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

Primary Purpose

Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RELAXaHEAD Smartphone App
In-Person Training
Virtual Training
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Self-Management, Headache, Behavioral Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

In-Person Migraine Self-Management

Remote Migraine Self-Management

Arm Description

Outcomes

Primary Outcome Measures

Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
Number of Days of At-Home Practice
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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT06077812
Brief Title
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Official Title
NYU Langone Health Headache Center Learning Migraine Self-Management Techniques Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Self-Management, Headache, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Person Migraine Self-Management
Arm Type
Active Comparator
Arm Title
Remote Migraine Self-Management
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
RELAXaHEAD Smartphone App
Intervention Description
Participants will receive access to the smartphone application RELAXaHEAD, which contains features for migraine self-management including a headache diary.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Training
Intervention Description
Participants will receive in-person training in migraine self-management techniques.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Training
Intervention Description
Participants will receive virtual training in migraine self-management techniques.
Primary Outcome Measure Information:
Title
Number of In-Person Sessions Attended by Participants in the In-Person Migraine Self-Management Arm
Time Frame
Up to Month 2
Title
Number of Days of At-Home Practice
Time Frame
Up to Month 2
Title
Satisfaction Scores
Description
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.
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mia T Minen, MD
Phone
2122637744
Email
Mia.minen@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Waire
Phone
9294555584
Email
Erin.waire@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia T Minen, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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