TY - JOUR

T1 - 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

AU - Boß, Leif

AU - Angerer, Peter

AU - Dragano, Nico

AU - Ebert, David

AU - Engels, Miriam

AU - Heber, Elena

AU - Kuhlmann, Rebekka

AU - Ruhle, Sascha

AU - Schwens, Christian

AU - Wulf, Ines Catharina

AU - Lehr, Dirk

N1 - Open Access funding enabled and organized by Projekt DEAL. This study is funded by the German Federal Ministry of Education and Research (BMBF) within the Framework Concept „Future of work “(fund number 02L16D020 to 02L16D023) and managed by the Project Management Agency Forschungszentrum Karlsruhe, Production and Manufacturing Technologies Division (PTKA). The funder is not involved in the design of the study, collection, analysis, interpretation of data, or in writing the manuscript.

PY - 2021/12/1

Y1 - 2021/12/1

N2 - 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.

AB - 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.

KW - E-mental health

KW - Non-inferiority trial

KW - Occupational health

KW - Randomized controlled trial

KW - Stress management

KW - Web-based intervention

KW - Health sciences

KW - Psychology

UR - http://www.scopus.com/inward/record.url?scp=85120050309&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/8eb7d572-0e7e-31de-ba0a-74027b1f2cd0/

U2 - 10.1186/s12889-021-12229-y

DO - 10.1186/s12889-021-12229-y

M3 - Journal articles

C2 - 34837999

AN - SCOPUS:85120050309

VL - 21

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

IS - 1

M1 - 2177

ER -