NCT03183791

RELAXaHEAD for Headache Patients (Phase I)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-05-25
• Completion: 2019-05-25
• First posted: 2017-06-12
• Last updated: 2022-07-11

Locations

1 site across 1 country: United States