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

BACKGROUND: Workplace-related stress is a major risk factor for mental and physical health problems and related sickness absence and productivity loss. Despite evidence regarding the effectiveness of different workplace-based interventions, the implementation of stress prevention interventions is rare, especially in micro and small-sized enterprises (MSE) with fewer than 50 employees. The joint research project “PragmatiKK”(+) aims to identify and address the specific barriers to the implementation of stress prevention interventions in MSE. This study protocol describes a mixed method study design to evaluate the effectiveness of adapted stress prevention interventions and the implementation process via an integrated web-based platform (“System P”) specifically targeted at MSE. METHODS: First, we develop a web-based intervention, which accounts for the specific working conditions in MSE and addresses stress prevention at a structural and behavioral level. Second, we use common methods of implementation research to perform an effect and process evaluation. We analyze the effectiveness of the web-based stress prevention interventions by comparing depressive symptoms at baseline and follow-up (after 6 months and 12 months). Indicators for a successful implementation process include acceptability, adoption, feasibility, reach, dose, and fidelity, which we will measure with quantitative web-based questionnaires and qualitative interviews. We will also analyze the accumulated usage data from the web-based platform. DISCUSSION: Collecting data on the implementation process and the effectiveness of a web-based intervention will help to identify and overcome common barriers to stress prevention in MSE. This can improve the mental health of employees in MSE, which constitute more than 90% of all enterprises in Germany. (+) Full Project Name: „PragmatiKK - Pragmatische Lösungen für die Implementation von Maßnahmen zur Stressprävention in Kleinst- und Kleinbetrieben “(= Pragmatic solutions for the implementation of stress prevention interventions in micro and small-sized enterprises). TRIAL REGISTRATION: German Register of Clinical Studies (DRKS): DRKS00026154, date of registration: 2021-09-16. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-022-12921-7

Efficacy of a web-based intervention with and without guidance for employees with risky drinking: results of a three-arm randomized controlled trial

AIMS: To test the efficacy of a web-based alcohol intervention with and without guidance. DESIGN: Three parallel groups with primary end-point after 6 weeks. SETTING: Open recruitment in the German working population. PARTICIPANTS: Adults (178 males/256 females, mean age 47 years) consuming at least 21/14 weekly standard units of alcohol (SUA) and scoring ≥ 8/6 on the Alcohol Use Disorders Identification Test. INTERVENTION: Five web-based modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation during 5 weeks. One intervention group received an unguided self-help version (n=146) and the second received additional adherence-focused guidance by eCoaches (n=144). Controls were on a waiting list with full access to usual care (n=144). MEASUREMENTS: Primary outcome was weekly consumed SUA after 6 weeks. SUA after 6 months was examined as secondary outcome, next to numbers of participants drinking within the low-risk range, and general and work-specific mental health measures. FINDINGS: All groups showed reductions of mean weekly SUA after 6 weeks (unguided: -8.0; guided: -8.5; control: -3.2). There was no significant difference between the unguided and guided intervention (P=0.324). Participants in the combined intervention group reported significantly fewer SUA than controls [B=-4.85, 95% confidence interval (CI)=-7.02 to -2.68, P < 0.001]. The intervention groups also showed significant reductions in SUA consumption after 6 months (B=-5.72, 95% CI=-7.71 to -3.73, P < 0.001) and improvements regarding general and work-related mental health outcomes after 6 weeks and 6 months. CONCLUSIONS: A web-based alcohol intervention, administered with or without personal guidance, significantly reduced mean weekly alcohol consumption and improved mental health and work-related outcomes in the German working population

The more I got, the less I need?: Efficacy of Internet-based guided self-help compared to online psychoeducation for major depressive disorder

BACKGROUND: This study's aims were to compare the efficacy and negative effects of guided Internet-based cognitive behavior therapy (iCBT) and online psychoeducation (OPE) in people with major depression. METHODS: A total of 131 individuals were randomized. Assessments took place at baseline (T1), six weeks (T2), and three months (T3). The primary endpoint was change in observer-based depression severity from T1 to T2. Potential negative effects were analyzed in terms of suicidal ideations, symptom deterioration, attitudes toward seeking further help, and other adverse events. RESULTS: iCBT (n = 65) and OPE (n = 66) both reduced depressive symptoms from T1 to T2, with large changes observed for iCBT and medium for OPE (iCBT: Cohen's d = 1.09; OPE: d = 0.60). Differences between groups were significant at the primary endpoint (d = 0.36, p = 0.028). OPE continued to have a positive effect from post-treatment to follow-up, while the effect of iCBT remained stable, with differences between groups not being significant anymore at follow-up. Participants who had undergone prior psychotherapy benefited from both treatments; but for those without prior psychotherapy, iCBT was superior also at follow-up. In the iCBT group 26.2% of the participants reported at least one side-effect. LIMITATIONS: The history of psychotherapy was imbalanced between the groups. Some negative effects were assessed in the iCBT group only. CONCLUSIONS: Both iCBT and OPE were effective in reducing depressive symptoms, but with iCBT having a more rapid effect. iCBT was specifically superior in those with no prior history of psychotherapy. Negative effects occurred frequently and should be considered when implementing iCBT. TRIAL REGISTRATION: German clinical trials register: DRKS00005025

The Efficacy of a Web-Based Stress Management Intervention for Employees Experiencing Adverse Working Conditions and Occupational Self-efficacy as a Mediator: Randomized Controlled Trial

BackgroundWork stress is highly prevalent and puts employees at risk for adverse health consequences. Web-based stress management interventions (SMIs) promoting occupational self-efficacy might be a feasible approach to aid employees to alleviate this burden and to enable them to improve an unbalanced situation between efforts and rewards at work. ObjectiveThe first aim of this randomized controlled trial was to investigate the efficacy of a web-based SMI for employees perceiving elevated stress levels and an effort-reward imbalance in comparison to a waitlist control (WLC) group. Second, we investigated whether the efficacy of an SMI could be explained by an increase in occupational self-efficacy and whether this personal resource enables employees to change adverse working conditions. MethodsA total of 262 employees reporting effort-reward imbalance scores over 0.715 and elevated stress levels (10-item Perceived Stress Scale [PSS-10] score ≥22) were randomly assigned to either the intervention group (IG; SMI) or the WLC group. The primary outcome was perceived stress measured using the PSS-10. The secondary outcomes included mental and work-related health measures. Four different mediation analyses were conducted with occupational self-efficacy, efforts, and rewards as mediators. After eligibility screening, data were collected web based at baseline (T1), 7 weeks (T2) and 6 months (T3). ResultsStudy participation was completed by 80% (105/130, 80.8%) in the IG and 90% (119/132, 90.2%) in the WLC group. Analyses of covariance revealed that stress reduction was significantly higher for the SMI group compared with the WLC group at T2 (d=0.87, 95% CI 0.61-1.12, P.05) while efforts still had a negative impact on stress (b=0.46, t257=2.32, P<.05). ConclusionsThe SMI was effective in reducing stress and improving occupational self-efficacy in employees despite them experiencing an effort-reward imbalance at work. Results from mediation analyses suggest that fostering personal resources such as occupational self-efficacy contributes to the efficacy of the SMI and enables employees to achieve positive changes regarding the rewarding aspects of the workplace. However, the SMI seemed to neither directly nor indirectly impact efforts, suggesting that person-focused interventions might not be sufficient and need to be complemented by organizational-focused interventions to comprehensively improve mental health in employees facing adverse working conditions. Trial RegistrationGerman Clinical Trials Register DRKS00005990; https://tinyurl.com/23fmzfu

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

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 &amp;gt;= 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 7weeks (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 (F-2,F-400=36.08, P&amp;lt;.001) and T3 (F-2,F-400=37.04, P&amp;lt;.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: a(1)b(1)=-0.77, 95% CI [-1.26, -0.34] and resilience: a(2)b(2)=-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

