RELAXaHEAD for Headache Patients (Phase I)
Primary Purpose
Headache, Migraine, Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RELAXaHEAD app
Monitored Usual Care (MUC)
Sponsored by
About this trial
This is an interventional treatment trial for Headache
Eligibility Criteria
Inclusion Criteria:
- Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
- 4 or more headache days per month
Exclusion Criteria:
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine in the past year
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- Opioid or barbiturate use 10+ days a month
- Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
- Not having a smartphone
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RELAX group
Monitored Usual Care (MUC) group
Arm Description
Outcomes
Primary Outcome Measures
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
Measure of feasibility
Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
Measure of feasibility
Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
Measure of feasibility
Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
Measure of acceptability
Secondary Outcome Measures
Full Information
NCT ID
NCT03183791
First Posted
June 8, 2017
Last Updated
July 6, 2022
Sponsor
NYU Langone Health
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03183791
Brief Title
RELAXaHEAD for Headache Patients (Phase I)
Official Title
RELAXaHEAD for Headache Patients (Phase I)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Multiple Sclerosis Society
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
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RELAX group
Arm Type
Experimental
Arm Title
Monitored Usual Care (MUC) group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
RELAXaHEAD app
Intervention Description
The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.
Intervention Type
Behavioral
Intervention Name(s)
Monitored Usual Care (MUC)
Intervention Description
The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
Subjects will be taught to enter their headache log daily on the app.
Primary Outcome Measure Information:
Title
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
Description
Measure of feasibility
Time Frame
90 Days
Title
Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
Description
Measure of feasibility
Time Frame
90 Days
Title
Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
Description
Measure of feasibility
Time Frame
90 Days
Title
Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
Description
Measure of acceptability
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
4 or more headache days per month
Exclusion Criteria:
Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine in the past year
Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
Opioid or barbiturate use 10+ days a month
Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
Not having a smartphone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Minen, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RELAXaHEAD for Headache Patients (Phase I)
We'll reach out to this number within 24 hrs