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.

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.

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).

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

Personalised depression forecasting using mobile sensor data and ecological momentary assessment.

Introduction: Digital health interventions are an effective way to treat depression, but it is still largely unclear how patients' individual symptoms evolve dynamically during such treatments. Data-driven forecasts of depressive symptoms would allow to greatly improve the personalisation of treatments. In current forecasting approaches, models are often trained on an entire population, resulting in a general model that works overall, but does not translate well to each individual in clinically heterogeneous, real-world populations. Model fairness across patient subgroups is also frequently overlooked. Personalised models tailored to the individual patient may therefore be promising. Methods: We investigate different personalisation strategies using transfer learning, subgroup models, as well as subject-dependent standardisation on a newly-collected, longitudinal dataset of depression patients undergoing treatment with a digital intervention ( N = 65 patients recruited). Both passive mobile sensor data as well as ecological momentary assessments were available for modelling. We evaluated the models' ability to predict symptoms of depression (Patient Health Questionnaire-2; PHQ-2) at the end of each day, and to forecast symptoms of the next day. Results: In our experiments, we achieve a best mean-absolute-error (MAE) of 0.801 (25% improvement) for predicting PHQ-2 values at the end of the day with subject-dependent standardisation compared to a non-personalised baseline ( MAE = 1.062 ). For one day ahead-forecasting, we can improve the baseline of 1.539 by 12 % to a MAE of 1.349 using a transfer learning approach with shared common layers. In addition, personalisation leads to fairer models at group-level. Discussion: Our results suggest that personalisation using subject-dependent standardisation and transfer learning can improve predictions and forecasts, respectively, of depressive symptoms in participants of a digital depression intervention. We discuss technical and clinical limitations of this approach, avenues for future investigations, and how personalised machine learning architectures may be implemented to improve existing digital interventions for depression.

Journaling Data for Daily PHQ-2 Depression Prediction and Forecasting.

Digital health applications are becoming increasingly important for assessing and monitoring the wellbeing of people suffering from mental health conditions like depression. A common target of said applications is to predict the results of self-assessed Patient-Health-Questionnaires (PHQ), indicating current symptom severity of depressive individuals. Many of the currently available approaches to predict PHQ scores use passive data, e.g., from smartphones. However, there are several other scores and data besides PHQ, e.g., the Behavioral Activation for Depression Scale-Short Form (BADSSF), the Center for Epidemiologic Studies Depression Scale (CESD), or the Personality Dynamics Diary (PDD), all of which can be effortlessly collected on a daily basis. In this work, we explore the potential of using actively-collected data to predict and forecast daily PHQ-2 scores on a newly-collected longitudinal dataset. We obtain a best MAE of 1.417 for daily prediction of PHQ-2 scores, which specifically in the used dataset have a range of 0 to 12, using leave-one-subject-out cross-validation, as well as a best MAE of 1.914 for forecasting PHQ-2 scores using data from up to the last 7 days. This illustrates the additive value that can be obtained by incorporating actively-collected data in a depression monitoring application.

Depression Diagnosis and Forecast based on Mobile Phone Sensor Data.

Previous studies have shown the correlation be-tween sensor data collected from mobile phones and human depression states. Compared to the traditional self-assessment questionnaires, the passive data collected from mobile phones is easier to access and less time-consuming. In particular, passive mobile phone data can be collected on a flexible time interval, thus detecting moment-by-moment psychological changes and helping achieve earlier interventions. Moreover, while previous studies mainly focused on depression diagnosis using mobile phone data, depression forecasting has not received sufficient attention. In this work, we extract four types of passive features from mobile phone data, including phone call, phone usage, user activity, and GPS features. We implement a long short-term memory (LSTM) network in a subject-independent 10-fold cross-validation setup to model both a diagnostic and a forecasting tasks. Experimental results show that the forecasting task achieves comparable results with the diagnostic task, which indicates the possibility of forecasting depression from mobile phone sensor data. Our model achieves an accuracy of 77.0 % for major depression forecasting (binary), an accuracy of 53.7 % for depression severity forecasting (5 classes), and a best RMSE score of 4.094 (PHQ-9, range from 0 to 27).

