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Completed

NCT Number: NCT03183791

RELAXaHEAD for Headache Patients (Phase I)

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 is an electric headache diary. 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 exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).

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Key information

Conditions

Headache Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Headache Disorders Headache Disorders, Primary Immune System Diseases Migraine Migraine Disorders Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

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

  • Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
  • 4 or more headache days per month

Exclusion criteria

  • Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine 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 recorded materials
  • Not having a smartphone

Treatment and study plan

RELAXaHEAD app

Behavioral

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 a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.

Monitored Usual Care (MUC)

Behavioral

The Research Volunteers (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.

Subjects will be taught to enter their headache log daily on the app.

Primary outcomes

  1. Number of days spent logging headache data as determined by entries into the RELAXaHEAD app

    Time frame: 90 Days

    Measure of feasibility

  2. Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app

    Time frame: 90 Days

    Measure of feasibility

  3. Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app

    Time frame: 90 Days

    Measure of feasibility

  4. Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality

    Time frame: Baseline

    Measure of acceptability

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2017
Registry last updated
Jul 11, 2022

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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