Heartmath Migraine Study

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: HeartMath; Behavioral: Waitlist Control

• Registration Number: NCT04077658
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a two arm study comparing smartphone based heart rate variability biofeedback using the HeartMath app and InnerBalance sensor to waitlist control on migraine quality of life.

Detailed Description

The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life. Investigators will also look:

* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in depression in people with migraine.

* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in anxiety in people with migraine.

* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in insomnia in people with migraine.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-16
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-04
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• International Classification of Headache Disorders (ICHD) 3 criteria for migraine
• 4-20 headache days/month
• Has not done behavioral therapy for migraine in the past year
• Has a smartphone and willing to try HRV biofeedback using an app and ear monitor
• English speaking
• HS graduate or higher level of education
• Patients must not make preventive medication changes for the course of the study. If patients just changed their preventive medication, they must wait a month before enrolling.

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Exclusion Criteria

• Doing any form of behavioral therapy for pain in the past year

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	HeartMath	-
HeartMath	HeartMath	-
Waitlist Control	Waitlist Control	-

Primary Outcome Measures

Name	Time	Method
To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life	8 Weeks	Measured by comparing the slope of reduction in MSQv2 scores

Secondary Outcome Measures

Name	Time	Method
Change insomnia	8 Weeks	Measured using slope of reduction in Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Change in anxiety	8 Weeks	Measured using slope of reduction in eight-item Patient Health Questionnaire depression scale (PHQ-8), The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms.
Change in depression	8 Weeks	Measured using slope in reduction of Generalized Anxiety Disorder 7-item (GAD-7) scale. Average scores of 5-9: Mild; 10\*-14:Moderate; \>15:Severe

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States