Who benefits from indirect prevention and treatment of depression using an online intervention for insomnia? Results from an individual-participant data meta-analysis.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics. METHODS: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree. RESULTS: IPD were obtained from four of seven eligible studies (N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment (d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up (d = -0.84 [95% CI -1.11 to -0.57]). In the subsample (n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators. CONCLUSIONS: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.

Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: A randomised-controlled pilot trial.

Insomnia is a primary symptom of shift work disorder, yet it remains undertreated. This randomised-controlled pilot trial examined the efficacy of a digital, guided cognitive behavioural therapy for insomnia adapted to shift work (SleepCare) in nurses with shift work disorder. The hypothesis was that SleepCare reduces insomnia severity compared with a waitlist control condition. A total of 46 unmedicated nurses suffering from shift work disorder with insomnia (age: 39.7 ± 12.1 years; 80.4% female) were randomised to the SleepCare group or the waitlist control group. The primary outcome measure was the Insomnia Severity Index. Other questionnaires on sleep, mental health and occupational functioning, sleep diary data and actigraphy data were analysed as secondary outcomes. Assessments were conducted before (T0), after the intervention/waitlist period (T1), and 6 months after treatment completion (T2). The SleepCare group showed a significant reduction in insomnia severity from T0 to T1 compared with the control condition (ß = -4.73, SE = 1.12, p < 0.001). Significant improvements were observed in sleepiness, dysfunctional beliefs about sleep, pre-sleep arousal, sleep effort, self-reported sleep efficiency and sleep onset latency. No significant effect was found in actigraphy data. Depressive and anxiety symptoms, cognitive irritation and work ability improved significantly. Overall, satisfaction and engagement with the intervention was high. SleepCare improved insomnia severity, sleep, mental health and occupational functioning. This is the first randomised-controlled trial investigating the efficacy of digital cognitive behavioural therapy for insomnia in a population suffering from shift work disorder with insomnia. Future research should further explore these effects with larger sample sizes and active control conditions.

Web-based occupational stress prevention in German micro- and small-sized enterprises - process evaluation results of an implementation study.

BACKGROUND: Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in micro- and small-sized enterprises (MSE). Main barriers include a lack of knowledge and limited resources, which could potentially be overcome with simplified web-based alternatives for occupational stress prevention. However, there is a lack of implementation research about web-based prevention in realistic settings of MSE. OBJECTIVE: The aim of this study is to evaluate the implementation process and success of an integrated web-based platform for occupational stress prevention ("System P") and to identify potential barriers for its uptake and use in MSE in Germany. METHODS: This study with a mixed-methods approach investigates eight process-related outcomes in a quantitative part I (adoption, reach, penetration, fidelity/dose, costs, acceptability) and a qualitative part II (acceptability, appropriateness and feasibility). Part I has a pre-post design with two measurements (6 months apart) with 98 individual participants and part II consists of 12 semi-structured interviews with managers and intercorporate stakeholders. RESULTS: Part I revealed shortcomings in the implementation process. Adoption/Reach: Despite extensive marketing efforts, less than 1% of the contacted MSE responded to the offer of System P. A total of 40 MSE registered, 24 of which, characterized by good psychosocial safety climate, adopted System P. Penetration: Within these 24 MSE, 15% of the employees used the system. Fidelity/Dose: 11 MSE started a psychosocial risk-assessment (PRA), and no MSE finished it. The stress-management training (SMT) was started by 25 users and completed by 8. COSTS: The use of System P was free of charge, but the time required to engage with was an indirect cost. Part II added insights on the perception of the web-based intervention: Acceptance of System P by users and stakeholders was good and it was assessed as appropriate for MSE. Results for feasibility were mixed. CONCLUSIONS: Although System P was generally perceived as useful and appropriate, only a small number of contacted MSE implemented it as intended. Prior experience and sensitivity for occupational (stress) prevention were mentioned as key facilitators, while (perceived) indirect costs were a key barrier. Enabling MSE to independently manage stress prevention online did not result in successful implementation. Increasing external support could be a solution. ⁺ 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.

