Efficacy of an Internet- and Mobile-Based Intervention for Subclinical Anxiety and Depression (ICare Prevent) with Two Guidance Formats: Results from a Three-Armed Randomized Controlled Trial.

INTRODUCTION: Limited research exists on intervention efficacy for comorbid subclinical anxiety and depressive disorders, despite their common co-occurrence. Internet- and mobile-based interventions (IMIs) are promising to reach individuals facing subclinical symptoms. OBJECTIVE: This study aimed to evaluate the efficacy of a transdiagnostic and self-tailored IMI in reducing subclinical anxiety and depressive symptom severity with either individualized (IG-IMI) or automated (AG-IMI) guidance compared to a waitlist control group with care-as-usual access (WLC). METHODS: Participants included 566 adults with subclinical anxiety (GAD-7 ≥ 5) and/or depressive (CES-D ≥16) symptoms, who did not meet criteria for a full-syndrome depressive or anxiety disorder. In a three-arm randomized clinical trial, participants were randomized to a cognitive behavioral 7-session IMI plus booster session with IG-IMI (n = 186) or AG-IMI (n = 189) or WLC (n = 191). Primary outcomes included observer-rated anxiety (HAM-A) and depressive (QIDS) symptom severity 8 weeks after randomization assessed by blinded raters via telephone. Follow-up outcomes at 6 and 12 months are reported. RESULTS: Symptom severity was significantly lower with small to medium effects in IG-IMI (anxiety: d = 0.45, depression: d = 0.43) and AG-IMI (anxiety: d = 0.31, depression: d = 0.32) compared to WLC. No significant differences emerged between guidance formats in primary outcomes. There was a significant effect in HAM-A after 6 months favoring AG-IMI. On average, participants completed 85.38% of IG-IMI and 77.38% of AG-IMI. CONCLUSIONS: A transdiagnostic, self-tailored IMI can reduce subclinical anxiety and depressive symptom severity, but 12-month long-term effects were absent. Automated guidance holds promise for enhancing the scalability of IMIs in broad prevention initiatives.

A Universal Digital Stress Management Intervention for Employees: Randomized Controlled Trial with Health-Economic Evaluation.

BACKGROUND: Stress is highly prevalent and known to be a risk factor for a wide range of physical and mental disorders. The effectiveness of digital stress management interventions has been confirmed; however, research on its economic merits is still limited. OBJECTIVE: This study aims to assess the cost-effectiveness, cost-utility, and cost-benefit of a universal digital stress management intervention for employees compared with a waitlist control condition within a time horizon of 6 months. METHODS: Recruitment was directed at the German working population. A sample of 396 employees was randomly assigned to the intervention group (n=198) or the waitlist control condition (WLC) group (n=198). The digital stress management intervention included 7 sessions plus 1 booster session, which was offered without therapeutic guidance. Health service use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and an employer's perspective. Costs were related to symptom-free status (PSS-10 [Perceived Stress Scale] score 2 SDs below the study population baseline mean) and quality-adjusted life years (QALYs) gained. The sampling error was handled using nonparametric bootstrapping. RESULTS: From a societal perspective, the digital intervention was likely to be dominant compared with WLC, with a 56% probability of being cost-effective at a willingness-to-pay (WTP) of €0 per symptom-free person gained. At the same WTP threshold, the digital intervention had a probability of 55% being cost-effective per QALY gained relative to the WLC. This probability increased to 80% at a societal WTP of €20,000 per QALY gained. Taking the employer's perspective, the digital intervention showed a probability of a positive return on investment of 78%. CONCLUSIONS: Digital preventive stress management for employees appears to be cost-effective societally and provides a favorable return on investment for employers. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005699; https://drks.de/search/en/trial/DRKS00005699.

Challenges in Recruiting University Students for Web-Based Indicated Prevention of Depression and Anxiety: Results From a Randomized Controlled Trial (ICare Prevent).

BACKGROUND: Depression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students' desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations. OBJECTIVE: The aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention's effectiveness. METHODS: A 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students' use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size. RESULTS: Direct recruitment through students' email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7). CONCLUSIONS: This report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials. TRIAL REGISTRATION: International Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2477-y.

