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

NCT ID: NCT04897165

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-04

Study Completion Date

2016-12-19

Brief Summary

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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

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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

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Work-Related Stress Burnout

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)

Group Type EXPERIMENTAL

Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)

Intervention Type 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)

Group Type EXPERIMENTAL

Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)

Intervention Type 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.

Waitlist controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes

Role: STUDY_DIRECTOR

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Locations

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Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39485585 (View on PubMed)

Other Identifiers

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STM_05

Identifier Type: -

Identifier Source: org_study_id

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