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Open Access 01-12-2019 | Care | Study protocol

Cluster-randomised trial evaluating a complex intervention to improve mental health and well-being of employees working in hospital – a protocol for the SEEGEN trial

Authors: Nadine Mulfinger, Anja Sander, Felicitas Stuber, Regina Brinster, Florian Junne, Ronald Limprecht, Marc N. Jarczok, Tanja Seifried-Dübon, Monika A. Rieger, Stephan Zipfel, Martin Peters, Maja Stiawa, Imad Maatouk, Madeleine Helaß, Christoph Nikendei, Eva Rothermund, Nicole Hander, Ute Ziegenhain, Manuela Gulde, Melanie Genrich, Britta Worringer, Janna Küllenberg, Karl Blum, Stefan Süß, Elena Gesang, Sascha Ruhle, Andreas Müller, Jochen Schweitzer-Rothers, Peter Angerer, Harald Gündel, Contributors of the SEEGEN consortium

Published in: BMC Public Health | Issue 1/2019

Abstract

Background

Health care employees in Germany and worldwide are exposed to a variety of stressors. However, most of the hospitals in Germany lack a systematic workplace health management. Thus, this study aims at the evaluation of the effects of a behavioural as well as organisational (´complex´) intervention on the mental health and well-being of hospital staff.

Methods

Mental health in the hospital workplace (SEElische GEsundheit am Arbeitsplatz KrankeNhaus – SEEGEN) is an unblinded, multi-centred cluster-randomised open trial with two groups (intervention group (IG) and waitlist control group (CG)). Study participants in the intervention clusters will receive the complex intervention; study participants in the waitlist control clusters will receive the complex intervention after the last follow-up measurement. The intervention consists of five behavioural and organisational intervention modules that are specifically tailored to hospital employees at different hierarchical and functional levels. Hospital staff may select one specific module according to their position and specific needs or interests. Towards the end of the intervention roundtable discussions with representatives from all professional groups will be held to facilitate organisational change. Primary outcome is the change in emotional and cognitive strain in the working environment, from baseline (T0) to 6 month-follow up (T1), between IG and CG. In addition, employees who do not participate in the modules are included in the trial by answering shorter questionnaires (cluster participants). Furthermore, using mixed methods, a process evaluation will identify uptake of the intervention, and mediators and moderators of the effect.

Discussion

There seems to be growing psychological strain on people working in the health care sector worldwide. This study will examine whether investing directly in the hospital staff and their interpersonal relationship may lead to measurable benefits in subjective well-being at the workplace and improved economic performance indicators of the hospital. In case of a positive outcome, health promotion strategies looking at behavioural as well as organisational components within the hospital may gain additional importance, especially in regard of the growing financial pressure within the health sector.

Trial registration DRKS

The SEEGEN study is registered at the German Clinical Trial Register (DRKS) under the DRKS-ID DRKS00017249. Registered 08 October 2019, URL.

https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017249.

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Title: Cluster-randomised trial evaluating a complex intervention to improve mental health and well-being of employees working in hospital – a protocol for the SEEGEN trial
Authors: Nadine Mulfinger
Anja Sander
Felicitas Stuber
Regina Brinster
Florian Junne
Ronald Limprecht
Marc N. Jarczok
Tanja Seifried-Dübon
Monika A. Rieger
Stephan Zipfel
Martin Peters
Maja Stiawa
Imad Maatouk
Madeleine Helaß
Christoph Nikendei
Eva Rothermund
Nicole Hander
Ute Ziegenhain
Manuela Gulde
Melanie Genrich
Britta Worringer
Janna Küllenberg
Karl Blum
Stefan Süß
Elena Gesang
Sascha Ruhle
Andreas Müller
Jochen Schweitzer-Rothers
Peter Angerer
Harald Gündel
Contributors of the SEEGEN consortium
Publication date: 01-12-2019
Publisher: BioMed Central
Keyword: Care
Published in: BMC Public Health / Issue 1/2019
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/s12889-019-7909-4

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Cluster-randomised trial evaluating a complex intervention to improve mental health and well-being of employees working in hospital – a protocol for the SEEGEN trial

Abstract

Background

Methods

Discussion

Trial registration DRKS

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration DRKS

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