Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) for Migraine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Migraine+5 More
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a smartphone app can help people with migraines and sleep problems. The app, RELAXaHEAD, uses progressive muscle relaxation to try and help with symptoms. The study will compare people who use the app to those who receive usual care. Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) is used to treat Migraine. In this trial, all patients will receive the active treatment, rather than a placebo. This therapy has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Migraine
  • Headache
  • Multiple Sclerosis
  • Insomnia

Treatment Effectiveness

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Month 3

Baseline
Number of Patients Enrolled in the Study
Baseline, Month 3
Change in Headache (HA) Intensity Over Past 30 Days
Change in Insomnia Severity Index Scores (ISI)
Change in Migraine Disability Assessment Scale (MIDAS) Scores
Change in Migraine-Specific Quality of Life Questionnaire-Version 2.1 (MSQv2.1) Scores
Change in Number of Headache (HA) Days Over Past 30 Days
Month 2
Daily Diary Satisfaction Scores
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants
Month 3
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score
Perceived Stress Scale (PSS) Scores
Up to Month 2
Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at least 5 Minutes/Day
Percentage of RELAX Arm Participants who Performed Progressive Muscle Relaxation Therapy (PMR) at least 4 Days Per Week
Up to Month 3
Number of Adverse Events (AEs)
Number of Days Per Week Treated with Medications

Trial Safety

Trial Design

2 Treatment Groups

Monitored Usual Care (MUC)
1 of 2
RELAX
1 of 2
Active Control
Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) · No Placebo Group · N/A

RELAX
Behavioral
Experimental Group · 1 Intervention: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) · Intervention Types: Behavioral
Monitored Usual Care (MUC)
Behavioral
ActiveComparator Group · 1 Intervention: Monitored Usual Care (MUC) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 3
Closest Location: NYU Langone Health · New York, NY
Photo of NYU Langone Health 1Photo of NYU Langone Health 2Photo of NYU Langone Health 3
2020First Recorded Clinical Trial
3 TrialsResearching Migraine
110 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,556 Previous Clinical Trials
46,915,039 Total Patients Enrolled
Center for Advancing Point of Care TechnologiesUNKNOWN
NYU Langone HealthLead Sponsor
1,236 Previous Clinical Trials
749,963 Total Patients Enrolled
7 Trials studying Migraine
669 Patients Enrolled for Migraine
Mia Minen, MDPrincipal InvestigatorNYU Langone Medical Center
5 Previous Clinical Trials
590 Total Patients Enrolled
4 Trials studying Migraine
590 Patients Enrolled for Migraine

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.