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RELAXaHEAD for Headache Patients

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ClinicalTrials.gov Identifier: NCT03183791
Recruitment Status : Not yet recruiting
First Posted : June 12, 2017
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):

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 headaches. 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 has functionality to track medications. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. 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 headache (Aim 1) and to gather data on the effects of the RELAX intervention on headache disability (Aim 2).

Condition or disease Intervention/treatment
Headache Behavioral: RELAXaHEAD app Behavioral: Monitored Usual Care (MUC)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: RELAXaHEAD for Headache Patients
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RELAX group
the RELAXaHEAD app
Behavioral: RELAXaHEAD app
The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform the 5 minute PMR session and discuss the optimal time and place to practice PMR at home. Subjects will also enter their headache log daily on the app.
Active Comparator: Monitored Usual Care (MUC) group
this group receives standard of care and uses the electronic daily symptom reporting diary
Behavioral: Monitored Usual Care (MUC)
To match the time spent with the RV, patients will be given a general education session consisting of basic migraine information, such as evidence-based ways to treat headaches: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. The RV will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive. All patients will be asked to track headache frequency, intensity, and acute medication use on app.

Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients who enrolled in the study/were recruited for the study [ Time Frame: 6 Months ]
    Measure of feasibility

  2. Percentage of patients who did PMR ≥4/7 days of the week [ Time Frame: 6 Months ]
    Measure of feasibility

  3. Number of days spent doing PMR ≥5 minutes/day as determined with the backend analytics in the RELAXaHEAD app [ Time Frame: 6 Months ]
    Measure of feasibility

  4. Minutes/day spent doing PMR [ Time Frame: 6 Months ]
    Measure of feasibility

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
  • Migraine Disability Assessment (MIDAS) score >5.
  • OR
  • Meets Chronic PTH criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap) and had 4+ headache days a month, is 3-12 months post initial injury

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
  • PHQ9 score of severe depression
  • Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
  • ; Not having a smartphone
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03183791     History of Changes
Other Study ID Numbers: 17-00525
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms