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

June 7, 2021 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
After the 4-week intervention (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
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).
Baseline (T0) and after the 4-week intervention (T1)
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)
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)
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).
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)
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).
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)
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).
Baseline (T0) and after the 4-week intervention (T1)
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).
After the 4-week intervention (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jan Vagedes, ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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