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Biofeedback for CHAMPS

NCT04921228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-06-28

No results posted yet for this study

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).

Conditions

  • Disordered Eating
  • Stress

Interventions

BEHAVIORAL

Heart rate variability biofeedback

* 5 days of 3-min HRV readings to establish baseline HRV * After meeting with study personnel to review HRV biofeedback (BF) practice with the app, participants will be asked to begin HRV BF training for 5 min a day * Participants will increase the length of HRV BF training by 5 min every few days until they reach 20 min a day of HRV BF training * Participants will aim for 20 min of daily HRV BF training for 6 consecutive wks out of the 8-wk total BF training protocol * Study personnel will follow the participants' progress with training via the online portal provided through the Optimal HRV app and have brief (15-min) check-in appts. with participants to discuss how they are experiencing HRV BF, what they find helpful, and barriers to their practice if they are having difficulties * After completing the 8-wks of BF training (including 2 wks of 5-min titrations to the full 20-min protocol), participants will be asked to take 3-min HRV readings for 5 days to assess post-intervention HRV

Sponsors & Collaborators

  • Villanova University

    lead OTHER

Principal Investigators

  • Janell Mensinger, PhD · Villanova University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-04-10
Completion
2022-04-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921228 on ClinicalTrials.gov