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.

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.

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.

Implementing a digital intervention for managing uncontrolled hypertension in Primary Care: a mixed methods process evaluation.

BACKGROUND: A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients' home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. METHODS: One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients' medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. RESULTS: Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. CONCLUSIONS: This mixed-methods process evaluation provided novel insights into practitioners' decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients' readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. TRIAL REGISTRATION: ( ISRCTN13790648 ). Registered 14 May 2015.

Developing a digital intervention for cancer survivors: an evidence-, theory- and person-based approach.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors' needs, including barriers and facilitators to intervention success. Review evidence (N = 49 papers) informed the intervention's Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews (N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers (N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

Economic Evaluation of an Internet-Based Stress Management Intervention Alongside a Randomized Controlled Trial.

BACKGROUND: Work-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant. OBJECTIVE: The aim of this study was to assess the cost-effectiveness of a guided iSMI for employees. METHODS: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000). RESULTS: When the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained. CONCLUSIONS: Offering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC. TRIAL REGISTRATION: German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1471-2458-13-655.

Web-Based Stress Management Program for University Students in Indonesia: Systematic Cultural Adaptation and Protocol for a Feasibility Study.

BACKGROUND: The number of university students experiencing stress is increasing, which often leads to adverse effects such as poor grades, academic probation, and emotional problems. Unfortunately, most of these problems remain untreated because of limited professional resources and fear of stigma. Several Web-based stress management interventions are now available for student populations, but these treatments are not yet available in Indonesia. To make treatment for stress more acceptable in Indonesia, a cultural adaptation process is needed, and part of the process is assessing the feasibility of the adapted intervention. OBJECTIVE: This paper describes the first two stages of a cultural adaptation process and the protocol of a feasibility study that will assess the acceptability of a culturally adapted stress management intervention for university students in Indonesia. METHODS: Focus group discussions with Indonesian university students were held, and input from Indonesian psychologists was gathered for developing the adapted intervention. A single-group feasibility study with a pre-post design will be conducted. We will recruit at minimum 50 university students who have an elevated level of stress (Depression, Anxiety, and Stress Scales-42 stress subscale score ≥15), identify themselves as being of Indonesian culture (eg, able to speak Bahasa Indonesia fluently), and are studying at a university in Indonesia. The primary endpoints of this study will be rates of participant satisfaction, system usability, dropout rates, and level of adherence. We will also use qualitative data to assess the adapted intervention more thoroughly. Secondary study endpoints will be quality of life, stress, anxiety, and depression levels. Feasibility parameters (eg, participant satisfaction, system usability, and level of adherence) will be summarized with descriptive statistics. Two-tailed paired within-group t tests will be used to analyze stress, anxiety, depression, and quality of life. RESULTS: The enrollment of pilot study is currently ongoing. First results are expected to be ready for analysis in the second half of 2019. The project was funded as part of a PhD trajectory in 2015 by the Indonesian Endowment Fund for Education. CONCLUSIONS: This is one of the first studies to assess the feasibility of a culturally adapted Web-based stress management intervention for university students in Indonesia. Strengths and limitations of the study are discussed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11493.

The German Version of the Perceived Stress Scale (PSS-10): Evaluation of Dimensionality, Validity, and Measurement Invariance With Exploratory and Confirmatory Bifactor Modeling.

The Perceived Stress Scale (PSS) is a popular instrument for measuring the degree to which individuals appraise situations in their lives as excessively uncontrollable and overloaded. Despite its widespread use (e.g., for evaluating intervention effects in stress management studies), there is still no agreement on its factor structure. Hence, the aim of the present study was to examine the dimensionality, measurement invariance (i.e., across gender, samples, and time), reliability, and validity of the PSS. Data from 11,939 German adults (73% women) were used to establish an exploratory bifactor model for the PSS with one general and two specific factors and to cross-validate this model in a confirmatory bifactor model. The model displayed strong measurement invariance across gender and was replicated in Study 2 in data derived from six randomized controlled trials investigating a web-based stress management training. In Study 2 (overall N = 1,862), we found strong temporal invariance. Also, our analyses of concurrent and predictive validity showed associations with depressive symptoms, anxiety, and insomnia severity for the three latent PSS factors. These results show the implications of the bifactor structure of the PSS that might be of consequence in empirical research.

