Villanova University
Villanova, Pennsylvania, 19085, United States
NCT Number: NCT04921228
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Villanova, Pennsylvania, 19085, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Consent interview/Baseline assessment - Week 0
Measured by calculating the proportion of the people contacted who initially agree to participate in the study, defined as individuals who complete the baseline assessment following consent.
This will assess feasibility to establish interest in HRV biofeedback among eligible participants from the CHAMPS registry.
Time frame: Participant receipt of study device and initial study visit - Week 2
Measured by calculating the proportion of the people who pre-enroll in the study who complete their first study visit that introduces the use of the HRV biofeedback app.
This will assess feasibility to fully enroll participants in the HRV biofeedback protocol once they have agreed to participate and receive the device.
Time frame: Begins as soon the participant begins biofeedback training through the end of HRV biofeedback intervention - 8 weeks total
Measured by calculating: a) the proportion of the fully enrolled participants meeting pre-determined study engagement criteria (i.e., =>28 days of the 42 where a minimum of 10 minutes of biofeedback is completed), and b) the total number of minutes of biofeedback training logged over the 8-week protocol.
This will assess intervention's acceptability and serve as a measure of participant engagement
*There is a change in this section from what was originally posted. The PI noticed a discrepancy between Aims stated on the funded grant proposal and ClinicalTrials.gov record therefore we fixed ClinicalTrials.gov so that it reflected the grant's Aims statement.
Time frame: Training visit through final check-in and post-intervention assessments (approximately 10 weeks of study involvement
Measured by calculating the proportion of fully enrolled participants who complete the pilot study.
This is to assess feasibility of program implementation.
Time frame: post-intervention assessment (approximately 8 weeks after HRV biofeedback training visit)
Measured by calculating: a) the proportion of participants who rate HRV biofeedback practice as at least "moderately useful" (=>3 on a 1-5 Likert scale), and b) the proportion of participants who are at least "likely" (=>4 on a 1-5 Likert scale) to continue with their HRV biofeedback once the study ends.
This is to assess the usability of HRV biofeedback in this population.
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
Measured using the Eating Disorder Examination-Questionnaire 7-itemBrief, (EDE-Q7 Range: 0-6, higher scores indicate worse outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
Measured using the Loss of Control Eating Scale-7 item Brief (LOCES-Brief Range: 1-5, higher scores indicate worse outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Perceived Stress Scale, (PSS Range: 0-40, higher scores indicate worse outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Mindful Self-Care Scale, (MSCS Range: depends on dimension, higher scores indicate better outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Multidimensional Assessment of Interoceptive Awareness - Version 2, (MAIA-v2 Range: 0-5, higher scores indicate better outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Hunger and Satiety subscale of the Intuitive Eating Scale-2 (IES-2 Range: 1-5, higher scores indicate better outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Body Appreciation Scale-2 (BAS-2 Range: 1-5, higher scores indicate better outcome)
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Measured using the Sense of Coherence Scale Revised (SOC-R Range: depends on dimension, higher scores indicate better outcome)
Time frame: baseline, post intervention (approximately 10 weeks after baseline assessment)
Measured using the average daily RMSSD pre and post HRV biofeedback training
Villanova University
Other
Heart Rate Variability Biofeedback in Healthcare Providers During COVID-19: A Pilot Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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