Work-Related StressNCT04897165
Resilience Training for Work-related Stress in Employees and the Influence of the Lecture Format on Training Success
A study testing Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures) and Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures) in people with Work-Related Stress and Burnout, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-Related Stress, Burnout
- What is being tested?
- Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures) and Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 4 Oct 2016to 19 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Employees of the company at which the study is conducted
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Work-Related Stress, Burnout
- Being tested
- 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)
- Medical subject headings
- Occupational Stress, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures) | Experimental | Not described Receives: 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 | Not described Receives: Other: Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures) |
| Waitlist controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: After the 4-week intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start4 Oct 2016
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-Related StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Study director, ARCIM Institute Academic Research in Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897165
- Sponsor's protocol ID
- STM_05
- Status last verified
- Jun 2021
- First submitted
- 18 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Publications
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.
PubMed 39485585
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04897165
- Acronym / sponsor ID
- STM_05
- Conditions
- Work-Related Stress, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Employees of the company at which the study is conducted
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | 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)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. | Other | Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures) |
Primary outcome
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).
12 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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).
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)
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)
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)
Training evaluation
Time frame: After the 4-week intervention (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 39485585Vagedes 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes study director
ARCIM Institute Academic Research in Complementary and Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures) and Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures) in people with Work-Related Stress and Burnout, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPSOQ personal burnout after the intervention (time frame: After the 4-week intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.