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

BMC Public Health

Rebekka Kuhlmann¹  Sascha Ruhle¹  Leif Boß²  Dirk Lehr²  David Ebert³  Christian Schwens⁴  Elena Heber⁵  Nico Dragano⁶  Ines Catharina Wulf⁶  Miriam Engels⁶  Peter Angerer⁷ 

[1]Chair of Business Administration, in particular Work, Human Resource Management and Organization Studies, Faculty of Business Administration and Economics, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

[2]Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University Lüneburg, Lüneburg, Germany

[3]Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany

[4]Endowed Chair for Interdisciplinary Management Science, School of Management, Economics and Social Sciences, University of Cologne, Cologne, Germany

[5]GET.ON Institut für Online Gesundheitstrainings GmbH, Hamburg, Germany

[6]Institute of Medical Sociology, Centre for Health and Society, Medical Faculty and University Hospital, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

[7]Institute of Occupational, Social and Environmental Medicine, Centre for Health and Society, Medical Faculty and University Hospital, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

关键词: Web-based intervention;    Stress management;    Occupational health;    E-mental health;    Randomized controlled trial;    Non-inferiority trial;   

DOI  :  10.1186/s12889-021-12229-y

来源: Springer

【 摘 要 】

BackgroundOccupational 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.MethodsIn 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.DiscussionTo 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 registrationGerman Register of Clinical Studies (DRKS): DRKS00024892, date of registration: 2021-04-09.Protocol version: 02, 16-10-2021.

【 授权许可】

CC BY