Clinical trial NCT04897165: 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
Overall status: COMPLETED
Phase: NA
Conditions: Work-Related Stress
Burnout
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: COPSOQ personal burnout after the intervention
timeFrame: After the 4-week intervention (T1)
Secondary outcomes:
measure: Change in the COPSOQ scale personal burnout between baseline (T0) and 4-week follow-up (T2)
timeFrame: Baseline (T0) and 4-week follow-up (T2)
measure: Change in the COPSOQ scale subjective general health between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
timeFrame: Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
measure: Change in the COPSOQ scale work-privacy conflict between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
timeFrame: Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
measure: Change in the COPSOQ scale behavioral stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
timeFrame: Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
measure: Change in the COPSOQ scale cognitive stress symptoms between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
timeFrame: Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
measure: Change in self-reported sleep quality between baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
timeFrame: Baseline (T0), after the 4-week intervention (T1), and 4-week follow-up (T2)
measure: HRV analysis: Change in SDNN between baseline (T0) and after the 4-week intervention (T1)
timeFrame: Baseline (T0) and after the 4-week intervention (T1)
measure: HRV analysis: Change in RMSSD between baseline (T0) and after the 4-week intervention (T1)
timeFrame: 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).
measure: HRV analysis: Change in pNN50 between baseline (T0) and after the 4-week intervention (T1)
timeFrame: Baseline (T0) and after the 4-week intervention (T1)
measure: HRV analysis: Change in Baevsky's stress index between baseline (T0) and after the 4-week intervention (T1)
timeFrame: Baseline (T0) and after the 4-week intervention (T1)
measure: HRV analysis: Change in the degree of rhythmization between baseline (T0) and after the 4-week intervention (T1)
timeFrame: Baseline (T0) and after the 4-week intervention (T1)
measure: Training evaluation
timeFrame: After the 4-week intervention (T1)
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute Academic Research in Complementary and Integrative Medicine
name: Jan Vagedes
role: STUDY_DIRECTOR
References: