RELAXaHEAD for Headache Patients (Phase II)

Not Applicable

Completed

Interventions: Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
Behavioral: Monitored Usual Care (MUC)

Brief Summary: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
RELAX	Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)	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.
Monitored Usual Care (MUC)	Monitored Usual Care (MUC)	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.

Primary Outcome Measures

Name	Time	Method
Daily Diary Satisfaction Scores	Month 3	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.
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants	Month 3	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
Number of Days Participants Used Diary	Up to Month 3	Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Number of Patients Enrolled in the Study	Baseline	Measure of feasibility.
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day	Up to Month 3	Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.