELAXaHEAD Smartphone App

Clinical Study ID

NCT06077812
22-01149
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 criteriabased 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 startuntil 3 months after beginning the study (Note - Acute medications may be changed ifneeded. Changes in preventive and acute medication and the time initiated will berecorded to evaluate the potential for medication confounds)

  • 4-29 headache days a month (so the study includes those in whom the investigatorstypically offer preventive treatment [>4 headache days/month] and those with morefrequent migraines including chronic migraine [15 days or more/month] but excludethose with continuous headaches)

Exclusion

Exclusion Criteria:

  • Diagnosis of Medication Overuse Headache (MOH)

  • Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other RelaxationTherapy for migraine in the past year

  • Alcohol or other substance abuse as determined by self-report or prior documentationin the medical record

  • Current opioid or barbiturate use

  • PHQ-8 scores greater than 15, indicating a conservative score of moderately severedepressive symptoms based on the PHQ-9 (in this group, more intense psychologicalintervention targeted to the depression may be needed, as depression is asignificant predictor of migraine chronification and people with migraine andcomorbid depression are more likely to be refractory to migraine treatments and todevelop medication overuse headache)

  • Unable or unwilling to follow a treatment program that relies on written andaudio-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 standardprotocol of biofeedback being studied

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: In-Person Training
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
December 10, 2024

Study 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.

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

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