Heartmath Migraine Study

NYU Langone Health52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Migraine

Interventions

HeartMathBEHAVIORAL

HeartMath is a program where individuals learn heart rate variability biofeedback. Essentially, they learn breathing exercises that reduce their heart rate. The HeartMath program will be administered via an application on the smartphone and ear monitor.

Waitlist ControlBEHAVIORAL

Standard of Care Migraine Treatment

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Doing any form of behavioral therapy for pain in the past year

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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

Measured by comparing the slope of reduction in MSQv2 scores

Time frame: 8 Weeks

Secondary Outcomes

Change in depression

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

Time frame: 8 Weeks

Change in anxiety

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.

Time frame: 8 Weeks

Change insomnia

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).

Time frame: 8 Weeks

Data from ClinicalTrials.gov

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