TY - JOUR

T1 - A three-armed randomised controlled trial investigating the comparative impact of guidance on the efficacy of a web-based stress management intervention and health impairing and promoting mechanisms of prevention

AU - Nixon, Patricia

AU - Boß, Leif

AU - Heber, Elena

AU - Ebert, David Daniel

AU - Lehr, Dirk

N1 - This publication was funded by the Open Access Publication Fund of Leuphana University Lüneburg. This study is funded by the European Union (EFRE: ZW6–80119999, CCI 2007DE161PR001) and the BARMER GEK. Open Access funding enabled and organized by Projekt DEAL.

PY - 2021/12/1

Y1 - 2021/12/1

N2 - Background: Web-based stress management interventions (SMI) fit increasingly digital lifestyles, reduce barriers of uptake and are easily scalable. SMIs might lower levels of stress in employees and thereby contribute to the prevention of depressive symptomatology. Different guidance formats can impact the efficacy of SMIs, with higher intensity assumed to result in larger effects. However, head-to-head comparisons of guidance formats are rare. This is the first trial to examine the impact of adherence-focused guidance compared to self-help on the efficacy of an occupational SMI compared to a wait list control condition. Additionally, it will be investigated if the SMI enfolds its impact on preventing depressive symptomatology by different pathways through reducing health impairing and increasing promoting factors. Methods: A three-armed randomised controlled trial (RCT) on an occupational SMI was conducted. 404 employees with elevated levels of perceived stress (PSS-10 ≥ 22) were randomly assigned to: adherence-focused guidance (AFG), self-help (SH) or a wait list control group (WLC). The primary outcome was perceived stress (PSS-10). Secondary outcomes included health- and work-related measures. A parallel mediation analysis with stress and resilience as mediators for the effect on depression (CES-D) was carried out. Data collection took place at baseline (T1), after 7 weeks (T2) and 6 months (T3). Results: The SMI was effective for all groups on the primary and secondary outcomes. For stress, analyses of covariance (ANCOVA) revealed significant group effects at T2 (F2,400 = 36.08, P <.001) and T3 (F2,400 = 37.04, P <.001) with large effect sizes for AFG (T2: d = 0.83; T3: d = 0.85) and SH (T2: d = 0.88; T3: d = 0.91) compared to WLC. No significant group differences were found for the efficacy between AFG and SH on the outcomes. Adherence in terms of completed modules was significantly higher for AFG compared to SH. The SMI’s impact on depression was mediated by perceived stress: a1b1 = − 0.77, 95% CI [− 1.26, − 0.34] and resilience: a2b2 = − 0.62, 95% CI [− 1.05, − 0.26]. Conclusions: The SMI was effective for reducing stress and improving other health- and work-related outcomes, irrespective of the guidance format. Results did not demonstrate superiority of adherence-focused guidance for the efficacy but for adherence in terms of completed modules. Among other reasons, better communication strategies about offered guidance and awareness-raising measures are discussed. Results from mediation analysis suggest that preventive SMIs should be designed to reach two goals: reducing the risk factor of stress and simultaneously increasing health promoting factors such as resilience. Trial registration: German Clinical Trial Registration (DRKS) DRKS00005687, 6/6/2014.

AB - Background: Web-based stress management interventions (SMI) fit increasingly digital lifestyles, reduce barriers of uptake and are easily scalable. SMIs might lower levels of stress in employees and thereby contribute to the prevention of depressive symptomatology. Different guidance formats can impact the efficacy of SMIs, with higher intensity assumed to result in larger effects. However, head-to-head comparisons of guidance formats are rare. This is the first trial to examine the impact of adherence-focused guidance compared to self-help on the efficacy of an occupational SMI compared to a wait list control condition. Additionally, it will be investigated if the SMI enfolds its impact on preventing depressive symptomatology by different pathways through reducing health impairing and increasing promoting factors. Methods: A three-armed randomised controlled trial (RCT) on an occupational SMI was conducted. 404 employees with elevated levels of perceived stress (PSS-10 ≥ 22) were randomly assigned to: adherence-focused guidance (AFG), self-help (SH) or a wait list control group (WLC). The primary outcome was perceived stress (PSS-10). Secondary outcomes included health- and work-related measures. A parallel mediation analysis with stress and resilience as mediators for the effect on depression (CES-D) was carried out. Data collection took place at baseline (T1), after 7 weeks (T2) and 6 months (T3). Results: The SMI was effective for all groups on the primary and secondary outcomes. For stress, analyses of covariance (ANCOVA) revealed significant group effects at T2 (F2,400 = 36.08, P <.001) and T3 (F2,400 = 37.04, P <.001) with large effect sizes for AFG (T2: d = 0.83; T3: d = 0.85) and SH (T2: d = 0.88; T3: d = 0.91) compared to WLC. No significant group differences were found for the efficacy between AFG and SH on the outcomes. Adherence in terms of completed modules was significantly higher for AFG compared to SH. The SMI’s impact on depression was mediated by perceived stress: a1b1 = − 0.77, 95% CI [− 1.26, − 0.34] and resilience: a2b2 = − 0.62, 95% CI [− 1.05, − 0.26]. Conclusions: The SMI was effective for reducing stress and improving other health- and work-related outcomes, irrespective of the guidance format. Results did not demonstrate superiority of adherence-focused guidance for the efficacy but for adherence in terms of completed modules. Among other reasons, better communication strategies about offered guidance and awareness-raising measures are discussed. Results from mediation analysis suggest that preventive SMIs should be designed to reach two goals: reducing the risk factor of stress and simultaneously increasing health promoting factors such as resilience. Trial registration: German Clinical Trial Registration (DRKS) DRKS00005687, 6/6/2014.

KW - Occupational health

KW - Randomised controlled trial

KW - Stress management

KW - Web-based

KW - Health sciences

KW - Psychology

UR - http://www.scopus.com/inward/record.url?scp=85112674619&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/e6d15943-0c31-3bde-8b8e-49e02cc4196f/

U2 - 10.1186/s12889-021-11504-2

DO - 10.1186/s12889-021-11504-2

M3 - Journal articles

C2 - 34353294

AN - SCOPUS:85112674619

VL - 21

JO - BMC Public Health

JF - BMC Public Health

SN - 1471-2458

IS - 1

M1 - 1511

ER -