RELAXaHEAD for Headache Patients (Phase II)

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466682
• Other study ID #: 17-00525-2
• Status: Completed
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 19, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Headache
• Insomnia
• Migraine
• Migraine Disorders
• Multiple Sclerosis
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
Relaxation technique delivered via RELAXaHEAD app.
• Monitored Usual Care (MUC)
Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	Center for Advancing Point of Care Technologies, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Enrolled in the Study	Measure of feasibility.	Baseline
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.	Baseline
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.	Week 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.	Month 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.	Month 2
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.	Month 3
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	Baseline
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	Week 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	Month 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	Month 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	Month 3
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.	Up to Month 3
Primary	Number of Days Participants Used Diary	Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.	Up to Month 3