RELAXaHEAD for Headache Patients (Phase II)

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).

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.

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.

14-item self-assessment of how migraines affect a patient's life. Items ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of the time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.

5-item self-administered questionnaire designed to quantify headache-related disability over a 3-month period. For each item, participants indicate the number of days that migraine limited their ability to participant in specific activities. The score is the sum of responses. Scores are classified as follows: 0 to 5 = Little or no disability (MIDAS Grade I) 6 to 10 = Mild disability (MIDAS Grade II) 11 to 20 = Moderate disability (MIDAS Grade III) 21 and over = Severe disability (MIDAS Grade IV)

7-item self-assessment designed to assess the severity of both nighttime and daytime components of insomnia. Items are ranked on a 5-point Likert scale. The total score is the sum of responses. Total scores range from 0 to 28: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

Percentage of RELAX Arm Participants who Performed Progressive Muscle Relaxation Therapy (PMR) at least 4 Days Per Week

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

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.

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.

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

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

Measured by electronic HA diary data. Participants rank intensity on the following scale: 0 = no HA 1 = mild HA 2 = moderate HA 3 = severe HA

Self-reported on the RELAXaHEAD app. Medications included: Non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, caffeine, aspirin, triptans, barbiturates, opioids, and antipsychotics.

Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score

8-item self-assessment measuring symptoms of depression over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of depressive symptoms.

Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score

8-item self-assessment measuring symptoms of depression over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of depressive symptoms.

Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score

8-item self-assessment measuring symptoms of depression over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of depressive symptoms.

Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Depression Score

8-item self-assessment measuring symptoms of depression over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of depressive symptoms.

8-item self-assessment measuring symptoms of anxiety over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The total score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of anxiety symptoms.

8-item self-assessment measuring symptoms of anxiety over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The total score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of anxiety symptoms.

8-item self-assessment measuring symptoms of anxiety over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The total score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of anxiety symptoms.

8-item self-assessment measuring symptoms of anxiety over the past 7 days. Items ranked on 5-point Likert scale, where: 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Always. The total score is the sum of responses. Scores range from 8-40; higher scores indicate greater prevalence of anxiety symptoms.

10-item self-assessment measuring perception of stress. Items ranked on 5-point Likert scale, where: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; and 4 = Very often. Scores on the PSS range from 0-40; higher scores indicate higher perceived stress.

10-item self-assessment measuring perception of stress. Items ranked on 5-point Likert scale, where: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; and 4 = Very often. Scores on the PSS range from 0-40; higher scores indicate higher perceived stress.

10-item self-assessment measuring perception of stress. Items ranked on 5-point Likert scale, where: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; and 4 = Very often. Scores on the PSS range from 0-40; higher scores indicate higher perceived stress.

10-item self-assessment measuring perception of stress. Items ranked on 5-point Likert scale, where: 0 = Never; 1 = Almost never; 2 = Sometimes; 3 = Fairly often; and 4 = Very often. Scores on the PSS range from 0-40; higher scores indicate higher perceived stress.

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.

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Minen (PI). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to alexis.george@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.