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Completed

NCT Number: NCT04897165

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

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Key information

Conditions

Work-Related Stress Behavior Behavioral Symptoms Burnout Burnout, Psychological Occupational Diseases Occupational Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 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.

Primary outcomes

  1. COPSOQ personal burnout after the intervention

    Time frame: After the 4-week intervention (T1)

    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 outcomes

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

  6. Change in self-reported sleep quality between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)

    Time frame: 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).

  7. HRV analysis: Change in SDNN between baseline (T0) and after the 4-week intervention (T1)

    Time frame: 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).

  8. HRV analysis: Change in RMSSD between 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).

    Baseline (T0) and after the 4-week intervention (T1)

  9. HRV analysis: Change in pNN50 between baseline (T0) and after the 4-week intervention (T1)

    Time frame: 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).

  10. HRV analysis: Change in Baevsky's stress index between baseline (T0) and after the 4-week intervention (T1)

    Time frame: 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).

  11. HRV analysis: Change in the degree of rhythmization between baseline (T0) and after the 4-week intervention (T1)

    Time frame: 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).

  12. Training evaluation

    Time frame: After the 4-week intervention (T1)

    Participants rated the training success, integrability and the responding to questions and needs on a 5-point scale (1=positive, 5=negative).

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 21, 2021
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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