Psychological interventions to improve sleep in college students: A meta-analysis of randomized controlled trials.

Sleep disturbances and insomnia are common in college students, and reduce their quality of life and academic performance. The aim of this meta-analysis was to evaluate the efficacy of psychological interventions aimed at improving sleep in college students. A meta-analysis was conducted with 10 randomized controlled trials with passive control conditions (N = 2,408). The overall mean effect size (Hedges' g) of all sleep-related outcomes within each trial was moderate to large (g = 0.61; 95% confidence interval: 0.41-0.81; numbers-needed-to-treat = 3). Effect sizes for global measures of sleep disturbances were g = 0.79; 95% confidence interval: 0.52-1.06; and for sleep-onset latency g = 0.65; 95% confidence interval: 0.36-0.94. The follow-up analyses revealed an effect size of g = 0.56; 95% confidence interval: 0.45-0.66 for the combined sleep-related outcomes based on three studies. No significant covariates were identified. These results should be interpreted cautiously due to an overall substantial risk of bias, and in particular with regard to blinding of participants and personnel. Nevertheless, they provide evidence that psychological interventions for improving sleep are efficacious among college students. Further research should explore long-term effects and potential moderators of treatment efficacy in college students.

Stakeholders' views on online interventions to prevent common mental health disorders in adults implemented into existing healthcare systems in Europe.

BACKGROUND: Online preventive interventions can help to reduce the incidence of mental disorders. Whereas knowledge on stakeholders' attitudes and factors relevant for successfully integrating online treatment into existing healthcare systems is available, knowledge is scarce for online prevention. METHODS: Stakeholders from Germany, Switzerland, Austria and Spain were surveyed. Potential facilitators/delivery staff (e.g. psychologists, psychotherapists) completed an online questionnaire (n = 183), policy makers (i.e. from the governing sector or health insurance providers) participated in semi-structured interviews (n = 16) and target groups/potential users of mental illness prevention (n = 49) participated in ten focus groups. Thematic analysis was used to identify their experiences with and attitudes and needs regarding online programmes to prevent mental disorders. Additionally, it was examined which groups they consider underserved and which factors they consider as fostering and hindering for reach, adoption, implementation and maintenance (cf. RE-AIM model) when integrating online prevention into existing healthcare systems. RESULTS: Main advantages of online mental illness prevention are perceived in low structural and psychological barriers. Lack of personal contact, security, privacy and trust concerns were discussed as disadvantages. Relevant needs are high usability and target group appropriateness, evidence for effectiveness and the use of motivational tools. CONCLUSIONS: Positive attitudes among stakeholders are the key for successful integration of online mental illness prevention into existing healthcare systems. Potential facilitators/delivery staff must receive training and support to implement these programmes; the programmes must be attractive and continuously evaluated, updated and promoted to ensure ongoing reach; and existing infrastructure and contextual factors must be considered.

Online prevention programmes for university students: stakeholder perspectives from six European countries.

BACKGROUND: Students beginning university are at a heightened risk for developing mental health disorders. Online prevention and early intervention programmes targeting mental health have the potential to reduce this risk, however, previous research has shown uptake to be rather poor. Understanding university stakeholders' (e.g. governing level and delivery staff [DS] and students) views and attitudes towards such online prevention programmes could help with their development, implementation and dissemination within university settings. METHODS: Semi-structured interviews, focus groups and online surveys were completed with staff at a governing level, university students and DS (i.e. student health or teaching staff) from six European countries. They were asked about their experiences with, and needs and attitudes towards, online prevention programmes, as well as the factors that influence the translation of these programmes into real-world settings. Results were analyzed using thematic analysis. RESULTS: Participating stakeholders knew little about online prevention programmes for university settings; however, they viewed them as acceptable. The main themes to emerge were the basic conditions and content of the programmes, the awareness and engagement, the resources needed, the usability and the responsibility and ongoing efforts to increase reach. CONCLUSIONS: Overall, although these stakeholders had little knowledge about online prevention programmes, they were open to the idea of introducing them. They could see the potential benefits that these programmes might bring to a university setting as a whole and the individual students and staff members.