The Evaluation of the GET.ON Nationwide Web-Only Treatment Service for Depression- and Stress-Related Symptoms: Naturalistic Trial.

BACKGROUND: GET.ON (HelloBetter) treatment interventions have been shown to be efficacious in multiple randomized controlled trials. OBJECTIVE: This study evaluated the effectiveness of 2 GET.ON interventions, GET.ON Mood Enhancer and GET.ON Stress, in a national digital mental health service implemented across Germany. METHODS: Following an initial web-based questionnaire, participants were allocated to either intervention based on their baseline symptom severity and personal choice and received a semistandardized guided, feedback-on-demand guided, or self-guided version of the treatment. Uncontrolled routine care data from 851 participants were analyzed using a pretest-posttest design. Half of the participants (461/851, 54.2%) were allocated to the stress intervention (189/461, 41% semistandardized; 240/461, 52% feedback on demand; and 32/461, 6.9% self-guided), and almost all participants in the mood intervention (349/352, 99.2%) received semistandardized guidance. RESULTS: Results on depression-related symptom severity indicated a reduction in reported symptoms, with a large effect size of d=-0.92 (95% CI -1.21 to -0.63). Results on perceived stress and insomnia indicated a reduction in symptom severity, with large effect sizes of d=1.02 (95% CI -1.46 to -0.58) and d=-0.75 (95% CI -1.10 to -0.40), respectively. A small percentage of participants experienced deterioration in depression-related symptoms (11/289, 3.8%), perceived stress (6/296, 2%), and insomnia (5/252, 2%). After completing treatment, 51.9% (150/289) of participants showed a clinically reliable change in depression-related symptoms, whereas 20.4% (59/289) achieved a close to symptom-free status. Similar improvements were observed in perceived stress and insomnia severity. Guidance moderated the effectiveness of and adherence to the interventions in reducing depressive symptom severity. Effect sizes on depression-related symptom severity were d=-1.20 (95% CI -1.45 to -0.93) for the semistandardized group, d=-0.36 (95% CI -0.68 to -0.04) for the feedback-on-demand group, and d=-0.83 (95% CI -1.03 to -0.63) for the self-guided group. Furthermore, 47.6% (405/851) of the participants completed all modules of the intervention. Participant satisfaction was high across all patient groups and both interventions; 89.3% (242/271) of participants would recommend it to a friend in need of similar help. Limitations include the assignment to treatments and guidance formats based on symptom severity. Furthermore, part of the differences in symptom change between groups must be assumed to be due to this baseline difference in the measures. CONCLUSIONS: Future digital health implementation and routine care research should focus on monitoring symptom deterioration and other negative effects, as well as possible predictors of deterioration and the investigation of individual patient trajectories. In conclusion, this study supports the effectiveness of tailored digital mental health services in routine care for depression- and stress-related symptoms in Germany. The results highlight the importance of guidance in delivering internet-based cognitive behavioral therapy interventions and provide further evidence for its potential delivered as web-only solutions for increasing access to and use of psychological treatments.

[Apps for tinnitus? A systematic review on quality, intervention components, and behavior change techniques]. / Mit Apps gegen den Tinnitus? Ein systematisches Review zu Qualität, Interventionselementen und Techniken der Verhaltensänderung.

BACKGROUND: Various smartphone applications (apps) for people with tinnitus are available and promise tinnitus relief. Yet, it is difficult for people suffering from tinnitus and healthcare professionals to estimate their quality, potential, or risks. The current study aims to generate an overview of available tinnitus apps in the German language and to offer orientation for research and healthcare providers. METHOD: The most prominent stores were searched systematically (November 2020-April 2021; Google Play Store and Apple App Store). Apps specifically developed for tinnitus were evaluated by two independent raters using multiple approaches: a) a quality screening was performed using the German version of the Mobile App Rating Scale (MARS-G), b) intervention components were assessed using a newly developed list of categories, and c) implemented strategies for active tinnitus management were analyzed using behavior change techniques (BCTs). RESULTS: The search yielded 1073 apps, of which 21 apps were analyzed. The apps' overall quality as assessed by MARS­G was average (M = 3.37, SD = 039). A lot of apps offered sounds (n = 18) and information (n = 9) or assessed tinnitus characteristics (n = 13). Out of 93 BCTs, 24 were identified at least once. Only one app was evaluated in non-randomized trials. CONCLUSION: Although a variety of apps are available, most of them focus on a few intervention components (e.g., sounds or information). Therefore, apps do not exploit their potential to impart important evidence-based content for tinnitus management. The app evaluation using multiple approaches points out potential for improvement.

