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Completed

NCT Number: NCT06077812

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RELAXaHEAD Smartphone App

Behavioral

Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.

In-person training

Behavioral

Participants will receive in-person training in migraine self-management techniques.

Virtual training

Behavioral

Participants will receive virtual training in migraine self-management techniques.

Primary outcomes

  1. Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm

    Time frame: Up to Month 2

  2. Number of Days of At-Home Practice

    Time frame: Up to Month 2

  3. Satisfaction Scores

    Time frame: Month 2

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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