Headache, Insomnia, Migraine, Multiple Sclerosis
Conditions
Keywords
Progressive Muscle Relaxation Therapy, Migraine, Insomnia
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).
Interventions
BEHAVIORALMonitored Usual Care (MUC)
Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.
BEHAVIORALSmartphone-Based Progressive Muscle Relaxation Therapy (PMR)
Relaxation technique delivered via RELAXaHEAD app.
Sponsors
Center for Advancing Point of Care Technologies
National Heart, Lung, and Blood Institute (NHLBI)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Enrolled in the Study | Baseline | Measure of feasibility. |
| Daily Diary Satisfaction Scores | Baseline | 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 | Baseline | 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 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. |
| Number of Days Participants Used Diary | Up to Month 3 | Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR): Relaxation technique delivered via RELAXaHEAD app. | 24 |
| 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.
Monitored Usual Care (MUC): Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | RELAX | Total | Monitored Usual Care (MUC) |
|---|---|---|---|
| Age, Continuous | 43.5 years | 44.2 years | 44.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 32 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) White | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 24 participants | 48 participants | 24 participants |
| Sex/Gender, Customized Female | 20 Participants | 42 Participants | 22 Participants |
| Sex/Gender, Customized Male | 4 Participants | 5 Participants | 1 Participants |
| Sex/Gender, Customized Other | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
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.
Time frame: Month 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Daily Diary Satisfaction Scores | 3.7 score on a scale | Standard Deviation 1.1 |
| Monitored Usual Care (MUC) | Daily Diary Satisfaction Scores | 3.4 score on a scale | Standard Deviation 1.1 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Daily Diary Satisfaction Scores | 4.2 score on a scale | Standard Deviation 0.6 |
| Monitored Usual Care (MUC) | Daily Diary Satisfaction Scores | 4.2 score on a scale | Standard Deviation 0.3 |
Primary
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.
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Daily Diary Satisfaction Scores | 4.4 score on a scale | Standard Deviation 0.6 |
| Monitored Usual Care (MUC) | Daily Diary Satisfaction Scores | 4.2 score on a scale | Standard Deviation 0.6 |
Primary
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.
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Daily Diary Satisfaction Scores | 3.9 score on a scale | Standard Deviation 0.9 |
| Monitored Usual Care (MUC) | Daily Diary Satisfaction Scores | 3.4 score on a scale | Standard Deviation 1 |
Primary
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.
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Daily Diary Satisfaction Scores | 3.6 score on a scale | Standard Deviation 1.1 |
| Monitored Usual Care (MUC) | Daily Diary Satisfaction Scores | 3.4 score on a scale | Standard Deviation 0.9 |
Primary
Number of Days Participants Used Diary
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Time frame: Up to Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Number of Days Participants Used Diary | 54.58 Days | Standard Deviation 31.88 |
| Monitored Usual Care (MUC) | Number of Days Participants Used Diary | 62.08 Days | Standard Deviation 27.27 |
Primary
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.
Time frame: Up to Month 3
Population: Monitored Usual Care (MUC) participants did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day | 22.1 Days | Standard Deviation 27.6 |
Primary
Number of Patients Enrolled in the Study
Measure of feasibility.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RELAX | Number of Patients Enrolled in the Study | 24 Participants |
| Monitored Usual Care (MUC) | Number of Patients Enrolled in the Study | 24 Participants |
Primary
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
Time frame: Month 1
Population: Monitored Usual Care (MUC) participants did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 3.5 score on a scale | Standard Deviation 1.2 |
Primary
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
Time frame: Month 2
Population: Monitored Usual Care (MUC) participants did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 3.5 score on a scale | Standard Deviation 1.1 |
Primary
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
Time frame: Month 3
Population: Monitored Usual Care (MUC) participants did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 3.9 score on a scale | Standard Deviation 1.1 |
Primary
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
Time frame: Week 1
Population: Monitored Usual Care (MUC) participants did not have data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 4 score on a scale | Standard Deviation 0.7 |
Primary
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RELAX | Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants | 3.7 score on a scale | Standard Deviation 0.7 |