Effectiveness of an internet-based intervention to improve sleep difficulties in a culturally diverse sample of international students: A randomised controlled pilot study.

Sleep difficulties are widespread among international students. Internet-based interventions are suggested as a low-threshold treatment option but may require cultural adaptation among culturally diverse populations. The present pilot study investigated the effectiveness and acceptance of an internet-based intervention to improve sleep difficulties in international students. A total of 81 international students of 36 nationalities were randomly assigned to the intervention (n = 41) or waitlist control group (n = 40). The intervention group received immediate access to a culturally non-adapted unguided internet-based sleep intervention consisting of three modules based on sleep hygiene and cognitive techniques to reduce rumination. At baseline, 4 and 12 weeks after randomisation, insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, depression, anxiety, perceived stress, well-being, presenteeism, mental health literacy) were assessed. Data were analysed using linear multi-level analyses. Additionally, satisfaction and perceived cultural appropriateness of the intervention were evaluated by international students after 4 weeks, and compared with ratings of German students, who represent the original target group. Insomnia severity improved over time in the intervention group compared to the control group, revealing a significant estimated mean difference of -5.60 (Hedges' g = 0.84, p < 0.001) after 12 weeks. Satisfaction and perceived cultural appropriateness was high and comparable to that of German students. The present study shows that a culturally non-adapted internet-based sleep intervention can be a low-threshold treatment option to help meet the high demand for mental healthcare among international students. It thus indicates that cultural adaptation might not represent a precondition for providing effective internet-based sleep interventions to this target group.

Effectiveness of an Internet-Based Self-Help Intervention versus Public Mental Health Advice to Reduce Worry during the COVID-19 Pandemic: A Pragmatic, Parallel-Group, Randomized Controlled Trial.

INTRODUCTION: The mental health burden for the general population due to the COVID-19 pandemic has been highlighted. Evidence on effective, easily accessible public health interventions to reduce worry, a major transdiagnostic risk-factor for, e.g., anxiety and depression, is scarce. OBJECTIVE: In a pragmatic randomized controlled trial, we aimed to assess whether an internet cognitive-behavioral self-help intervention could reduce worry more than public mental health advice in the general population. METHODS: Eligible internet users above the age of 18 were recruited from the German general population and randomly assigned, to either get.calm-move.on (GCMO), a 10-day unguided, internet-based self-help intervention, or mental health advice waiting group (MHA-W, receiving officially endorsed mental health recommendations). The primary outcome was level of worry, using the Penn State Worry Questionnaire (PSWQ), 2 weeks after randomization. Baseline assessment and 2-month and 6-month follow-ups were conducted. The trial was registered at the German Clinical Trials Registry (DRKS00021153). RESULTS: Between April 7, 2020 and December 11, 2020, we randomly assigned 351 individuals to receive either GCMO (n = 175) or MHA-W (n = 176). Participants receiving GCMO (PSWQ = 46.6; change -10.3) reported significantly less worrying at post-intervention (F1,219 = 12.9; p < 0.001; d = 0.38) than MHA-W controls (PSWQ = 51.6; change -5.1). Improvements were also seen on most secondary outcomes, including symptoms of anxiety and depression, general well-being, resiliency, and emotion regulation skills. Improvements made from baseline were stable until the 6-month follow-up. CONCLUSIONS: This internet-based self-help intervention providing cognitive-behavioral techniques to cope with the threatening pandemic situation is effective in reducing worry in the general population and should complement existing and potentially effective mental health recommendations.

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.

