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

N/A

Waitlist Available

Led By Mia Minen, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a smartphone app called RELAXaHEAD, which helps people with migraines and insomnia relax their muscles and track their headaches. The study aims to see if the app is easy to use and if it helps improve headache and sleep symptoms. The RELAXaHEAD app includes an electronic headache diary and progressive muscle relaxation (PMR) intervention, which has been previously adapted for smartphone applications for other conditions.

Eligible Conditions

Migraine
Multiple Sclerosis
Insomnia
Headache

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily Diary Satisfaction Scores

Number of Days Participants Used Diary

Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day

+2 more

Secondary study objectives

Change in Headache (HA) Intensity Over Past 30 Days

Change in Number of Headache (HA) Days Over Past 30 Days

Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RELAXExperimental Treatment1 Intervention

Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following: * Week 1: 5 min deep breathing at least 5/7 days of the week * Week 2: 5 min PMR session at least 5/7 days of the week * Week 3: 15 min PMR session at least 5/7 days of the week * Week 4: PMR at least 4 days a week * Week 5: PMR at least 3 days a week * Weeks 6-8: Use PMR when it is most helpful Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine.

Group II: Monitored Usual Care (MUC)Active Control1 Intervention

Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)

2022

N/A

~50

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