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

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

User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study.

BACKGROUND: Internet interventions have been shown to be effective in treating anxiety disorders. Most interventions to date focus on single disorders and disregard potential comorbidities. OBJECTIVE: The aim of this mixed-methods study was to investigate feasibility, user experience, and effects of a newly developed individually tailored transdiagnostic guided internet intervention for anxiety disorders. METHODS: This study is an uncontrolled, within-group, baseline, postintervention pilot trial with an embedded qualitative and quantitative process and effect evaluation. In total, 49 adults with anxiety disorders (generalized anxiety disorder n=20, social phobia n=19, agoraphobia without panic n=12, panic with agoraphobia n=6, panic without agoraphobia n=4, subclinical depression n=41) received access to the 7-session intervention. We examined motivation and expectations, intervention use, user experience, impact, and modification requests. Qualitative data were assessed using semistructured interviews and analyzed by qualitative content analysis. Quantitative outcomes included symptom severity of anxiety and depression (Hamilton Anxiety Rating Scale [HAM-A], Quick Item Inventory of Depressive Symptomatology clinician rating [QIDS-C]), diagnostic status in clinical interviews (Mini International Neuropsychiatric Interview [MINI]), and web-based self-reports (Generalized Anxiety Disorder-7 [GAD-7], Center for Epidemiological Studies Depression Scale [CES-D], Beck Anxiety Inventory [BAI], Panic and Agoraphobia Scale [PAS], Social Phobia Scale [SPS], Patient Health Questionnaire-9 [PHQ-9]) at baseline and postassessment. Quantitative data was analyzed by comparing within-group means expressed as Cohen d. RESULTS: Anxiety symptom severity (HAM-A d=1.19) and depressive symptoms (QIDS-C d=0.42) improved significantly, and 54% (21/39) no longer were diagnosed as having any anxiety disorder. The main positive effects were the general improvement of disease burden and attentiveness to feelings and risk situations while the main negative effects experienced were lack of change in disease burden and symptom deterioration. The most prevalent reasons for participation were the advantages of online treatment, symptom burden, and openness toward online treatment. Helpful factors included support, psychoeducation and practicing strategies in daily life; the main hindering factors were too little individualization and being overwhelmed by the content and pace. CONCLUSIONS: The intervention was found to be feasible and results show preliminary data indicating potential efficacy for improving anxiety and depression. The next step should be the evaluation within a randomized controlled trial. Concerning intervention development, it was found that future interventions should emphasize individualization even more in order to further improve the fit to individual characteristics, preferences, and needs.

Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards.

BACKGROUND: Adherence reflects the extent to which individuals experience or engage with the content of online interventions and poses a major challenge. Neglecting to examine and report adherence and its relation to outcomes can compromise the interpretation of research findings. OBJECTIVE: The aim of this systematic review is to analyze how adherence is accounted for in publications and to propose standards for measuring and reporting adherence to online interventions. METHODS: We performed a systematic review of randomized controlled trials on online interventions for the prevention and treatment of common mental disorders (depression, anxiety disorders, substance related disorders, and eating disorders) published between January 2006 and May 2018 and indexed in Medline and Web of Science. We included primary publications on manualized online treatments (more than 1 session and successive access to content) and examined how adherence was reported in these publications. RESULTS: We identified 216 publications that met our inclusion criteria. Adherence was addressed in 85% of full-text manuscripts, but only in 31% of abstracts. A median of three usage metrics were reported; the most frequently reported usage metric (61%) was intervention completion. Manuscripts published in specialized electronic health journals more frequently included information on the relation of adherence and outcomes. CONCLUSIONS: We found substantial variety in the reporting of adherence and the usage metrics used to operationalize adherence. This limits the comparability of results and impedes the integration of findings from different studies. Based on our findings, we propose reporting standards for future publications on online interventions.

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).