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.

BACKGROUND: Work 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. OBJECTIVE: The 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. METHODS: A 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). RESULTS: Study 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<.001) and T3 (d=0.65, 95% CI 0.41-0.90, P<.001). Mediation analyses indicated that occupational self-efficacy mediated the beneficial effect of the SMI on stress directly. Furthermore, the analyses revealed a significant indirect effect of occupational self-efficacy via rewards (b=0.18, t259=4.52, P<.001), but not via efforts (b=0.01, t259=0.27, P>.05) while efforts still had a negative impact on stress (b=0.46, t257=2.32, P<.05). CONCLUSIONS: The 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 REGISTRATION: German Clinical Trials Register DRKS00005990; https://tinyurl.com/23fmzfu3.

[Chronic Occupational Stress: Psychotherapeutic Treatment Approaches]. / Chronischer beruflicher Stress: Behandlungsansätze mit Psychotherapie.

Mental illness is a central risk factor for occupational incapacity and premature retirement. One of the contributors for mental illness as well as somatic diseases is chronic stress at work. Therefore, it is essential for affected individuals to get professional help in order to identify and ease mental stress at work as well as to regain their working ability and prevent relapses. Job-related stress models facilitate the identification of health-relevant stress factors on an individual and organizational level. This enables therapists to use job-related treatment approaches. These should comprise the following elements: motivational support, cognitive coping strategies, provision of knowledge and exercises for the competence to act and strategies for recovery, and social counseling. Promising results in the growing field of internet-based occupational e-mental health allow us to expect good effects in prevention and psychotherapeutic treatment of occupational stress.

[Curriculum Hannover - Web-based vs. Analogue Psychotherapeutic aftercare after Psychosomatic Rehabilitation and vs. Care as Usual]. / Curriculum Hannover ­ webbasierte vs. analoge Durchführung der psychosomatischen Nachsorge und vs. Care as usual.

PURPOSE: In order to maintain the effect achieved in the psychosomatic rehabilitation measure, psychosomatic rehabilitation aftercare is indicated for most rehabilitation patients. Due to the low availability of aftercare therapists close to home, the use of digital offers is a possibility to enable access independent of location. The aim of the study was to evaluate the therapeutic effects of web-based aftercare in comparison to face-to-face (F2F) therapy (both on the conceptual basis of the Curriculum Hannover) in the equivalence study and to no standardized aftercare (care as usual, CAU) in the superiority study. METHODS: 300 rehabilitation patients with an indication for psychosomatic aftercare were assigned to the equivalence study if an aftercare service close to home was available and then randomized to F2F or online aftercare. Without a service close to home, the participants were assigned to the superiority study and randomized to online or CAU group. The outcomes (primary: psychological and somatoform complaints, secondary: subscales of the HEALTH-49, employment prognosis, ability to work) were assessed by online questionnaires at the end of rehabilitation, 9 or 12 and 15 or 18 months after rehabilitation and evaluated with multiple imputation and intention-to-treat-analyses. For the primary outcome, a sensitivity analysis was also carried out on the basis of the completed dataset. RESULTS: After excluding non-adherent participants, n=142 participants were evaluated in the equivalence study and n=111 in the superiority study. In the equivalence study, no significant differences (d=0,28 and 0,10 with ITT-analyses; d=0,09 and 0,03 with completed dataset) were found between online and F2F follow-up with regard to short-term and long-term psychological and somatoform complaints. In the superiority study, long-term psychological and somatoform complaints decrease in the online group, while in the CAU group they first decreased at T2 (d=0,56) and increased again at T3 (d=0,72). The latter finding is confirmed with the analysis of the completed dataset (d=0,12), while an increase was seen in the online group at T3 (d=0,10). CONCLUSION: According to the results of the present study, web-based psychosomatic aftercare seems to have a longer-term advantage for rehabilitants without access to previous aftercare. Compared to F2F implementation, it can be considered equivalent.

Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial.

