RELAXaHEAD for Headache Patients (Phase II)

RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Migraine; Insomnia; Headache
• Intervention / Treatment: Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR); Behavioral: Monitored Usual Care (MUC)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Enrolled in the Study	Measure of feasibility.	Baseline
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.	Month 1
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.	Month 2
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.	Baseline
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.	Week 1
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.	Month 3
Number of Days Participants Used Diary	Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.	Up to Month 3
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	Baseline
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	Week 1
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	Month 1
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	Month 2
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	Month 3
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.	Up to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Enrolled in the Study	Measure of feasibility.	Baseline
Percentage of RELAX Arm Participants who Performed Progressive Muscle Relaxation Therapy (PMR) at least 4 Days Per Week	Measure of feasibility.	Up to Month 2
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.	Up to Month 2
Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants	Measure of feasibility	Up to Month 2
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.	Month 1
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.	Month 2
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	Month 1
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	Month 2
Change in Number of Headache (HA) Days Over Past 30 Days	Measured by electronic HA diary data. Days start and end at midnight.	Baseline, Month 3
Change in Headache (HA) Intensity Over Past 30 Days	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	Baseline, Month 3
Number of Days Per Week Treated with Medications	Self-reported on the RELAXaHEAD app. Medications included: Non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, caffeine, aspirin, triptans, barbiturates, opioids, and antipsychotics.	Up to Month 3
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.	Baseline
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.	Month 1
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.	Month 2
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.	Month 3
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score	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.	Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score	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.	Month 1
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score	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.	Month 2
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress: Anxiety Score	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.	Month 3
Perceived Stress Scale (PSS) Scores	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.	Baseline
Perceived Stress Scale (PSS) Scores	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.	Month 1
Perceived Stress Scale (PSS) Scores	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.	Month 2
Perceived Stress Scale (PSS) Scores	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.	Month 3
Number of Adverse Events (AEs)	AEs recorded in real time by patients in the study diary.	Up to Month 3

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Center for Advancing Point of Care Technologies
• Investigators: Principal Investigator: Mia Minen, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Insomnia; Progressive Muscle Relaxation Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 17-00525-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No