RELAXaHEAD for Headache Patients (Phase I)

NCT03183791 | Completed

• 1 other identifier: 17-00525
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Headache; Migraine; Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

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

  Measure of feasibility

  90 Days

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

  Measure of feasibility

  90 Days

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

  Measure of feasibility

  90 Days

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

  Measure of acceptability

  Baseline

Study Arms (2)

RELAX group

EXPERIMENTAL

Behavioral: RELAXaHEAD app

Monitored Usual Care (MUC) group

ACTIVE COMPARATOR

Behavioral: Monitored Usual Care (MUC)

Interventions

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.

RELAX group

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.

Monitored Usual Care (MUC) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders; Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Mia Minen, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: November 1, 2017
• Primary Completion: May 25, 2019
• Study Completion: May 25, 2019
• Last Updated: July 11, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)