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Completed

NCT Number: NCT05466682

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).

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Key information

Conditions

Migraine Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyssomnias Headache Headache Disorders Headache Disorders, Primary Immune System Diseases Insomnia Mental Disorders Migraine Disorders Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)

Behavioral

Relaxation technique delivered via RELAXaHEAD app.

Monitored Usual Care (MUC)

Behavioral

Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.

Primary outcomes

  1. Number of Patients Enrolled in the Study

    Time frame: Baseline

    Measure of feasibility.

  2. Daily Diary Satisfaction Scores

    Time frame: 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.

  3. Daily Diary Satisfaction Scores

    Time frame: Week 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.

  4. Daily Diary Satisfaction Scores

    Time frame: 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.

  5. Daily Diary Satisfaction Scores

    Time frame: 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.

  6. Daily Diary Satisfaction Scores

    Time frame: Month 3

    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.

  7. Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants

    Time frame: 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

  8. Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants

    Time frame: Week 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

  9. Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants

    Time frame: 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

  10. Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants

    Time frame: 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

  11. Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants

    Time frame: Month 3

    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

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

    Time frame: Up to Month 3

    Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.

  13. Number of Days Participants Used Diary

    Time frame: Up to Month 3

    Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Center for Advancing Point of Care Technologies
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 20, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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