INTRODUCTION: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. OBJECTIVE: The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. METHODS: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. RESULTS: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (ß = -0.19, 95% CI -0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. CONCLUSION: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

Efficacy and Moderators of Internet-Based Interventions in Adults with Subthreshold Depression: An Individual Participant Data Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Evidence on effects of Internet-based interventions to treat subthreshold depression (sD) and prevent the onset of major depression (MDD) is inconsistent. OBJECTIVE: We conducted an individual participant data meta-analysis to determine differences between intervention and control groups (IG, CG) in depressive symptom severity (DSS), treatment response, close to symptom-free status, symptom deterioration and MDD onset as well as moderators of intervention outcomes. METHODS: Randomized controlled trials were identified through systematic searches via PubMed, PsycINFO, Embase and Cochrane Library. Multilevel regression analyses were used to examine efficacy and moderators. RESULTS: Seven trials (2,186 participants) were included. The IG was superior in DSS at all measurement points (posttreatment: 6-12 weeks; Hedges' g = 0.39 [95% CI: 0.25-0.53]; follow-up 1: 3-6 months; g = 0.30 [95% CI: 0.15-0.45]; follow-up 2: 12 months, g = 0.27 [95% CI: 0.07-0.47], compared with the CG. Significantly more participants in the IG than in the CG reached response and close to symptom-free status at all measurement points. A significant difference in symptom deterioration between the groups was found at the posttreatment assessment and follow-up 2. Incidence rates for MDD onset within 12 months were lower in the IG (19%) than in the CG (26%). Higher initial DSS and older age were identified as moderators of intervention effect on DSS. CONCLUSIONS: Our findings provide evidence for Internet-based interventions to be a suitable low-threshold intervention to treat individuals with sD and to reduce the incidence of MDD. This might be particularly true for older people with a substantial symptom burden.

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 ≥ 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.

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.

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.

Quality and Adoption of COVID-19 Tracing Apps and Recommendations for Development: Systematic Interdisciplinary Review of European Apps.

BACKGROUND: Simulation study results suggest that COVID-19 contact tracing apps have the potential to achieve pandemic control. Concordantly, high app adoption rates were a stipulated prerequisite for success. Early studies on potential adoption were encouraging. Several factors predicting adoption rates were investigated, especially pertaining to user characteristics. Since then, several countries have released COVID-19 contact tracing apps. OBJECTIVE: This study's primary aim is to investigate the quality characteristics of national European COVID-19 contact tracing apps, thereby shifting attention from user to app characteristics. The secondary aim is to investigate associations between app quality and adoption. Finally, app features contributing to higher app quality were identified. METHODS: Eligible COVID-19 contact tracing apps were those released by national health authorities of European Union member states, former member states, and countries of the European Free Trade Association, all countries with comparable legal standards concerning personal data protection and app use voluntariness. The Mobile App Rating Scale was used to assess app quality. An interdisciplinary team, consisting of two health and two human-computer interaction scientists, independently conducted Mobile App Rating Scale ratings. To investigate associations between app quality and adoption rates and infection rates, Bayesian linear regression analyses were conducted. RESULTS: We discovered 21 national COVID-19 contact tracing apps, all demonstrating high quality overall and high-level functionality, aesthetics, and information quality. However, the average app adoption rate of 22.9% (SD 12.5%) was below the level recommended by simulation studies. Lower levels of engagement-oriented app design were detected, with substantial variations between apps. By regression analyses, the best-case adoption rate was calculated by assuming apps achieve the highest ratings. The mean best-case adoption rates for engagement and overall app quality were 39.5% and 43.6%, respectively. Higher adoption rates were associated with lower cumulative infection rates. Overall, we identified 5 feature categories (symptom assessment and monitoring, regularly updated information, individualization, tracing, and communication) and 14 individual features that contributed to higher app quality. These 14 features were a symptom checker, a symptom diary, statistics on COVID-19, app use, public health instructions and restrictions, information of burden on health care system, assigning personal data, regional updates, control over tracing activity, contact diary, venue check-in, chats, helplines, and app-sharing capacity. CONCLUSIONS: European national health authorities have generally released high quality COVID-19 contact tracing apps, with regard to functionality, aesthetics, and information quality. However, the app's engagement-oriented design generally was of lower quality, even though regression analyses results identify engagement as a promising optimization target to increase adoption rates. Associations between higher app adoption and lower infection rates are consistent with simulation study results, albeit acknowledging that app use might be part of a broader set of protective attitudes and behaviors for self and others. Various features were identified that could guide further engagement-enhancing app development.

