Effectiveness of an online recovery training for employees exposed to blurred boundaries between work and non-work: Bayesian analysis of a randomised controlled trial.

BACKGROUND: Blurred work-non-work boundaries can have negative effects on mental health, including sleep. OBJECTIVES: In a randomised control trial, we aimed to assess the effectiveness of an online recovery training programme designed to improve symptoms of insomnia in a working population exposed to blurred boundaries. METHODS: 128 participants with severe insomnia symptoms (Insomnia Severity Index ≥15) and working under blurred work and non-work conditions (segmentation supplies <2.25) were randomly assigned to either the recovery intervention or a waitlist control group (WLC). The primary outcome was insomnia severity, assessed at baseline, after 2 months (T2) and 6 months (T3). FINDINGS: A greater reduction in insomnia was observed in the intervention compared with the WLC group at both T2 (d=1.51; 95% CI=1.12 o 1.91) and T3 (d=1.63; 95% CI=1.23 to 2.03]. This was shown by Bayesian analysis of covariance (ANCOVA), whereby the ANCOVA model yielded the highest Bayes factor (BF 10=3.23×e60] and a 99.99% probability. Likewise, frequentist analysis revealed significantly reduced insomnia at both T2 and T3. Beneficial effects were found for secondary outcomes including depression, work-related rumination, and mental detachment from work. Study attrition was 16% at T2 and 44% at T3. CONCLUSIONS: The recovery training was effective in reducing insomnia symptoms, work related and general indicators of mental health in employees exposed to blurred boundaries, both at T2 and T3. CLINICAL IMPLICATIONS: In addition to demonstrating the intervention's effectiveness, this study exemplifies the utilisation of the Bayesian approach in a clinical context and shows its potential to empower recipients of interventional research by offering insights into result probabilities, enabling them to draw informed conclusions. TRIAL REGISTRATION NUMBER: German Clinical Trial Registration (DRKS): DRKS00006223, https://drks.de/search/de/trial/DRKS00006223.

Effectiveness of One Videoconference-Based Exposure and Response Prevention Session at Home in Adjunction to Inpatient Treatment in Persons With Obsessive-Compulsive Disorder: Nonrandomized Study.

BACKGROUND: Therapist-guided exposure and response prevention (ERP) for the treatment of obsessive-compulsive disorder (OCD) is frequently conducted within clinical settings but rarely at places where patients are usually confronted with OCD symptom-provoking situations in daily life (eg, at home). OBJECTIVE: This study aimed to investigate patients' views on 1 ERP session at home via videoconference and its impact on treatment outcome. METHODS: A total of 64 inpatients with OCD received 1 session of therapist-guided videoconference-based ERP at home in adjunction to a multimodal inpatient treatment between 2015 and 2020. RESULTS: Compared with 64 age- and sex-matched controls who received a multimodal inpatient treatment without 1 session of videoconference-based ERP at home, patients who received 1 session of videoconference-based ERP in adjunction to a multimodal inpatient treatment showed stronger reductions in OCD symptom severity from admission to discharge. Before the videoconference-based ERP session, patients reported high rationale credibility and treatment expectancy. After the videoconference-based ERP session, patients reported medium-to-high positive mood as well as depth and smoothness of the session, and they perceived the working alliance as high. CONCLUSIONS: Results highlight the importance of administering therapist-guided ERP sessions in patients' natural environment to enhance treatment response in OCD. Videoconference-based ERP as add-on to treatment as usual is, therefore, a promising approach to facilitate the application of ERP in patients' natural environment and foster the generalization of ERP conducted in clinical settings.

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.

Are web-based stress management interventions effective as an indirect treatment for depression? An individual participant data meta-analysis of six randomised trials.

QUESTION: Depression is highly prevalent and associated with numerous adverse consequences for both individuals and society. Due to low uptake of direct treatment, interventions that target related, but less stigmatising problems, such as perceived stress, have emerged as a new research paradigm.This individual participant data (IPD) meta-analysis examines if a web-based stress management intervention can be used as an 'indirect' treatment of depression. STUDY SELECTION AND ANALYSIS: Bayesian one-stage models were used to estimate pooled effects on depressive symptom severity, minimally important improvement and reliable deterioration. The dose-response relationship was examined using multilevel additive models, and IPD network meta-analysis was employed to estimate the effect of guidance. FINDINGS: In total, N=1235 patients suffering from clinical-level depression from K=6 randomised trials were included. Moderate-to-large effects were found on depressive symptom severity at 7 weeks post-intervention (d=-0.65; 95% credibility interval (CrI): -0.84 to -0.48) as measured with the Center for Epidemiological Studies' Depression Scale. Effects were sustained at 3-month follow-up (d=-0.74; 95% CrI: -1.01 to -0.48). Post-intervention symptom severity was linearly related to the number of completed sessions. The incremental impact of guidance was estimated at d=-0.25 (95% CrI: -1.30 to 0.82), with a 35% posterior probability that guided and unguided formats produce equivalent effects. CONCLUSIONS: Our results indicate that web-based stress management can serve as an indirect treatment, yielding effects comparable with direct interventions for depression. Further research is needed to determine if such formats can indeed increase the utilisation of evidence-based treatment, and to corroborate the favourable effects for human guidance. STUDY REGISTRATION: Open material repository: osf.io/dbjc8, osf.io/3qtbe. TRIAL REGISTRATION NUMBER: German Clinical Trial Registration (DRKS): DRKS00004749, DRKS00005112, DRKS00005384, DRKS00005687, DRKS00005699, DRKS00005990.

