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

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06077812
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RELAXaHEAD Smartphone App
  • Behavioral: In-Person Training
  • Behavioral: Virtual Training
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm [Up to Month 2]

  2. Number of Days of At-Home Practice [Up to Month 2]

  3. Satisfaction Scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT06077812
Other Study ID Numbers:
  • 22-01149
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by NYU Langone Health
Migraine
Self-Management
Headache
Behavioral Intervention
Additional relevant MeSH terms:
Migraine Disorders
Headache

Study Results

No Results Posted as of Oct 11, 2023