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

Primary Purpose

Work-Related Stress, Burnout

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
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)
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Work-Related Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Arcim Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

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)

Waitlist controls

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
HRV analysis: Change in RMSSD between baseline (T0) and after the 4-week intervention (T1)
Baseline (T0) and after the 4-week intervention (T1)
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).
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).
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).
Training evaluation
Participants rated the training success, integrability and the responding to questions and needs on a 5-point scale (1=positive, 5=negative).

Full Information

First Posted
May 18, 2021
Last Updated
June 7, 2021
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04897165
Brief Title
Resilience Training for Work-related Stress in Employees and the Influence of the Lecture Format on Training Success
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work-Related Stress, Burnout

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)
Arm Type
Experimental
Arm Title
Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)
Arm Type
Experimental
Arm Title
Waitlist controls
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)
Intervention Description
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.
Primary Outcome Measure Information:
Title
COPSOQ personal burnout after the intervention
Description
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).
Time Frame
After the 4-week intervention (T1)
Secondary Outcome Measure Information:
Title
Change in the COPSOQ scale personal burnout between baseline (T0) and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0) and 4-week follow-up (T2)
Title
Change in the COPSOQ scale subjective general health between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Title
Change in the COPSOQ scale work-privacy conflict between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Title
Change in the COPSOQ scale behavioral stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Title
Change in the COPSOQ scale cognitive stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Title
Change in self-reported sleep quality between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Description
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).
Time Frame
Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
Title
HRV analysis: Change in SDNN between baseline (T0) and after the 4-week intervention (T1)
Description
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).
Time Frame
Baseline (T0) and after the 4-week intervention (T1)
Title
HRV analysis: Change in RMSSD between baseline (T0) and after the 4-week intervention (T1)
Description
Baseline (T0) and after the 4-week intervention (T1)
Time Frame
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).
Title
HRV analysis: Change in pNN50 between baseline (T0) and after the 4-week intervention (T1)
Description
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).
Time Frame
Baseline (T0) and after the 4-week intervention (T1)
Title
HRV analysis: Change in Baevsky's stress index between baseline (T0) and after the 4-week intervention (T1)
Description
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).
Time Frame
Baseline (T0) and after the 4-week intervention (T1)
Title
HRV analysis: Change in the degree of rhythmization between baseline (T0) and after the 4-week intervention (T1)
Description
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).
Time Frame
Baseline (T0) and after the 4-week intervention (T1)
Title
Training evaluation
Description
Participants rated the training success, integrability and the responding to questions and needs on a 5-point scale (1=positive, 5=negative).
Time Frame
After the 4-week intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Vagedes
Organizational Affiliation
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Arcim Institute
City
Filderstadt
State/Province
Baden-Württemberg
ZIP/Postal Code
70794
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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