Severely Burdened Individuals Do Not Need to Be Excluded From Internet-Based and Mobile-Based Stress Management: Effect Modifiers of Treatment Outcomes From Three Randomized Controlled Trials.

BACKGROUND: Although internet-based and mobile-based stress management interventions (iSMIs) may be a promising strategy to reach employees suffering from high chronic stress, it remains unknown whether participants with high symptom severity of depression or anxiety also benefit from iSMIs or should be excluded. OBJECTIVE: This study aimed to evaluate the efficacy of iSMIs in subgroups with high symptom severity and to test whether baseline symptom severity moderates treatment outcome. METHODS: Data from three randomized controlled trials (N=791) were pooled to identify effect modifiers and to evaluate efficacy in subgroups with different levels of initial symptom severity. The outcomes perceived stress (Perceived Stress Scale, PSS), depression severity (Center for Epidemiological Depression Scale, CES-D), and anxiety (Hospital Anxiety and Depression Scale, HADS) symptom severity were assessed at baseline, 7-week postassessment, and 6-month follow-up. Potential moderators were tested in predicting differences in the change of outcome in multiple moderation analyses. Simple slope analyses evaluated efficacy of the iSMI comparing the intervention group with the waitlist control group in subgroups with low, moderate, and severe initial symptomology based on means and SDs of the study population. In addition, subgroups with clinical values of depression (CES-D≥16) and anxiety (HADS≥8) at baseline were explored, and response rates (RRs; 50% symptom reduction) and symptom-free (SF) status (CES-D<16, HADS<8) were reported. RESULTS: Individuals with high stress (PSS≥30), depression (CES-D≥33), anxiety (HADS≥15), and emotional exhaustion (MBI≥5.6) benefited significantly from the intervention with great reductions of stress (dpost=0.86-1.16, dFU=0.93-1.35), depression (dpost=0.69-1.08, dFU=0.91-1.19), and anxiety (dpost=0.79-1.19, dFU=1.06-1.21), and effects were sustained at 6-month follow-up. Symptom severity moderated treatment outcomes, as individuals with higher symptom severity at baseline benefited significantly more from the intervention than individuals with lower symptom severity. Furthermore, 82.9% (656/791) of individuals had clinical depression values at baseline, of which significantly more individuals in the intervention group reached at least 50% symptom reduction or fell under clinical cut-off (RR: 29.2%, 93/318; SF: 39.6%, 126/318) compared with the waitlist control group (RR: 8.0%, 27/338; SF: 18.6%, 63/338) at postassessment. Significantly more individuals with clinical anxiety values at baseline (HADS≥8, 85.3%, 675/791) in the intervention group achieved at least 50% symptom reduction or fell under clinical cut-off (RR: 27.7%, 94/339; SF: 39.8%, 135/339) compared with the WLC (RR: 4.8%, 16/336; SF: 15.5%, 52/336). CONCLUSIONS: Highly burdened individuals benefit greatly from iSMIs and therefore should not be excluded from participation. Stress management may be a valid entry point to reach highly burdened individuals who otherwise may not seek treatment. TRIAL REGISTRATION: 1) German Clinical Trials Register DRKS00005112; https://www.drks.de/DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6zmIZwvdA); 2) German Clinical Trials Register DRKS00005384; https://www.drks.de/ DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6zmIerdtr); and 3) German Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6zmIjDQPx).

A health economic outcome evaluation of an internet-based mobile-supported stress management intervention for employees.

Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internet- and mobile-supported occupational stress-management intervention (iSMI) for employees from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of EUR181 [95% confidence interval (CI) -6043-1042] per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of EUR0, EUR1000, EUR2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.

The Benefit of Web- and Computer-Based Interventions for Stress: A Systematic Review and Meta-Analysis.

