RELAXaHEAD for Headache Patients (Phase I)

Multiple Sclerosis Clinical Trial

Official title:

RELAXaHEAD for Headache Patients (Phase I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183791
• Other study ID #: 17-00525
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 25, 2019

Study information

• Verified date: February 2020
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Multiple Sclerosis

Intervention

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 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)
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days spent logging headache data as determined by entries into the RELAXaHEAD app	Measure of feasibility	90 Days
Primary	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
Primary	Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app	Measure of feasibility	90 Days
Primary	Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality	Measure of acceptability	Baseline