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RELAXaHEAD for Headache Patients

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ClinicalTrials.gov Identifier: NCT03183791
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : January 25, 2018
National Multiple Sclerosis Society
Information provided by (Responsible Party):
New York University School of Medicine

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 has functionality to track medications. 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 data on the effects of the RELAX intervention on headache disability (Aim 2).

Condition or disease Intervention/treatment
Headache Migraine Post-Traumatic Headache Multiple Sclerosis Behavioral: RELAXaHEAD app Behavioral: Monitored Usual Care (MUC)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RELAXaHEAD for Headache Patients
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RELAX group
the RELAXaHEAD app
Behavioral: RELAXaHEAD app
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 the 5 minute PMR session and discuss the optimal time and place to practice PMR at home. Subjects will also enter their headache log daily on the app.
Active Comparator: Monitored Usual Care (MUC) group
this group receives standard of care and uses the electronic daily symptom reporting diary
Behavioral: Monitored Usual Care (MUC)
To match the time spent with the RV, patients will be given a general education session consisting of basic migraine information, such as evidence-based ways to treat headaches: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. The 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. All patients will be asked to track headache frequency, intensity, and acute medication use on app.

Primary Outcome Measures :
  1. Percentage of patients who did PMR ≥4/7 days of the week [ Time Frame: 6 Months ]
    Measure of feasibility

  2. Number of days spent doing PMR ≥5 minutes/day as determined with the backend analytics in the RELAXaHEAD app [ Time Frame: 6 Months ]
    Measure of feasibility

  3. Minutes/day spent doing PMR [ Time Frame: 6 Months ]
    Measure of feasibility

  4. Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality [ Time Frame: 6 Months ]
    Measure of acceptability

Secondary Outcome Measures :
  1. Migraine Disability Assessment Scale between scores at 3 months and baseline [ Time Frame: 3 Months ]
    Measure of functionality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
  • Migraine Disability Assessment (MIDAS) score >5.
  • OR
  • Meets Chronic PTH criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap) and had 4+ headache days a month, is 3-12 months post initial injury

Exclusion Criteria:

  • Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy 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
  • PHQ9 score of severe depression
  • Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
  • Not having a smartphone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183791

Contact: Mia Minen, MD, MPH 212-263-7744 mia.minen@nyumc.org
Contact: Ashley Bagheri 6465012560 ashley.bagheri@nyumc.org

United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Ashley bagheri    646-501-2560    ashley.bagheri@nyumc.org   
Principal Investigator: Mia Minen, MD         
Sponsors and Collaborators
New York University School of Medicine
National Multiple Sclerosis Society

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03183791     History of Changes
Other Study ID Numbers: 17-00525
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Post-Traumatic Headache
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases