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.

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.

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).

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.

Self-guided internet-based and mobile-based stress management for employees: results of a randomised controlled trial.

OBJECTIVE: This randomised controlled trial (RCT) aimed to evaluate the efficacy of a self-guided internet-based stress management intervention (iSMI) for employees compared to a 6-month wait-list control group (WLC) with full access for both groups to treatment as usual. METHOD: A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned to either the iSMI or to the WLC. The iSMI consisted of seven sessions and one booster session including problem-solving and emotion regulation techniques. Self-report data were assessed at baseline, at 7 weeks and at 6 months following randomisation. The primary outcome was perceived stress (PSS-10). The secondary outcomes included other relevant mental-related and work-related health outcomes. Data were analysed based on intention-to-treat principles. RESULTS: The iSMI participants showed a significantly higher reduction in perceived stress from baseline to post-treatment at 7 weeks (d=0.96, 95% CI 0.70 to 1.21) and to the 6-month follow-up (d=0.65, 95% CI 0.40 to 0.89) compared to the WLC. Significant differences with small to moderate effect sizes were also found for depression, anxiety, emotional exhaustion, sleeping problems, worrying, mental health-related quality of life, psychological detachment, emotion regulation skills and presenteeism, in favour of the experimental group. At the 6 -month follow-up, all outcomes remained significantly better for the experimental group with the exception of work engagement, physical health-related quality of life and absenteeism, which were not found to significantly differ between the iSMI and WLC groups. CONCLUSIONS: The iSMI investigated in this study was found to be effective in reducing typical mental-related and work-related health symptoms of stressed employees. Internet-based self-guided interventions could be an acceptable, effective and potentially cost-effective approach to reduce the negative consequences associated with work-related stress.

Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial.

BACKGROUND: Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. OBJECTIVE: This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. METHODS: A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus's transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. RESULTS: An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F1,261=58.08, P<.001; Cohen's d=0.83) and at the 6-month follow-up (F1,261=80.17, P<.001; Cohen's d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. CONCLUSIONS: This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): 00004749; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do (Archived by WebCite at http://www.webcitation.org/6e8rl98nl).

Efficacy and cost-effectiveness of minimal guided and unguided internet-based mobile supported stress-management in employees with occupational stress: a three-armed randomised controlled trial.

BACKGROUND: Internet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress. METHODS: A three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer's perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation. DISCUSSION: Online-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00005687.

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).

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.

Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: design of a randomised controlled trial.

BACKGROUND: A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms. METHODS/DESIGN: A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective. DISCUSSION: If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes. TRIAL REGISTRATION: German Clinical Trial Register (DRKS): DRKS00004748.

Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial.

BACKGROUND: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees. METHODS: The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-ß of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol. DISCUSSION: The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed. TRIAL REGISTRATION: German Register of Clinical Studies (DRKS): DRKS00004749.

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.

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.

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.

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.

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.