Turning Good Intentions Into Actions by Using the Health Action Process Approach to Predict Adherence to Internet-Based Depression Prevention: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Many individuals engaging in Internet-based interventions fail to complete these treatments as intended. The processes responsible for treatment adherence in Internet-based interventions are still poorly understood. OBJECTIVE: The aim of this study was to investigate to what extent adherence in an Internet-based intervention can be predicted by motivational and volitional factors outlined in the health action process approach (HAPA). METHODS: This study investigated motivational and volitional factors included in HAPA in a randomized controlled trial to predict treatment adherence of N=101 individuals with subclinical depression in the intervention group of a depression prevention intervention (GET.ON Mood Enhancer). Adherence was operationalized as the number of completed treatment modules. Using longitudinal structural equation modeling, HAPA variables (motivational, maintenance, and recovery self-efficacy, outcome expectancies, intention, and planning) were assessed at baseline and their associations with adherence 7 weeks later. RESULTS: Planning predicted adherence. Better planning was, in turn, associated with higher levels of maintenance self-efficacy, and the latter significantly affected treatment adherence via planning. The other hypothesized direct associations were not significant. In total, the HAPA variables accounted for 14% of variance in treatment adherence. CONCLUSIONS: Planning emerged as the strongest predictor of treatment adherence in highly motivated participants in an Internet-based intervention out of all HAPA variables investigated. Findings are in line with the hypothesis that planning facilitates the translation of good intentions into actions. The findings imply that systematically fostering planning skills and maintenance self-efficacy prior to or during Internet-based interventions would help participants to successfully complete these treatments. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005973; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00005973 (Archived by WebCite at http://www.webcitation.org/6uxCy64sy).

Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

INTRODUCTION: Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. AIM: To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. METHODS: Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. MAIN OUTCOME MEASURES: The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. RESULTS: More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ21 = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. CONCLUSION: This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average duration of 6 years. Internet-based interventions could be a treatment modality to complement other methods in stepped care for vaginal penetration difficulties.

Adherence to Internet-Based Mobile-Supported Stress Management: A Pooled Analysis of Individual Participant Data From Three Randomized Controlled Trials.

BACKGROUND: Nonadherence to treatment is a prevalent issue in Internet interventions. Guidance from health care professionals has been found to increase treatment adherence rates in Internet interventions for a range of physical and mental disorders. Evaluating different guidance formats of varying intensity is important, particularly with respect to improvement of effectiveness and cost-effectiveness. Identifying predictors of nonadherence allows for the opportunity to better adapt Internet interventions to the needs of participants especially at risk for discontinuing treatment. OBJECTIVE: The goal of this study was to investigate the influence of different guidance formats (content-focused guidance, adherence-focused guidance, and administrative guidance) on adherence and to identify predictors of nonadherence in an Internet-based mobile-supported stress management intervention (ie, GET.ON Stress) for employees. METHODS: The data from the groups who received the intervention were pooled from three randomized controlled trials (RCTs) that evaluated the efficacy of the same Internet-based mobile-supported stress management intervention (N=395). The RCTs only differed in terms of the guidance format (content-focused guidance vs waitlist control, adherence-focused guidance vs waitlist control, administrative guidance vs waitlist control). Adherence was defined by the number of completed treatment modules (0-7). An ANOVA was performed to compare the adherence rates from the different guidance formats. Multiple hierarchical linear regression analysis was conducted to evaluate predictors of nonadherence, which included gender, age, education, symptom-related factors, and hope for improvement. RESULTS: In all, 70.5% (93/132) of the content-focused guidance sample, 68.9% (91/132) of the adherence-focused guidance sample, and 42.0% (55/131) of the participants in the administrative guidance sample completed all treatment modules. Guidance had a significant effect on treatment adherence (F2,392=11.64, P<.001; ω(2)=.05). Participants in the content-focused guidance (mean 5.70, SD 2.32) and adherence-focused guidance samples (mean 5.58, SD 2.33) completed significantly more modules than participants in the administrative guidance sample (mean 4.36, SD 2.78; t223=4.53, P<.001; r=.29). Content-focused guidance was not significantly associated with higher adherence compared to adherence-focused guidance (t262=0.42, P=.67; r=.03). The effect size of r=.03 (95% CI -0.09 to 0.15) did not pass the equivalence margin of r=.20 and the upper bound of the 95% CI lay below the predefined margin, indicating equivalence between adherence-focused guidance and content-focused guidance. Beyond the influence of guidance, none of the predictors significantly predicted nonadherence. CONCLUSIONS: Guidance has been shown to be an influential factor in promoting adherence to an Internet-based mobile-supported stress management intervention. Adherence-focused guidance, which included email reminders and feedback on demand, was equivalent to content-focused guidance with regular feedback while requiring only approximately a quarter of the coaching resources. This could be a promising discovery in terms of cost-effectiveness. However, even after considering guidance, sociodemographic, and symptom-related characteristics, most interindividual differences in nonadherence remain unexplained. CLINICAL TRIAL: DRKS00004749; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ID=DRKS00004749 (Archived by WebCite at http://www.webcitation.org/6QiDk9Zn8); DRKS00005112; http://drks-neu.uniklinik-freiburg. de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005112 (Archived by WebCite at http://www.webcitation.org/6QiDysvev); DRKS00005384; http://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005384 (Archived by WebCite at http://www.webcitation.org/6QiE0xcpE).

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.

Internet- and mobile-based psychological interventions for post-traumatic stress symptoms in youth: a systematic review and meta-analysis.

Psychological interventions can help reduce posttraumatic stress symptoms (PTSS) in youth, but many do not seek help. Internet- and mobile-based interventions (IMIs) show promise in expanding treatment options. However, the overall evidence on IMIs in reducing PTSS among youth remains unclear. This systematic review and meta-analysis investigated the efficacy of IMIs in PTSS reduction for youth exposed to traumatic events. A comprehensive literature search was conducted in January 2023 including non-randomized and randomized-controlled trials (RCT) investigating the effects of IMIs on PTSS in youth aged ≤25 years. Six studies were identified with five providing data for the meta-analysis. The majority of studies included youth with different types of trauma irrespective of PTSS severity at baseline (k = 5). We found a small within-group effect in reducing PTSS from baseline to post-treatment (g = -0.39, 95% CrI: -0.67 to -0.11, k = 5; n = 558; 9 comparisons). No effect emerged when comparing the effect of IMIs to control conditions (g = 0.04; 95%-CrI: -0.52 to 0.6, k = 3; n = 768; k = 3; 4 comparisons). Heterogeneity was low between and within studies. All studies showed at least some concerns in terms of risk of bias. Current evidence does not conclusively support the overall efficacy of IMIs in addressing youth PTSS. This review revealed a scarcity of studies investigating IMIs for youth exposed to traumatic events, with most being feasibility studies rather than adequately powered RCTs and lacking a trauma focus. This underscores the demand for more high-quality research.

Feasibility of a trauma-focused internet- and mobile-based intervention for youth with posttraumatic stress symptoms.

Background: Many youth with posttraumatic stress symptoms (PTSS) do not receive evidence-based care. Internet- and Mobile-Based Interventions (IMIs) comprising evidence-based trauma-focused components can address this gap, but research is scarce. Thus, we investigated the feasibility of a trauma-focused IMI for youth with PTSS.Methods: In a one-arm non-randomized prospective proof-of-concept study, 32 youths aged 15-21 years with clinically relevant PTSS (CATS ≥ 21) received access to a trauma-focused IMI with therapist guidance, comprising nine sessions on an eHealth platform accessible via web-browser. We used a feasibility framework assessing recruitment capability, sample characteristics, data collection, satisfaction, acceptability, study management abilities, safety aspects, and efficacy of the IMI in PTSS severity and related outcomes. Self-rated assessments took place pre-, mid-, post-intervention and at 3-month follow-up and clinician-rated assessments at baseline and post-intervention.Results: The sample mainly consisted of young adult females with interpersonal trauma and high PTSS levels (CATS, M = 31.63, SD = 7.64). The IMI sessions were found useful and comprehensible, whereas feasibility of trauma processing was perceived as difficult. Around one-third of participants (31%) completed the IMI's eight core sessions. The study completer analysis showed a significant reduction with large effects in self-rated PTSS at post-treatment [t(21) = 4.27; p < .001; d = 0.88] and follow-up [t(18) = 3.83; p = .001; d = 0.84], and clinician-rated PTSD severity at post-treatment [t(21) = 4.52; p < .001; d = 0.93]. The intention-to-treat analysis indicated significant reductions for PTSS at post-treatment and follow-up with large effect sizes (d = -0.97- -1.02). All participants experienced at least one negative effect, with the most common being the resurfacing of unpleasant memories (n = 17/22, 77%).Conclusion: The study reached highly burdened young adults. The IMI was accepted in terms of usefulness and comprehensibility but many youths did not complete all sessions. Exploration of strategies to improve adherence in trauma-focused IMIs for youth is warranted, alongside the evaluation of the IMI's efficacy in a subsequent randomized controlled trial.