Feasibility and efficacy of a digital resilience training: A pilot study of the strengths-based training RESIST

Background: Work-related stress is a risk factor for a number of adverse health and work outcomes. Resilience trainings are a promising approach for adequately dealing with work stress and keeping employees mentally healthy. However, results of previous resilience trainings have been heterogeneous, ranging from null findings to large effects. Existing digital resilience interventions show a lack of consistency in terms of an underlying theoretical framework and methods used to foster resilience. Positive Appraisal Style Theory of Resilience offers an innovative conceptualization of resilience. Strengths-based cognitive behavioral therapy is a corresponding therapeutically method reflecting resilience as a resource-oriented process of dealing with stress. Based on this background, a new hybrid web-and app-based digital resilience intervention for employees named RESIST was developed. Objective: The first aim of the study was to investigate the feasibility of the newly developed training RESIST regarding its usability, user behavior, user experience and motivation to use. Second, the study sought to explore preliminary effects of the intervention on reducing stress and enhancing resilience by conducting a pilot randomized controlled trial. Methods: The feasibility study was conducted in three phases. First, the usability of the app was investigated in a pre-test with five participants using a thinking-aloud method. Second, the preliminary efficacy of the training was examined in a pilot randomized controlled trial. A sample of 30 employees were randomized either to receive the resilience training (n = 15) or to be member of a control group (n = 15). The primary outcome was measuring perceived stress. Secondary outcomes included measures of resilience and depressive symptoms. Third, semi-structured interviews were undertaken with six participants of the resilience training group on training content, motivation for use, and user experience. Results: Overall, results indicate that RESIST can be a feasible training for resilience promotion and stress reduction with high user satisfaction. Analysis of covariance showed that, relative to controls, participants who received RESIST reported significantly lower stress scores at post-intervention (F1,27 = 16.91, p < 0.001; Cohen's d = 1.57; 95 % CI 0.71–2.43) than controls. Significant differences, with moderate-to-large effect sizes, were also detected for general resilience and various resilience factors. Conclusions: Results are promising and provide hope that a hybrid web- and app-based resilience intervention based on strengths-based cognitive behavioral therapy can have a positive impact on dealing adequately with stress and improve resilience of employees

Evaluating the (cost-)effectiveness of guided and unguided Internet-based self-help for problematic alcohol use in employees - a three arm randomized controlled trial

BACKGROUND: Problematic alcohol consumption is associated with a high disease burden for affected individuals and has a detrimental impact on companies and society due to direct and indirect health costs. This protocol describes a study design to evaluate the (cost)-effectiveness of a guided and unguided Internet-based self-help intervention for employees called "GET.ON Clever weniger trinken" (be smart - drink less) compared to a waiting list control group. METHODS: In a three-arm randomized controlled trial, 528 German adults who are currently members of the workforce will be recruited by occupational health departments of major health insurance companies. Employees aged 18 and older displaying problematic drinking patterns (>21/14 drinks per week and an AUDIT score > 8/6 for men/women) will be randomly assigned to one of three following study conditions: 1. unguided web-based self-help for problematic drinking, 2. adherence-focused guided self-help, and 3. waiting list control. Self-report data will be collected at baseline (T1), 6 weeks (T2), and 6 months (T3) after randomization. The primary outcome will be the reduction of alcohol standard units during the 7 days prior to T2, using the Timeline Followback method. Cost-effectiveness analyses to determine direct and indirect costs will be conducted from the perspectives of employers and the society. Data will be analyzed on an intention-to-treat basis and per protocol. DISCUSSION: There is a need to identify effective low-threshold solutions to improve ill-health and reduce the negative economic consequences due to problematic alcohol drinking in workforces. If the proposed web-based intervention proves both to be efficacious and cost-effective, it may be a useful tool to increase utilization rates of interventions for problematic drinking in occupational settings. TRIAL REGISTRATION: German Register of Clinical Studies (DRKS): DRKS00006105 , date of registration: 2014-07-07

Reducing problematic alcohol use in employees: economic evaluation of guided and unguided web-based interventions alongside a three-arm randomized controlled trial.

