RELAXaHEAD for Headache Patients (Phase II)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RELAX 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)
Relaxation technique delivered via RELAXaHEAD app.
|
| Active Comparator: 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. |
Behavioral: Monitored Usual Care (MUC)
Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.
|
Outcome Measures
Primary Outcome Measures
- Change in Migraine-Specific Quality of Life Questionnaire-Version 2.1 (MSQv2.1) Scores [Baseline, Month 3]
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.
- Change in Migraine Disability Assessment Scale (MIDAS) Scores [Baseline, Month 3]
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)
- Change in Insomnia Severity Index Scores (ISI) [Baseline, Month 3]
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)
Secondary Outcome Measures
- Number of Patients Enrolled in the Study [Baseline]
Measure of feasibility.
- Percentage of RELAX Arm Participants who Performed Progressive Muscle Relaxation Therapy (PMR) at least 4 Days Per Week [Up to Month 2]
Measure of feasibility.
- Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at least 5 Minutes/Day [Up to Month 2]
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
- Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants [Up to Month 2]
Measure of feasibility
- Daily Diary Satisfaction Scores [Month 1]
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.
- Daily Diary Satisfaction Scores [Month 2]
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 1]
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
- Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores among RELAX Arm Participants [Month 2]
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
- Change in Number of Headache (HA) Days Over Past 30 Days [Baseline, Month 3]
Measured by electronic HA diary data. Days start and end at midnight.
- Change in Headache (HA) Intensity Over Past 30 Days [Baseline, Month 3]
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
- Number of Days Per Week Treated with Medications [Up to Month 3]
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 [Baseline]
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 [Month 1]
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 [Month 2]
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 [Month 3]
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: Anxiety Score [Baseline]
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.
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score [Month 1]
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.
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score [Month 2]
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.
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score [Month 3]
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.
- Perceived Stress Scale (PSS) Scores [Baseline]
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.
- Perceived Stress Scale (PSS) Scores [Month 1]
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.
- Perceived Stress Scale (PSS) Scores [Month 2]
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.
- Perceived Stress Scale (PSS) Scores [Month 3]
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.
- Number of Adverse Events (AEs) [Up to Month 3]
AEs recorded in real time by patients in the study diary.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- Center for Advancing Point of Care Technologies
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Mia Minen, MD, NYU Langone Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-00525-2