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.

Predicting effects of a digital stress intervention for patients with depressive symptoms: Development and validation of meta-analytic prognostic models using individual participant data.

OBJECTIVE: Digital stress interventions could be helpful as an "indirect" treatment for depression, but it remains unclear for whom this is a viable option. In this study, we developed models predicting individualized benefits of a digital stress intervention on depressive symptoms at 6-month follow-up. METHOD: Data of N = 1,525 patients with depressive symptoms (Center for Epidemiological Studies' Depression Scale, CES-D ≥ 16) from k = 6 randomized trials (digital stress intervention vs. waitlist) were collected. Prognostic models were developed using multilevel least absolute shrinkage and selection operator and boosting algorithms, and were validated using bootstrap bias correction and internal-external cross-validation. Subsequently, expected effects among those with and without a treatment recommendation were estimated based on clinically derived treatment assignment cut points. RESULTS: Performances ranged from R² = 21.0%-23.4%, decreasing only slightly after model optimism correction (R² = 17.0%-19.6%). Predictions were greatly improved by including an interim assessment of depressive symptoms (optimism-corrected R2 = 32.6%-35.6%). Using a minimally important difference of d = -0.24 as assignment cut point, approximately 84.6%-93.3% of patients are helped by this type of intervention, while the remaining 6.7%-15.4% would experience clinically negligible benefits (δ^ = -0.02 to -0.19). Using reliable change as cut point, a smaller subset (39.3%-46.2%) with substantial expected benefits (δ^ = -0.68) receives a treatment recommendation. CONCLUSIONS: Meta-analytic prognostic models applied to individual participant data can be used to predict differential benefits of a digital stress intervention as an indirect treatment for depression. While most patients seem to benefit, the developed models could be helpful as a screening tool to identify those for whom a more intensive depression treatment is needed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Finding the Best Match - a Case Study on the (Text-)Feature and Model Choice in Digital Mental Health Interventions.

With the need for psychological help long exceeding the supply, finding ways of scaling, and better allocating mental health support is a necessity. This paper contributes by investigating how to best predict intervention dropout and failure to allow for a need-based adaptation of treatment. We systematically compare the predictive power of different text representation methods (metadata, TF-IDF, sentiment and topic analysis, and word embeddings) in combination with supplementary numerical inputs (socio-demographic, evaluation, and closed-question data). Additionally, we address the research gap of which ML model types - ranging from linear to sophisticated deep learning models - are best suited for different features and outcome variables. To this end, we analyze nearly 16.000 open-text answers from 849 German-speaking users in a Digital Mental Health Intervention (DMHI) for stress. Our research proves that - contrary to previous findings - there is great promise in using neural network approaches on DMHI text data. We propose a task-specific LSTM-based model architecture to tackle the challenge of long input sequences and thereby demonstrate the potential of word embeddings (AUC scores of up to 0.7) for predictions in DMHIs. Despite the relatively small data set, sequential deep learning models, on average, outperform simpler features such as metadata and bag-of-words approaches when predicting dropout. The conclusion is that user-generated text of the first two sessions carries predictive power regarding patients' dropout and intervention failure risk. Furthermore, the match between the sophistication of features and models needs to be closely considered to optimize results, and additional non-text features increase prediction results. Supplementary Information: The online version contains supplementary material available at 10.1007/s41666-023-00148-z.

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.

[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.

The feasibility of using Apple's ResearchKit for recruitment and data collection: Considerations for mental health research.

