CompletedNot Applicable

Biofeedback for CHAMPS

United States25 participantsStarted 2021-11-08

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre-enrollment:

Timeframe: Consent interview/Baseline assessment - Week 0

Full enrollment:

Timeframe: Participant receipt of study device and initial study visit - Week 2

Engagement/adherence to protocol

Timeframe: Begins as soon the participant begins biofeedback training through the end of HRV biofeedback intervention - 8 weeks total

Attrition/Drop out

Timeframe: Training visit through final check-in and post-intervention assessments (approximately 10 weeks of study involvement

Usability

Timeframe: post-intervention assessment (approximately 8 weeks after HRV biofeedback training visit)

Trial details

NCT IDNCT04921228

SponsorVillanova University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-10

View on ClinicalTrials.gov More Disordered Eating trials