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NCT04921228
Biofeedback for CHAMPS
NA trial testing Heart rate variability biofeedback in Disordered Eating in 25 participants. Completed in 10 April 2022.
10 April 2022
Quick facts
| Lead sponsor | Villanova University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 8 November 2021 |
| Primary completion | 10 April 2022 |
| Estimated completion | 10 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Heart rate variability biofeedback — full drug profile →
Conditions studied
- Disordered Eating — all drugs for Disordered Eating →
- Stress — all drugs for Stress →
Sponsor
Villanova University
Who can join
18 and older, any sex, with Disordered Eating or Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Pilot Feasibility Evaluation of a Heart Rate Variability Biofeedback App to Improve Self-Care in COVID-19 Healthcare Workers.
Mensinger JL, Weissinger GM, Cantrell MA, Baskin R, et al · · 2024 · cited 6× · PMID 38502516 · DOI 10.1007/s10484-024-09621-w -
Interoceptive mechanisms of a mobile heart rate variability biofeedback app for eating disorder symptoms: Proof-of-concept findings.
Mensinger JL. · · 2026 · PMID 41319396 · DOI 10.1016/j.eatbeh.2025.102060 -
A Pilot Feasibility Evaluation of a Heart Rate Variability Biofeedback App to Improve Self-Care in COVID-19 Healthcare Workers
Mensinger JL, Weissinger GM, Cantrell MA, Baskin R, et al · · 2023 · DOI 10.21203/rs.3.rs-3446614/v1
Verify or expand the search:
- PubMed search for NCT04921228
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Heart rate variability biofeedback
Trials testing the same drug.
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- NCT05922059 — Effects of Autonomic Nervous System Modulation on Heart Rate Variability and Musculoskeletal Manifestations in Patients · NA · unknown
- NCT05687240 — Heart Focused Movement Effects on Cardiometabolic Risk · NA · completed
Other recruiting trials for Disordered Eating
Currently open trials in the same condition.
- NCT06807489 — Disordered Eating Risk in Pediatric Obesity Treatment Using a Digi-Physical Tool · active not recruiting
- NCT06226233 — Efficacy of Juniver, a Digital Self-help Intervention, on Symptoms of Eating Disorders: A Randomised Controlled Trial · NA · active not recruiting
- NCT05744232 — ARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing · NA · active not recruiting
Other Villanova University trials
Trials by the same sponsor.
- NCT07415850 — The Effect of a Four-Week Hatha Yoga Intervention to Improve Quality of Life, Anxiety, and Depressive Symptoms in Indivi · NA · not yet recruiting
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- NCT06565429 — Feasibility of the 5-Step Method in the U.S. · NA · recruiting
- NCT05674110 — Screening and Nutrition for Patients With Diabetes: A Pilot Study · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04921228 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Villanova University
- Last refreshed: 28 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04921228.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing