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RELAXaHEAD for Headache Patients (Phase III)

Primary Purpose

Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RELAXaHEAD Smartphone App Version 1
RELAXaHEAD Smartphone App Version 2
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, Smartphone App, Headache Diary, Headache Tracking

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English speaking. (At this time, the validated app is only available in English.) ≥16 years of age Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on Information in the Study Manual Headaches for ≥1 year with a stable pattern for the past >3 months Agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month)) MSQv2 score <75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention) Exclusion Criteria: Patients who have had CBT, 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 Diagnosis of medication overuse headache and/or opioid or barbiturate use PHQ-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores >15, more intense 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 suffer from medication overuse) Unable or unwilling to follow a treatment program that relies on written and audio-taped materials Not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals). Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RELAX Group 1

RELAX Group 2

Arm Description

Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.

Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.

Outcomes

Primary Outcome Measures

Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score
5-item scale designed to measure disability over the previous 4 weeks. The total score is the sum of missed days due to a migraine from paid work, school, housework, and nonwork (family, social, and leisure) activities and days at paid work or housework where productivity was reduced by at least half. A decrease in scores indicates disability decreased during the observational period.

Secondary Outcome Measures

Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores
14-item self-assessment of how migraine affects a patient's life. Items ranked on a 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of the time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.
Change in Monthly Headache Days (MHDs)
MHDs data derived from the mMIDAS questionnaire and electronic diary.

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT06077838
Brief Title
RELAXaHEAD for Headache Patients (Phase III)
Official Title
A Single-Center Phase 3 Study of RELAXaHEAD: A Behavioral Approach to Remote Migraine Management in Primary Care
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 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
Detailed Description
Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Smartphone App, Headache Diary, Headache Tracking

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RELAX Group 1
Arm Type
Active Comparator
Arm Description
Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials.
Arm Title
RELAX Group 2
Arm Type
Active Comparator
Arm Description
Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials.
Intervention Type
Behavioral
Intervention Name(s)
RELAXaHEAD Smartphone App Version 1
Intervention Description
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts.
Intervention Type
Behavioral
Intervention Name(s)
RELAXaHEAD Smartphone App Version 2
Intervention Description
RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials.
Primary Outcome Measure Information:
Title
Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score
Description
5-item scale designed to measure disability over the previous 4 weeks. The total score is the sum of missed days due to a migraine from paid work, school, housework, and nonwork (family, social, and leisure) activities and days at paid work or housework where productivity was reduced by at least half. A decrease in scores indicates disability decreased during the observational period.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores
Description
14-item self-assessment of how migraine affects a patient's life. Items ranked on a 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of the time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.
Time Frame
Baseline, Week 6
Title
Change in Monthly Headache Days (MHDs)
Description
MHDs data derived from the mMIDAS questionnaire and electronic diary.
Time Frame
Baseline, Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking. (At this time, the validated app is only available in English.) ≥16 years of age Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on Information in the Study Manual Headaches for ≥1 year with a stable pattern for the past >3 months Agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month)) MSQv2 score <75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention) Exclusion Criteria: Patients who have had CBT, 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 Diagnosis of medication overuse headache and/or opioid or barbiturate use PHQ-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores >15, more intense 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 suffer from medication overuse) Unable or unwilling to follow a treatment program that relies on written and audio-taped materials Not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals). Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
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
929-455-5584
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: 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 mia.minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

RELAXaHEAD for Headache Patients (Phase III)

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