Biofeedback for CHAMPS

Villanova University

Status: Completed

Conditions: Disordered Eating; Stress

Treatments: Behavioral: Heart rate variability biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04921228

IRB-FY2021-233

Details and patient eligibility

About

As a result of the COVID-19 pandemic, the degree of burnout and consequential negative psychological effects experienced by healthcare providers has been substantially exacerbated. Heart rate variability (HRV) biofeedback has long been used to assist with a wide variety of stress-related concerns. Building on evidence that HRV biofeedback has the potential to improve wellbeing, the purpose of this study is to pilot test and determine the feasibility of implementing a digital HRV biofeedback tool to improve disordered eating, mindful self-care (i.e., self-compassion, body appreciation, etc.), and perceived stress in healthcare providers. In addition to assessing acceptability and feasibility of the HRV biofeedback tool, the investigators will aim to establish 'proof-of-concept' for a conceptual model consisting of potential psychological constructs underlying the mechanisms of change for the intervention-namely mind-body awareness (i.e., interoception) and resilience. Our primary recruitment pool will include healthcare providers who reported elevated eating distress as a participant in an ongoing observational study of the health effects of theCOVID-19 pandemic on essential workers (CHAMPS).

Full description

Previous research suggests healthcare professionals may be a population at high-risk for disordered eating. As a result of the COVID-19 pandemic, the degree of burnout and consequential negative psychological effects experienced by healthcare providers has been substantially exacerbated. In fact, in an ongoing study of essential workers during the COVID-19 pandemic, the investigators found over a third of nursing professionals endorsed clinically significant disordered eating. With the clear evidence showing a psychological toll of the COVID-19 pandemic among healthcare workers globally, addressing their wellbeing with feasible at-home interventions is a priority.

Heart rate variability (HRV) biofeedback has long been used to assist with a wide variety of stress-related concerns, including depression and anxiety (Lehrer et al., 2020), both conditions that commonly co-occur with disordered eating. Research suggests interoception (i.e., the capacity to detect and respond to signals from the body), is disrupted in those with eating disorders (Martin et al., 2019). While there is relatively sparse evidence on the relationship between HRV and interoception (Pinna & Edwards, 2020), it is theoretically plausible that superior interoception would predict improved vagal tone (i.e., parasympathetic activity) as measured by HRV. Moreover, data on HRV and disordered eating is mixed, and poorly understood (Watford et al., 2020). The present research seeks to begin addressing this gap in knowledge through a pilot feasibility study designed to initiate proof-of-concept for the development of a conceptual model.

Specifically, the study aims to:

1. assess the feasibility of implementing a digitally based HRV biofeedback protocol
2. assess the acceptability and usability of HRV biofeedback in healthcare providers with elevated disordered eating
3. examine signals of efficacy to begin building a conceptual model of the potential mechanisms underlying change in outcomes
4. test whether there is a relationship between intervention engagement/adherence and change in outcomes.

Participants will be recruited from a registry of healthcare providers enrolled in an ongoing study of the health effects of working during the COVID-19 pandemic (unless recruitment goals are not met using this method). This single arm feasibility pilot will provide the data to help determine the acceptability of using a smartphone based HRV biofeedback training tool as an intervention for this population and guide the refinement of the conceptual model being developed. By establishing feasibility and proof-of-concept, the study will build upon a limited body of work and establish an important first step towards understanding intervention dosing and signals of efficacy for aiding with disordered eating and related mind-body factors in this population.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Ability to speak and read English
3. Previously enrolled in the protocol titled "COVID-19 CHAMPS study" (IRB-FY2020-215) (ClinicalTrials.gov: NCT04370821)
4. Willing to be contacted about other studies (i.e., CHAMPS study participants who agreed to be contacted about future research opportunities)
5. Works in the healthcare professions
6. Elevated eating distress as indicated by Loss of Control Eating scores above the median of 2 in this cohort.
7. Owns either an iPhone or Android smartphone for running the app involved in the intervention

Exclusion criteria

1. History of a heart transplant or a pacemaker.
2. Uncontrolled kidney disease
3. Uncontrolled diabetes
4. Heart failure
5. COPD (Chronic Obstructive Pulmonary Disease)
6. Use of tricyclic antidepressant (e.g., nortriptyline, amitriptyline) above 75 mgs daily
7. Use of illicit stimulants (e.g., cocaine) or narcotic drugs
8. Inability to perform study protocol (self selected)
9. Current use of HRV biofeedback training

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Heart rate variability biofeedback

Experimental group

Description:

Heart rate variability biofeedback training will be administered via a smartphone app (Optimal HRV) that reads the participants' pulse rate through a Bluetooth connected photoplethysmography (PPG) sensor attached to the finger or thumb.

Treatment:

Behavioral: Heart rate variability biofeedback