Short Sessions of HRV Biofeedback

Study Overview
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Brief Summary
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Remote 5 minute sessions of heart rate variability (HRV) biofeedback will be employed by participants for 5 weeks. Subjects will be followed for a total of 17 weeks. Surveys assessing psychological well being will be completed during the study period. Wearable devices will be worn to monitor HRV response during the study period.

Official Title
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Remote Short Sessions of Heart Rate Variability Biofeedback

Conditions
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Resilience

Intervention / Treatment
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* Behavioral: HRV Biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants were recruited from The Mount Sinai Hospital, Morningside Hospital, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai Queens, New York Eye and Ear Infirmary, and Mount Sinai Brooklyn. Eligible participants were 18 years of age or greater. Had an iPhone series 5 or greater. Had or were willing to wear an Apple Watch 4 or greater. Potential participants were excluded if they had an underlying chronic disease or used a medication that is known to impact autonomic nervous system function. Exclusion Criteria: Underlying chronic diseases including but not limited to: rheumatoid arthritis systemic lupus erythematosus inflammatory bowel disease Use of medications that impact heart rate variability including but not limited to: beta-blockers (ie. atenolol, carvedilol, metoprolol, Coreg, Tenormin, Normodyne, Trandate) digoxin calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem) regularly used benzodiazepines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRV Biofeedback<br>5 minute daily sessions of HRV biofeedback | Behavioral: HRV Biofeedback<br>* 5 minute daily sessions of HRV biofeedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | Heart rate variability measured in milliseconds (ms) at 7 weeks compared to baseline. Higher rates indicate increased parasympathetic nervous system activity. | Up to Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connor-Davidson Resilience Scale (CD-RISC | Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability. The CD-RISC is a 25-item self-administered scale. Scoring of the full 25 item scale is based on summing the total of each item, which is scored from 0-4. The full range is therefore from 0 to 100, with higher scores reflecting greater resilience. | Up to Week 17 |