AIMS: To perform an economic evaluation of guided and unguided internet-based interventions to reduce problematic alcohol consumption in employees compared with a waiting-list control condition (WLC) with unrestricted access to treatment-as-usual. DESIGN: A cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal and a cost-benefit analysis from the employer's perspective with a 6-month time horizon. SETTING: Open recruitment in the German working population. Participants were employees (178 males, 256 females, mean age 47 years) consuming at least 14 (women) or 21 (men) standard units of alcohol (SUAs) per week and scoring ≥ 8 (men) or 6 (women) on the Alcohol Use Disorders Identification Test. MEASUREMENTS: On-line questionnaires administered to assess SUAs and assess quality of life (AQoL-8D) and resource use. Outcome measure was responder (≤ 14/≤ 21 SUAs) for the CEA and quality-adjusted life years (QALYs) for the CUA. Net benefit regression was used to estimate cost-effectiveness for each study arm. Bootstrapping and sensitivity analyses were performed to account for uncertainty. INTERVENTIONS: Five weekly modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation, provided with adherence-focused guidance or without guidance . Controls were on a waiting-list. FINDINGS: From a societal perspective, the guided intervention had a probability of 55% (54%) of being the most efficient strategy at a willingness-to-pay (WTP) of €0 per responder (QALY) gained, compared with the unguided intervention and the control condition. At a WTP of €20 000 per QALY gained, the probability was 78%. From an employer's perspective, the guided intervention had a higher probability of a positive return on investment (81%) compared with the unguided intervention (58%). CONCLUSION: A guided internet-based intervention to reduce problematic alcohol consumption in employees appears to be both cost-beneficial and cost-effective

Efficacy of a web-based intervention with and without guidance for employees with risky drinking:results of a three-arm randomized controlled trial

Aims: To test the efficacy of a web-based alcohol intervention with and without guidance. Design: Three parallel groups with primary end-point after 6 weeks. Setting: Open recruitment in the German working population. Participants: Adults (178 males/256 females, mean age 47 years) consuming at least 21/14 weekly standard units of alcohol (SUA) and scoring ≥ 8/6 on the Alcohol Use Disorders Identification Test. Intervention: Five web-based modules including personalized normative feedback, motivational interviewing, goal setting, problem-solving and emotion regulation during 5 weeks. One intervention group received an unguided self-help version (n=146) and the second received additional adherence-focused guidance by eCoaches (n=144). Controls were on a waiting list with full access to usual care (n=144). Measurements: Primary outcome was weekly consumed SUA after 6 weeks. SUA after 6 months was examined as secondary outcome, next to numbers of participants drinking within the low-risk range, and general and work-specific mental health measures. Findings: All groups showed reductions of mean weekly SUA after 6 weeks (unguided: −8.0; guided: −8.5; control: −3.2). There was no significant difference between the unguided and guided intervention (P=0.324). Participants in the combined intervention group reported significantly fewer SUA than controls [B=−4.85, 95% confidence interval (CI)=−7.02 to −2.68, P < 0.001]. The intervention groups also showed significant reductions in SUA consumption after 6 months (B=−5.72, 95% CI=−7.71 to −3.73, P < 0.001) and improvements regarding general and work-related mental health outcomes after 6 weeks and 6 months. Conclusions: A web-based alcohol intervention, administered with or without personal guidance, significantly reduced mean weekly alcohol consumption and improved mental health and work-related outcomes in the German working population

GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

Background: Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT.Methods/design: A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation.Discussion: This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD.Trial registration: German Clinical Trial Registration (DRKS): DRKS00005025. © 2014 Ebert et al.; licensee BioMed Central Ltd