Evaluating a Hybrid Web-Based Training Program for Panic Disorder and Agoraphobia: Randomized Controlled Trial.

BACKGROUND: Previous studies provide evidence for the effectiveness of web-based interventions for panic disorder with and without agoraphobia. Smartphone-based technologies hold significant potential for further enhancing the accessibility and efficacy of such interventions. OBJECTIVE: This randomized controlled trial aims to evaluate the efficacy of a guided, hybrid web-based training program based on cognitive behavioral therapy for adults with symptoms of panic disorder. METHODS: Participants (N=92) with total scores in the Panic and Agoraphobia Scale ranging from 9 to 28 were recruited from the general population and allocated either to a hybrid intervention (GET.ON Panic) or to a wait-list control group. The primary outcome was the reduction in panic symptoms, as self-assessed using a web-based version of the Panic and Agoraphobia Scale. RESULTS: Analysis of covariance-based intention-to-treat analyses revealed a significantly stronger decrease in panic symptoms posttreatment (F=9.77; P=.002; Cohen d=0.66; 95% CI 0.24-1.08) in the intervention group than in the wait-list control group. Comparisons between groups of the follow-up measures at 3 and 6 months yielded even stronger effects (3-month follow-up: F=17.40, P<.001, Cohen d=0.89, 95% CI 0.46-1.31; 6-month follow-up: F=14.63, P<.001, Cohen d=0.81, 95% CI 0.38-1.24). CONCLUSIONS: Hybrid web-based training programs may help reduce the symptoms of panic disorder and hence play an important role in improving health care for patients with this debilitating disorder. TRIAL REGISTRATION: German Clinical Trial Register DRKS00005223; https://tinyurl.com/f4zt5ran. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1745-6215-15-427.

Effectiveness and Moderators of an Internet-Based Mobile-Supported Stress Management Intervention as a Universal Prevention Approach: Randomized Controlled Trial.

BACKGROUND: Emerging evidence indicates the effectiveness of internet-based mobile-supported stress management interventions (iSMIs) in highly stressed employees. It is yet unclear, however, whether iSMIs are also effective without a preselection process in a universal prevention approach, which more closely resembles routine occupational health care. Moreover, evidence for whom iSMIs might be suitable and for whom not is scarce. OBJECTIVE: The aim of this study was to evaluate the iSMI GET.ON Stress in a universal prevention approach without baseline inclusion criteria and to examine the moderators of the intervention effects. METHODS: A total of 396 employees were randomly assigned to the intervention group or the 6-month waiting list control group. The iSMI consisted of 7 sessions and 1 booster session and offered no therapeutic guidance. Self-report data were assessed at baseline, 7 weeks, and at 6 months following randomization. The primary outcome was perceived stress. Several a priori defined moderators were explored as potential effect modifiers. RESULTS: Participants in the intervention group reported significantly lower perceived stress at posttreatment (d=0.71, 95% CI 0.51-0.91) and at 6-month follow-up (d=0.61, 95% CI 0.41-0.81) compared to those in the waiting list control group. Significant differences with medium-to-large effect sizes were found for all mental health and most work-related outcomes. Resilience (at 7 weeks, P=.04; at 6 months, P=.01), agreeableness (at 7 weeks, P=.01), psychological strain (at 6 months, P=.04), and self-regulation (at 6 months, P=.04) moderated the intervention effects. CONCLUSIONS: This study indicates that iSMIs can be effective in a broad range of employees with no need for preselection to achieve substantial effects. The subgroups that might not profit had extreme values on the respective measures and represented only a very small proportion of the investigated sample, thereby indicating the broad applicability of GET.ON Stress. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005699; https://www.drks.de/DRKS00005699.

