Clinical trial NCT04921228: Biofeedback for CHAMPS
Official title: Heart Rate Variability Biofeedback in Healthcare Providers During COVID-19: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disordered Eating
Stress
Keywords: Heart rate variability biofeedback
Disordered eating
Eating Disorders
Perceived Stress
Interoception
Interoceptive awareness
Vagal tone
Mind-body approaches
Self-compassion
Resilience
Body appreciation
Self-care
Intuitive eating
Mindful awareness
Lead sponsor: Villanova University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-enrollment:
timeFrame: Consent interview/Baseline assessment - Week 0
measure: Full enrollment:
timeFrame: Participant receipt of study device and initial study visit - Week 2
measure: Engagement/adherence to protocol
timeFrame: Begins as soon the participant begins biofeedback training through the end of HRV biofeedback intervention - 8 weeks total
measure: Attrition/Drop out
timeFrame: Training visit through final check-in and post-intervention assessments (approximately 10 weeks of study involvement
measure: Usability
timeFrame: post-intervention assessment (approximately 8 weeks after HRV biofeedback training visit)
Secondary outcomes:
measure: Variation in disordered eating attitudes and behaviors
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
measure: Variation in disordered eating attitudes and behaviors
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
measure: Variation in perceived stress
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in mindful self-care
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in interoception
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in interoception
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in body appreciation
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in resilience
timeFrame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
measure: Variation in HRV
timeFrame: baseline, post intervention (approximately 10 weeks after baseline assessment)
Other outcomes:
Locations:
city: Villanova
country: United States
facility: Villanova University
state: Pennsylvania
Study officials:
affiliation: Villanova University
name: Janell Mensinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehrer P, Kaur K, Sharma A, Shah K, Huseby R, Bhavsar J, Sgobba P, Zhang Y. Heart Rate Variability Biofeedback Improves Emotional and Physical Health and Performance: A Systematic Review and Meta Analysis. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):109-129. doi: 10.1007/s10484-020-09466-z.
citation: Martin E, Dourish CT, Rotshtein P, Spetter MS, Higgs S. Interoception and disordered eating: A systematic review. Neurosci Biobehav Rev. 2019 Dec;107:166-191. doi: 10.1016/j.neubiorev.2019.08.020. Epub 2019 Aug 24.
citation: Pinna T, Edwards DJ. A Systematic Review of Associations Between Interoception, Vagal Tone, and Emotional Regulation: Potential Applications for Mental Health, Wellbeing, Psychological Flexibility, and Chronic Conditions. Front Psychol. 2020 Aug 5;11:1792. doi: 10.3389/fpsyg.2020.01792. eCollection 2020.
citation: Watford TS, Braden A, O'Brien WH. Resting state heart rate variability in clinical and subthreshold disordered eating: A meta-analysis. Int J Eat Disord. 2020 Jul;53(7):1021-1033. doi: 10.1002/eat.23287. Epub 2020 May 21.