RELAXaHEAD for Headache Patients (Phase II)

Study Overview
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Brief Summary
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The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. 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. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . 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 migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).

Official Title
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RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep

Conditions
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Migraine, Headache, Multiple Sclerosis, Insomnia

Intervention / Treatment
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* Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
* Behavioral: Monitored Usual Care (MUC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years (age 18-65 in urgent care); Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria; Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month.OR Meets Chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month. Scoring > or = 15 on the ISI. 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; Unable or unwilling to follow a treatment program that relies on written and audio file materials; Not having a smartphone.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RELAX<br>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. | Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)<br>* Relaxation technique delivered via RELAXaHEAD app.<br>|
| Active Comparator: Monitored Usual Care (MUC)<br>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. | Behavioral: Monitored Usual Care (MUC)<br>* Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Month 3 | 
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Baseline | 
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Week 1 | 
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 1 | 
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 2 | 
| Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants | 4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction | Month 3 | 
| Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at least 5 Minutes/Day | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Up to Month 3 | 
| Number of Days Participants Used Diary | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. | Up to Month 3 | 
| Number of Patients Enrolled in the Study | Measure of feasibility. | Baseline | 
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Baseline | 
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Week 1 | 
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Month 1 | 
| Daily Diary Satisfaction Scores | 5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction. | Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive Muscle Relaxation Therapy, Migraine, Insomnia