Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial

Abstract Background Occupational stress is a major public health challenge that requires a variety of evidence-based preventative approaches to increase their reach within the working population. Behavioral stress management interventions are considered an established approach for occupational stres...

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Autores principales:	Leif Boß, Peter Angerer, Nico Dragano, David Ebert, Miriam Engels, Elena Heber, Rebekka Kuhlmann, Sascha Ruhle, Christian Schwens, Ines Catharina Wulf, Dirk Lehr
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Web-based intervention Stress management Occupational health E-mental health Randomized controlled trial Non-inferiority trial Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/c29e06f6585f4bfd8e1e495c4749508b
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spelling	oai:doaj.org-article:c29e06f6585f4bfd8e1e495c4749508b2021-11-28T12:12:40ZComparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial10.1186/s12889-021-12229-y1471-2458https://doaj.org/article/c29e06f6585f4bfd8e1e495c4749508b2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12889-021-12229-yhttps://doaj.org/toc/1471-2458Abstract Background Occupational stress is a major public health challenge that requires a variety of evidence-based preventative approaches to increase their reach within the working population. Behavioral stress management interventions are considered an established approach for occupational stress prevention. Both in-person group-based stress management training (gSMT) and individual Internet-based training (iSMT) have been shown to be effective at reducing stress in employees. However, there remains a lack of evidence on the comparative efficacy of the newer digital format compared to well-established, in-person, group-based training. This study aims (1) to directly compare an evidence-based iSMT with an established gSMT on stress in employees, (2) to analyze the two conditions from a cost perspective, and (3) to explore moderators of the comparative efficacy. Methods In a randomized, controlled, non-inferiority trial employees from the general working population will be allocated to iSMT or gSMT. The primary outcome will be perceived stress, assessed using the Perceived Stress Scale, three months after randomization. The non-inferiority margin for the primary outcome measure will be set at 2 points (Cohen’s d = 0.29). This trial will also compare the two interventions from a health economics perspective, and conduct explorative analyses to identify potential effect moderators. Discussion To reach a larger proportion of the working population, well-established gSMT should be complemented with interventions that fit today’s society’s increasingly digital lifestyle. The current trial will provide evidence supporting the responsible implementation of Internet-based stress management training if the digital format proves to at least be non-inferior to established group-based training. Additional explorative moderator analyses may guide future practices to aid in matching select programs with select users. Trial registration German Register of Clinical Studies (DRKS): DRKS00024892, date of registration: 2021-04-09. Protocol version: 02, 16-10-2021.Leif BoßPeter AngererNico DraganoDavid EbertMiriam EngelsElena HeberRebekka KuhlmannSascha RuhleChristian SchwensInes Catharina WulfDirk LehrBMCarticleWeb-based interventionStress managementOccupational healthE-mental healthRandomized controlled trialNon-inferiority trialPublic aspects of medicineRA1-1270ENBMC Public Health, Vol 21, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Web-based intervention Stress management Occupational health E-mental health Randomized controlled trial Non-inferiority trial Public aspects of medicine RA1-1270
spellingShingle	Web-based intervention Stress management Occupational health E-mental health Randomized controlled trial Non-inferiority trial Public aspects of medicine RA1-1270 Leif Boß Peter Angerer Nico Dragano David Ebert Miriam Engels Elena Heber Rebekka Kuhlmann Sascha Ruhle Christian Schwens Ines Catharina Wulf Dirk Lehr Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
description	Abstract Background Occupational stress is a major public health challenge that requires a variety of evidence-based preventative approaches to increase their reach within the working population. Behavioral stress management interventions are considered an established approach for occupational stress prevention. Both in-person group-based stress management training (gSMT) and individual Internet-based training (iSMT) have been shown to be effective at reducing stress in employees. However, there remains a lack of evidence on the comparative efficacy of the newer digital format compared to well-established, in-person, group-based training. This study aims (1) to directly compare an evidence-based iSMT with an established gSMT on stress in employees, (2) to analyze the two conditions from a cost perspective, and (3) to explore moderators of the comparative efficacy. Methods In a randomized, controlled, non-inferiority trial employees from the general working population will be allocated to iSMT or gSMT. The primary outcome will be perceived stress, assessed using the Perceived Stress Scale, three months after randomization. The non-inferiority margin for the primary outcome measure will be set at 2 points (Cohen’s d = 0.29). This trial will also compare the two interventions from a health economics perspective, and conduct explorative analyses to identify potential effect moderators. Discussion To reach a larger proportion of the working population, well-established gSMT should be complemented with interventions that fit today’s society’s increasingly digital lifestyle. The current trial will provide evidence supporting the responsible implementation of Internet-based stress management training if the digital format proves to at least be non-inferior to established group-based training. Additional explorative moderator analyses may guide future practices to aid in matching select programs with select users. Trial registration German Register of Clinical Studies (DRKS): DRKS00024892, date of registration: 2021-04-09. Protocol version: 02, 16-10-2021.
format	article
author	Leif Boß Peter Angerer Nico Dragano David Ebert Miriam Engels Elena Heber Rebekka Kuhlmann Sascha Ruhle Christian Schwens Ines Catharina Wulf Dirk Lehr
author_facet	Leif Boß Peter Angerer Nico Dragano David Ebert Miriam Engels Elena Heber Rebekka Kuhlmann Sascha Ruhle Christian Schwens Ines Catharina Wulf Dirk Lehr
author_sort	Leif Boß
title	Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
title_short	Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
title_full	Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
title_fullStr	Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
title_full_unstemmed	Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
title_sort	comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/c29e06f6585f4bfd8e1e495c4749508b
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Comparative effectiveness of guided internet-based stress management training versus established in-person group training in employees – study protocol for a pragmatic, randomized, non-inferiority trial

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