RELAXaHEAD for Headache Patients (Phase I)

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 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).

Official Title
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RELAXaHEAD for Headache Patients (Phase I)

Conditions
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Headache, Migraine, Multiple Sclerosis

Intervention / Treatment
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* Behavioral: RELAXaHEAD app
* Behavioral: Monitored Usual Care (MUC)


Participation Criteria
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Eligibility Criteria
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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

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 group<br> | Behavioral: RELAXaHEAD app<br>* 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.<br>|
| Active Comparator: Monitored Usual Care (MUC) group<br> | Behavioral: Monitored Usual Care (MUC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days spent logging headache data as determined by entries into the RELAXaHEAD app | Measure of feasibility | 90 Days | 
| 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 | 90 Days | 
| Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app | Measure of feasibility | 90 Days | 
| Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality | Measure of acceptability | Baseline |