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Health-Economic Evaluation From the Societal and Public Health Care Perspective Alongside a Randomized Controlled Trial.

BACKGROUND: The evidence base for internet-based cognitive behavioral therapy for insomnia (iCBT-I) is firm; however, little is known about iCBT-I's health-economic effects. OBJECTIVE: This study aimed to evaluate the cost-effectiveness and cost-utility of iCBT-I in reducing insomnia among schoolteachers. METHODS: Schoolteachers (N=128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a wait list control group, both with unrestricted access to treatment as usual. Health care use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and a public health care perspective. Costs were related to symptom-free status (score <8 on the insomnia severity index) and quality-adjusted life years (QALYs) gained. Sampling error was handled using nonparametric bootstrapping. RESULTS: Statistically significant differences favoring the intervention group were found for both health outcomes (symptom-free status yes or no: ß=.30; 95% CI 0.16-0.43; QALYs: ß=.019, 95% CI 0.01-0.03). From a societal perspective, iCBT-I had a 94% probability of dominating the wait list control for both health outcomes. From a public health care perspective, iCBT-I was more effective but also more expensive than the wait list control, resulting in an incremental cost-effectiveness ratio of €650 per symptom-free individual. In terms of QALYs, the incremental cost-effectiveness ratio was €11,285. At a willingness-to-pay threshold of €20,000 per QALY gained, the intervention's probability of being cost-effective was 89%. CONCLUSIONS: Our trial indicates that iCBT could be considered as a good value-for-money intervention for insomnia. TRIAL REGISTRATION: German Clinical Trial Registry: DRKS00004700; https://tinyurl.com/2nnk57jm. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1745-6215-14-169.

Efficacy of a smartphone-based intervention - "Holidaily" - promoting recovery behaviour in workers after a vacation: study protocol for a randomised controlled trial.

BACKGROUND: While work-related rumination increases the risk of acute stressors developing into chronic load reactions and adverse health, mental detachment has been suggested as a way to interrupt this chain. Despite the importance of mentally detaching from work during leisure time, workers seem to struggle to disengage and, instead, experience the constant mental representation of work-related stressors, regardless of their absence. Those who struggle with work-related rumination could benefit from an easy-access intervention that fosters mental detachment by promoting recreational activities. Especially during vacations, workers appear to naturally engage in sufficient recovery activities; however, this beneficial behaviour is not sustained. The smartphone app-based intervention "Holidaily" promotes recovery behaviour and, thus, mental detachment from work with the intension of extending the beneficial effects of workers' vacations into their daily working life. METHODS: This randomised-controlled trial (RCT) evaluates the efficacy of "Holidaily". The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems. The sample includes workers, who are awaiting to go on vacation and are randomly assigned to either the intervention (IG) or a waitlist-control group (CG). The IG receives two weeks pre-vacation access to Holidaily, while the CG receives access two weeks post-vacation. On a daily basis participants in the IG are provided with three options promoting recreational activities and beneficial recovery experiences. Online questionnaires are distributed to all participants at several timepoints. The primary outcome measure assesses participants' work-related rumination (Irritation Scale). A significant difference two weeks post-vacation is expected, favouring the IG. Secondary outcomes include symptoms of depression, insomnia severity, emotional exhaustion, thinking about work, recovery experiences, vacation specifics, work and personal characteristics. To help explain the intervention's effect, explorative analyses will investigate the mediation properties of the frequency of engaging in recreational activities and the moderation properties of Holidaily users' experiences. DISCUSSION: If successful, workers will maintain their recovery behaviour beyond their vacation into daily working life. Findings could, therefore, provide evidence for low-intensity interventions that could be very valuable from a public-health perspective. App-based interventions have greater reach; hence, more workers might access preventative tools to protect themselves from developing adverse health effects linked to work-related rumination. Further studies will still be needed to investigate whether the vacation phenomenon of "lots of fun quickly gone" can be defied and long-term benefits attained. TRIAL REGISTRATION: German Clinical Trials Registration DRKS00013650 . Registered retrospectively 15.01.2018.