In 2015, Apple launched an open-source software framework called ResearchKit. ResearchKit provides an infrastructure for conducting remote, smartphone-based research trials through the means of Apple's App Store. Such trials may have several advantages over conventional trial methods including the removal of geographic barriers, frequent assessments of participants in real-life settings, and increased inclusion of seldom-heard communities. The aim of the current study was to explore the feasibility of participant recruitment and the potential for data collection in the non-clinical population in a smartphone-based trial using ResearchKit. As a case example, an app called eMovit, a behavioural activation (BA) app with the aim of helping users to build healthy habits was used. The study was conducted over a 9-month period. Any iPhone user with access to the App Stores of The Netherlands, Belgium, and Germany could download the app and participate in the study. During the study period, the eMovit app was disseminated amongst potential users via social media posts (Twitter, Facebook, LinkedIn), paid social media advertisements (Facebook), digital newsletters and newspaper articles, blogposts and other websites. In total, 1,788 individuals visited the eMovit landing page. A total of 144 visitors subsequently entered Apple's App Store through that landing page. The eMovit product page was viewed 10,327 times on the App Store. With 79 installs, eMovit showed a conversion rate of 0.76% from product view to install of the app. Of those 79 installs, 53 users indicated that they were interested to participate in the research study and 36 subsequently consented and completed the demographics and the participants quiz. Fifteen participants completed the first PHQ-8 assessment and one participant completed the second PHQ-8 assessment. We conclude that from a technological point of view, the means provided by ResearchKit are well suited to be integrated into the app process and thus facilitate conducting smartphone-based studies. However, this study shows that although participant recruitment is technically straightforward, only low recruitment rates were achieved with the dissemination strategies applied. We argue that smartphone-based trials (using ResearchKit) require a well-designed app dissemination process to attain a sufficient sample size. Guidelines for smartphone-based trial designs and recommendations on how to work with challenges of mHealth research will ensure the quality of these trials, facilitate researchers to do more testing of mental health apps and with that enlarge the evidence-base for mHealth.

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.

[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.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep).

INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.

A Web-Based Stress Management Intervention for University Students in Indonesia (Rileks): Feasibility Study Using a Pretest-Posttest Design.

BACKGROUND: University students are susceptible to excessive stress. A web-based stress management intervention holds promise to improve stress but is still at a novel stage in Indonesia. OBJECTIVE: The aim of this paper was to report the feasibility of the intervention we developed-Rileks-among university students in Indonesia in terms of acceptability and usability, and to propose recommendations for future improvements. METHODS: A single-group pretest and posttest design was used. Participants with scores of 15 or higher on the stress subscale of the 42-item Depression Anxiety Stress Scales were given access to the intervention (N=68). The main outcome measures were the 8-item Client Satisfaction Questionnaire (CSQ-8) score, the System Usability Scale (SUS) score, and intervention uptake. Participants' experience in each session was evaluated using closed- and open-ended questions for future improvements. Descriptive statistics were used to examine primary outcome and qualitative session evaluations. Participants' responses to each topic of the open questions were summarized. RESULTS: The intervention was evaluated as being satisfactory (CSQ-8 mean score 21.89, SD 8.72; range 8-32). However, the intervention's usability was still below expectation (SUS mean score 62.8, SD 14.74; range 0-100). The core modules were completed by 10 out of 68 participants (15%), and the study dropout rate was 63% (43/68) at postassessment. In general, the module content was rated positively, with some notes for improvement covering content and technical aspects. CONCLUSIONS: This study indicates that Rileks is potentially feasible for Indonesian university students. In order to be optimally applied in such a context and before scaling up web-based interventions in Indonesia, in general, further development and refinement are needed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11493.

Engaging Refugees With a Culturally Adapted Digital Intervention to Improve Sleep: A Randomized Controlled Pilot Trial.

Refugees are exposed to multiple stressors affecting their mental health. Given various barriers to mental healthcare in the arrival countries, innovative healthcare solutions are needed. One such solution could be to offer low-threshold treatments, for example by culturally adapting treatments, providing them in a scalable format, and addressing transdiagnostic symptoms. This pilot trial examined the feasibility, acceptance, and preliminary effectiveness of a culturally adapted digital sleep intervention for refugees. Sixty-six refugees participated, with 68.2% of them seeking psychological help for the first time. Only three participants did not show clinically significant insomnia severity, 93.9% reported past traumatic experiences. Participants were randomly assigned to the intervention group (IG) or the waitlist control group (CG). Insomnia severity, measured by the Insomnia Severity Index, and secondary outcomes (sleep quality, fear of sleep, fatigue, depression, wellbeing, mental health literacy) were assessed at baseline, 1 and 3 months after randomization. The self-help intervention included four modules on sleep hygiene, rumination, and information on mental health conditions associated with sleep disturbances. 66.7% of the IG completed all modules. Satisfaction with the intervention and its perceived cultural appropriateness were high. Linear multilevel analyses revealed a small, non-significant intervention effect on insomnia severity of Hedge's g = 0.28 at 3-months follow-up, comparing the IG to the CG [F 2, 60 = 0.88, p = 0.421]. This non-confirmatory pilot trial suggests that low-threshold, viable access to mental healthcare can be offered to multiple burdened refugees by culturally adapting an intervention, providing it in a scalable format, and addressing a transdiagnostic symptom.

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.

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.

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: 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 [n = 142; responders: n = 73 (51.4%); QALYs = 0.364, standard error (SE) = 0.006] or without guidance [n = 146; n = 66 (45.2%); 0.359, 0.007]. Controls were on a waiting-list [n = 144; n = 38 (26.4%); 0.342, 0.007]. 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.