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

Abstract

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.

Internet-delivered cognitive behavioral interventions to reduce elevated stress: A systematic review and meta-analysis

“…Table 1 presents an overview of the trial characteristics of the 13 included studies. More than half of the trials were conducted in Germany ( Ebert et al, 2016a ; Ebert et al, 2016b ; Heber et al, 2016 ; Harrer and Adam, 2018 ; Jonas et al, 2016 ; Nixon et al, 2021 ; Mehring et al, 2016 ), two in Sweden ( Persson Asplund et al, 2018 ; Lindsäter et al, 2018 ), and one in Lithuania ( Eimontas et al, 2018 ), France ( Leterme et al, 2020 ), the United States ( Rose et al, 2013 ), and Spain ( Rachyla et al, 2018 ), respectively. Ten of 13 studies were conducted in a research setting, whereas three were conducted in healthcare settings such as online coaching service ( Jonas et al, 2016 ), psychiatric consultation service ( Leterme et al, 2020 ), and primary healthcare clinic ( Mehring et al, 2016 ).…”

“…Two studies used an attention control group, both consisting of an educational intervention giving participants information about stress, and one study compared ICBT to treatment as usual. In one study, participants were randomized to either adherence-guided ICBT, self-guided ICBT, or a waitlist control condition ( Nixon et al, 2021 ).…”

“…Three studies provided no follow-up data after post-intervention assessment ( Mehring et al, 2016 ; Eimontas et al, 2018 ; Rose et al, 2013 ). The remaining studies provided follow-up data after 3 months ( Harrer and Adam, 2018 ; Jonas et al, 2016 ; Rachyla et al, 2018 ) 6 months ( Leterme et al, 2020 ; Ebert et al, 2016a ; Ebert et al, 2016b ; Heber et al, 2016 ; Jonas et al, 2016 ; Nixon et al, 2021 ; Persson Asplund et al, 2018 ; Rachyla et al, 2018 ), 9 months ( Lindsäter et al, 2018 ), and 12 months ( Heber et al, 2016 ; Jonas et al, 2016 ; Rachyla et al, 2018 ) (from pre-assessment dates).…”

“…Two studies particularly targeted university students ( Harrer and Adam, 2018 ; Rose et al, 2013 ), and two studies recruited participants via clinical referral ( Leterme et al, 2020 ; Mehring et al, 2016 ). In recruiting participants, eight studies used a stress scale cut-off, of which six used versions of the Perceived Stress Scale ( Ebert et al, 2016a ; Ebert et al, 2016b ; Heber et al, 2016 ; Harrer and Adam, 2018 ; Nixon et al, 2021 ; Rose et al, 2013 ), one used the Maslach Burnout Inventory (MBI) ( Jonas et al, 2016 ), and one used the Brief Adjustment Disorder New Model (ADNM-8) questionnaire ( Eimontas et al, 2018 ). In five studies, clinical assessment was used for inclusion ( Leterme et al, 2020 ; Mehring et al, 2016 ; Persson Asplund et al, 2018 ; Lindsäter et al, 2018 ; Rachyla et al, 2018 ) of which all but one ( Mehring et al, 2016 ) assessed criteria for adjustment disorder or exhaustion disorder (both classified under F43 Reactions to severe stress, and adjustment disorders in the ICD).…”

Facilitating stress prevention in micro and small-sized enterprises: protocol for a mixed method study to evaluate the effectiveness and implementation process of targeted web-based interventions

“…The web-based training “GET.ON Stress” has already been evaluated showing significant effects on stress and stress-related problems like depressive symptoms as compared to controls [ 36 – 39 ]. It was designed to enhance two strategies of stress coping: problem-solving [ 40 ] and emotion regulation [ 41 ].…”