Disordered EatingNCT04921228
Biofeedback for CHAMPS
A study testing Heart rate variability biofeedback in people with Disordered Eating and Stress, run by Villanova University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disordered Eating, Stress
- What is being tested?
- Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Use of illicit stimulants (e.g., cocaine) or narcotic drugs
- Inability to perform study protocol (self selected)
- Current use of HRV biofeedback training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Variability Biofeedback in Healthcare Providers During COVID-19: A Pilot Feasibility Study
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).
Read the 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:
- assess the feasibility of implementing a digitally based HRV biofeedback protocol
- assess the acceptability and usability of HRV biofeedback in healthcare providers with elevated disordered eating
- examine signals of efficacy to begin building a conceptual model of the potential mechanisms underlying change in outcomes
- 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.
- Conditions
- Disordered Eating, Stress
- Being tested
- Heart rate variability biofeedback
- 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
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-intervention assessment (approximately 8 weeks after HRV biofeedback training visit)
Secondary outcomes (9)
Variation in disordered eating attitudes and behaviors
Measured using the Eating Disorder Examination-Questionnaire 7-itemBrief, (EDE-Q7 Range: 0-6, higher scores indicate worse outcome)
Measured: 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
Measured using the Loss of Control Eating Scale-7 item Brief (LOCES-Brief Range: 1-5, higher scores indicate worse outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
Variation in perceived stress
Measured using the Perceived Stress Scale, (PSS Range: 0-40, higher scores indicate worse outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in mindful self-care
Measured using the Mindful Self-Care Scale, (MSCS Range: depends on dimension, higher scores indicate better outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in interoception
Measured using the Multidimensional Assessment of Interoceptive Awareness - Version 2, (MAIA-v2 Range: 0-5, higher scores indicate better outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in interoception
Measured using the Hunger and Satiety subscale of the Intuitive Eating Scale-2 (IES-2 Range: 1-5, higher scores indicate better outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in body appreciation
Measured using the Body Appreciation Scale-2 (BAS-2 Range: 1-5, higher scores indicate better outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in resilience
Measured using the Sense of Coherence Scale Revised (SOC-R Range: depends on dimension, higher scores indicate better outcome)
Measured: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in HRV
Measured using the average daily RMSSD pre and post HRV biofeedback training
Measured: baseline, post intervention (approximately 10 weeks after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start8 Nov 2021
- Primary completion10 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disordered EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janell Mensinger, PhD, Principal investigator, Villanova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921228
- Sponsor's protocol ID
- IRB-FY2021-233
- Status last verified
- Jun 2022
- First submitted
- 20 May 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with investigators who contact the PI after establishing terms of use and collaborative agreement
Publications
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.
PubMed 32385728Martin 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.
PubMed 31454626Pinna 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.
PubMed 32849058Watford 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.
PubMed 32437089Mensinger 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.
PubMed 38502516
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Biofeedback in Healthcare Providers During COVID-19: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04921228
- Acronym / sponsor ID
- IRB-FY2021-233
- Conditions
- Disordered Eating, Stress
- Keywords
- Heart rate variability biofeedback, Disordered eating, Eating Disorders, Perceived Stress, Interoception, Interoceptive awareness, Vagal tone, Mind-body approaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess the feasibility of implementing a digitally based HRV biofeedback protocol
- assess the acceptability and usability of HRV biofeedback in healthcare providers with elevated disordered eating
- examine signals of efficacy to begin building a conceptual model of the potential mechanisms underlying change in outcomes
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability biofeedback | Experimental | Behavioral: Heart rate variability biofeedbackHeart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- History of a heart transplant or a pacemaker.
- Uncontrolled kidney disease
- Uncontrolled diabetes
- Heart failure
- COPD (Chronic Obstructive Pulmonary Disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Heart rate variability biofeedback |
Primary outcome
Pre-enrollment:
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.
Full enrollment:
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.
Engagement/adherence to protocol
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.
Attrition/Drop out
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.
Usability
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.
9 secondary outcomes
Variation in disordered eating attitudes and behaviors
Time frame: 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
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit
Variation in perceived stress
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in mindful self-care
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in interoception
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in interoception
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in body appreciation
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in resilience
Time frame: baseline, midpoint (1 month after HRV biofeedback training visit), post intervention (2 months after HRV biofeedback training visit)
Variation in HRV
Time frame: baseline, post intervention (approximately 10 weeks after baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Background: PubMed 32385728Lehrer 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.
- Background: PubMed 31454626Martin 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.
- Background: PubMed 32849058Pinna 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.
- Background: PubMed 32437089Watford 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.
- Derived from this study: PubMed 38502516Mensinger 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.
- Individual participant dataSharing planned: Yes. Data will be shared with investigators who contact the PI after establishing terms of use and collaborative agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janell Mensinger, PhD principal investigator
Villanova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback in people with Disordered Eating and Stress, run by Villanova University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-enrollment: (time frame: Consent interview/Baseline assessment - Week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921228, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.