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

Resilience Training With Mobile Heart Rate Variability Biofeedback for Work-related Stress in White-collar Employees and the Influence of the Lecture Format (Digital vs. Live) on Training Success

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.

Study Overview

• Status: Completed
• Conditions: Burnout; Work-Related Stress
• Intervention / Treatment: Other: Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures); Other: Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)

Detailed Description

This was a three-arm, non-randomized, controlled trial to examine the effects of a preventative, 4-week resilience training with mobile HRV-BfB on work-related stress in white-collar employees. Participants were asked to exercise autonomously three times per day for five minutes with the mobile HRV-BfB device. They additionally attended three lectures at the beginning of the first, third, and forth week. The aim of the lectures was to mediate a theoretical knowledge and to prepare the participants for the autonomous training. To examine the potential influence of the lecture format, one group attended live lectures (blended learning condition) and one group received access to online lectures (e-learning condition). Results of study's outcome measures were compared with a waitlist control group. Outcome measures were assessed at baseline (T0), after the 4-week intervention (T1), and at 4-week follow-up (T2).

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)	Other: Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures); 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.
Experimental: Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)	Other: Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures); 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.
No Intervention: Waitlist controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the COPSOQ scale personal burnout between baseline (T0) and 4-week follow-up (T2)	Personal burnout was assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T0 and T2. 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).	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)	The subjective general health was assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ, originally derived from the EQ-5D) at T0, T1, and T2 (single question). The question was transformed to a scale ranging from 0=minimum value to 100=maximum value (lower values indicate a worse general health).	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)	Work-privacy conflict was assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T0 and T2. Five questions were answered on an ordinal scale, transformed to values ranging between 0=minimum value and 100=maximum value (higher values indicate a worse conflict) and averaged to obtain a scale score (0-100).	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)	Behavioral stress symptoms were assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T0 and T2. Eight questions were answered on an ordinal scale, transformed to values ranging between 0=minimum value and 100=maximum value (higher values indicate more severe stress symptoms) and averaged to obtain a scale score (0-100).	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)	Cognitive stress symptoms were assessed with the adapted German long version of the Copenhagen Psychosocial Questionnaire (COPSOQ) at T0 and T2. Four questions were answered on an ordinal scale, transformed to values ranging between 0=minimum value and 100=maximum value (higher values indicate more severe stress symptoms) and averaged to obtain a scale score (0-100).	Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Change in self-reported sleep quality between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)	Self-reported sleep quality, latency, and sleep duration were assessed with the Pittsburgh Sleep Quality Index (PSQI) at T0, T1, and T2. Items were averaged to obtain values between 0 and 3 (higher values indicate a poorer sleep).	Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
HRV analysis: Change in SDNN between baseline (T0) and after the 4-week intervention (T1)	Standard deviation of normal to normal (NN) intervals (ms). Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).	Baseline (T0) and after the 4-week intervention (T1)
HRV analysis: Change in RMSSD between baseline (T0) and after the 4-week intervention (T1)	Baseline (T0) and after the 4-week intervention (T1)	Root mean square of successive differences (ms). Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).
HRV analysis: Change in pNN50 between baseline (T0) and after the 4-week intervention (T1)	Percentage of successive NN intervals that differ from each other by more than 50 ms (%). Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).	Baseline (T0) and after the 4-week intervention (T1)
HRV analysis: Change in Baevsky's stress index between baseline (T0) and after the 4-week intervention (T1)	Baevsky's stress index is computed from the main characteristics of the inter-beat intervals histogram (mode value, mode amplitude, and variation range). Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).	Baseline (T0) and after the 4-week intervention (T1)
HRV analysis: Change in the degree of rhythmization between baseline (T0) and after the 4-week intervention (T1)	A measure that quantifies the respiratory sinus arrhythmia. Recorded with the software InnerBalanceTM Trainer (HeartMath Deutschland GmbH, Germany) and analyzed with the software HRV-Scanner (BioSign GmbH, Germany).	Baseline (T0) and after the 4-week intervention (T1)
Training evaluation	Participants rated the training success, integrability and the responding to questions and needs on a 5-point scale (1=positive, 5=negative).	After the 4-week intervention (T1)

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Study Director: Jan Vagedes, ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2016
• Primary Completion (Actual): December 19, 2016
• Study Completion (Actual): December 19, 2016

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: STM_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No