RELAXaHEAD for Headache Patients (Phase I)

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Headache; Migraine
• Interventions: Behavioral: Monitored Usual Care (MUC); Behavioral: RELAXaHEAD app

• Registration Number: NCT03183791
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Study Start: 2017-11-01
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25
• Status Verified: 2020-02
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monitored Usual Care (MUC) group	Monitored Usual Care (MUC)	-
RELAX group	RELAXaHEAD app	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States