Resilience Training for Work-related Stress in Employees and the Influence of the Lecture Format on Training Success

NCT04897165 | Completed

• 1 other identifier: STM_05
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A study to analyze the psychophysiological effects of a preventative, 4-week resilience training with mobile heart rate variability biofeedback (HRV-BfB) in a workplace setting and the influence of the lecture format (digital vs. live) on the training success.

Conditions

Work-Related Stress; Burnout

Outcome Measures

Primary Outcomes (1)

• COPSOQ personal burnout after the intervention

  Personal burnout was assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T1. Six questions were answered on an ordinal scale, transformed to values ranging between 0=minimum value and 100=maximum value (higher values indicate a more severe burnout symptomatology) and averaged to obtain a scale score (0-100).

  After the 4-week intervention (T1)

Secondary Outcomes (12)

• Change in the COPSOQ scale personal burnout between baseline (T0) and 4-week follow-up (T2)

  Baseline (T0) and 4-week follow-up (T2)

• Change in the COPSOQ scale subjective general health between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

  Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

• Change in the COPSOQ scale work-privacy conflict between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

  Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

• Change in the COPSOQ scale behavioral stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

  Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

• Change in the COPSOQ scale cognitive stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

  Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

Study Arms (3)

Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)

EXPERIMENTAL

Other: Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)

Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)

EXPERIMENTAL

Other: Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)

Waitlist controls

NO INTERVENTION

Interventions

Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures) OTHER

A 4-week resilience training with a mobile HRV-BfB device. Participants received access to three online lectures at the start of the first, third, and forth training week (each lasting 60 minutes) to receive a theoretical base on resilience and to learn how to exercise with the HRV-BfB device. Participants were asked to exercise three times a day for 5 minutes in their occupational and leisure time with the HRV-BfB device.

Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)

Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures) OTHER

A 4-week resilience training with a mobile HRV-BfB device. Participants attended three live lectures at the start of the first, third, and forth training week (each lasting 90 minutes) to receive a theoretical base on resilience and to learn how to exercise with the HRV-BfB device. Participants were asked to exercise three times a day for 5 minutes in their occupational and leisure time with the HRV-BfB device.

Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Employees of the company at which the study is conducted

You may not qualify if:

• Implanted pacemaker
• Medically diagnosed heart failure or arrhythmia
• Medically prescribed cardiac drugs (e.g., beta-blockers, diuretics, ACE inhibitors, calcium channel blockers, or antiarrhythmic agents)

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Related Publications (1)

• Vagedes J, Szoke H, Islam MOA, Sobh M, Kuderer S, Khazan I, Vagedes K. Mobile Heart Rate Variability Biofeedback for Work-Related Stress in Employees and the Influence of Instruction Format (Digital or Live) on Training Outcome: A Non-Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2025 Mar;50(1):79-93. doi: 10.1007/s10484-024-09671-0. Epub 2024 Nov 1.

  PMID: 39485585 DERIVED

MeSH Terms

Conditions

Occupational Stress; Burnout, Psychological

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jan Vagedes

  ARCIM Institute Academic Research in Complementary and Integrative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: October 4, 2016
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)