Biofeedback for CHAMPS

NCT04921228 | Completed

• 1 other identifier: IRB-FY2021-233
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (5)

• Pre-enrollment:

  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.

  Consent interview/Baseline assessment - Week 0

• Full enrollment:

  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.

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

• Engagement/adherence to protocol

  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.

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

• Attrition/Drop out

  Measured by calculating the proportion of fully enrolled participants who complete the pilot study. This is to assess feasibility of program implementation.

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

• Usability

  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.

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

Secondary Outcomes (9)

• Variation in disordered eating attitudes and behaviors

  baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit

• Variation in disordered eating attitudes and behaviors

  baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit

• Variation in perceived stress

  baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)

• Variation in mindful self-care

  baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)

• Variation in interoception

  baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)

Study Arms (1)

Heart rate variability biofeedback

EXPERIMENTAL

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.

Behavioral: Heart rate variability biofeedback

Interventions

Heart rate variability biofeedback BEHAVIORAL

* 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

Heart rate variability biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Villanova University: lead

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085, United States

Location

Related Publications (5)

• 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.

  PMID: 32385728 BACKGROUND

• 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.

  PMID: 31454626 BACKGROUND

• 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.

  PMID: 32849058 BACKGROUND

• 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.

  PMID: 32437089 BACKGROUND

• Mensinger JL, Weissinger GM, Cantrell MA, Baskin R, George C. A Pilot Feasibility Evaluation of a Heart Rate Variability Biofeedback App to Improve Self-Care in COVID-19 Healthcare Workers. Appl Psychophysiol Biofeedback. 2024 Jun;49(2):241-259. doi: 10.1007/s10484-024-09621-w.

  PMID: 38502516 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Janell Mensinger, PhD

  Villanova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 10, 2021
• Study Start: November 8, 2021
• Primary Completion: April 10, 2022
• Study Completion: April 10, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When available

Locations

US (1)