BACKGROUND: Stress has been identified as one of the major public health issues in this century. New technologies offer opportunities to provide effective psychological interventions on a large scale. OBJECTIVE: The aim of this study is to investigate the efficacy of Web- and computer-based stress-management interventions in adults relative to a control group. METHODS: A meta-analysis was performed, including 26 comparisons (n=4226). Cohen d was calculated for the primary outcome level of stress to determine the difference between the intervention and control groups at posttest. Analyses of the effect on depression, anxiety, and stress in the following subgroups were also conducted: risk of bias, theoretical basis, guidance, and length of the intervention. Available follow-up data (1-3 months, 4-6 months) were assessed for the primary outcome stress. RESULTS: The overall mean effect size for stress at posttest was Cohen d=0.43 (95% CI 0.31-0.54). Significant, small effects were found for depression (Cohen d=0.34, 95% CI 0.21-0.48) and anxiety (Cohen d=0.32, 95% CI 0.17-0.47). Subgroup analyses revealed that guided interventions (Cohen d=0.64, 95% CI 0.50-0.79) were more effective than unguided interventions (Cohen d=0.33, 95% CI 0.20-0.46; P=.002). With regard to the length of the intervention, short interventions (≤4 weeks) showed a small effect size (Cohen d=0.33, 95% CI 0.22-0.44) and medium-long interventions (5-8 weeks) were moderately effective (Cohen d=0.59; 95% CI 0.45-0.74), whereas long interventions (≥9 weeks) produced a nonsignificant effect (Cohen d=0.21, 95% CI -0.05 to 0.47; P=.006). In terms of treatment type, interventions based on cognitive behavioral therapy (CBT) and third-wave CBT (TWC) showed small-to-moderate effect sizes (CBT: Cohen d=0.40, 95% CI 0.19-0.61; TWC: Cohen d=0.53, 95% CI 0.35-0.71), and alternative interventions produced a small effect size (Cohen d=0.24, 95% CI 0.12-0.36; P=.03). Early evidence on follow-up data indicates that Web- and computer-based stress-management interventions can sustain their effects in terms of stress reduction in a small-to-moderate range up to 6 months. CONCLUSIONS: These results provide evidence that Web- and computer-based stress-management interventions can be effective and have the potential to reduce stress-related mental health problems on a large scale.

Internet- and mobile-based stress management for employees with adherence-focused guidance: efficacy and mechanism of change.

OBJECTIVE: This randomized controlled trial (RCT) aimed to evaluate the efficacy of an internet-based stress management intervention (iSMI) among employees compared to a 6-month waitlist control group (WLC) with full access to treatment-as-usual. METHOD: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was assigned to either the iSMI or WLC group. The iSMI consisted of seven sessions and one booster session including problem-solving and emotion regulation techniques. Participants received guidance from an e-coach that focused on improving the adherence to the intervention. Self-report data were assessed at baseline, seven weeks, and six months following randomization. The primary outcome was perceived stress (PSS-10). The secondary outcomes included other relevant mental and work-related health outcomes. RESULTS: The iSMI participants showed a significantly higher reduction in perceived stress from baseline to seven weeks [d=0.79, 95% confidence interval (95% CI) 0.54-1.04] and the 6-month follow up (d=0.85, 95% CI 0.59-1.10) compared to controls. Significant moderate-to-large effect sizes were also found for depression, anxiety, emotional exhaustion, sleeping problems, worrying, quality of life (mental health), psychological detachment and emotion regulation skills. Work engagement, quality of life (physical health), absenteeism and presenteeism were not found to significantly differ between the iSMI and WLC groups. Changes in emotion regulation regarding general distress mediated changes in perceived stress. CONCLUSION: The iSMI investigated in this study was found to be effective in reducing typical symptoms of stress. However, several important work-related health symptoms were not significantly affected by the intervention. Internet-based guided self-help interventions could be an acceptable, effective approach to reduce a range of negative consequences associated with work-related stress. Future studies should investigate the comparative (cost-) effectiveness of guided and unguided stress management interventions.