Youth often lack access to evidence-based care after trauma. This study assessed the feasibility of a trauma-focused internet- and mobile-based intervention with therapist guidance.The intervention was accepted by youths, and the preliminary evaluation of participant responses suggests its efficacy.Future studies should examine strategies to improve adherence and the IMI's efficacy in a RCT.

A systematic review of predictors and moderators of treatment outcomes in internet- and mobile-based interventions for depression.

This systematic review aimed to synthesize evidence on predictors and moderators of treatment outcomes in internet- and mobile-based interventions (IMIs) for depression, informing personalized care. A systematic search across PubMed, PsycInfo, and Cochrane yielded 33,002 results. Two reviewers independently performed screening, data extraction, risk of bias assessment, and methodological quality evaluation. Fifty-eight single studies (m = 466 analyses) focusing on baseline-predictors (59.7 %, m = 278), process-predictors (16.5 %, m = 77), and moderators (21.9 %, m = 102), and six individual patient data meta-analyses (m = 93) were included. Only 24.0 % (m = 112/466) of analyses in single studies and 15.1 % (m = 14/93) in individual patient data meta-analyses were significant. Evidence from single studies was rated as insufficient for all variable categories with only 2 out of 40 categories showing >50 % significant results. Baseline depression severity had the strongest predictive value with higher scores linked to better outcomes followed by variables indicative for the course-of-change. Other frequently analyzed and potentially relevant variables with significant results were adherence, age, educational level, ethnicity, relationship status, treatment history, and behavioral variables. More high quality quantitative studies with sufficient power are essential to validate and expand findings, identifying predictors and moderators specifically relevant in IMIs to explain differential treatment effects.

What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports.

Background: Despite severely burdened individuals, often being excluded from research studies on internet- and mobile-based interventions (IMIs), negative events (NEs) including suicidal thoughts and behaviors (STBs) can still occur during a trial. NEs require monitoring and adequate safety measures. However, study protocols frequently lack comprehensive descriptions of procedures for managing NEs. Aims: This study aimed to illustrate the assessment, monitoring, and procedures for addressing NEs in two studies on IMIs in adults and youth using case reports, to identify strengths and weaknesses of the NE management approaches, and to derive key learnings and recommendations. Methods: Two case reports were drawn from two distinct IMI studies. The first study, PSYCHOnlineTHERAPY, evaluates the combination of an IMI with on-site psychotherapy for anxiety and depressive disorders in adults (adult blended study). The second study evaluates a standalone, therapist-guided IMI for post-traumatic stress disorder (PTSD) in youth (youth standalone study). Potential NEs were predefined depending on the study sample. The case studies thoroughly document the systematic recording and ongoing monitoring of NEs through self-report and observer-based assessments during the interventions. The cases illustrate a variety of NE management strategies, including automated and personalized approaches, adapted to the specific nature and severity of the NEs. The NE management approaches are visualized using decision trees. Results: In the adult blended case study, online questionnaires detected STBs and triggered automated support information. As on-site therapy had already ended, a telephone consultation session allowed for the identification and discussion of the heightened intensity of suicidal thoughts, along with the development of specific additional help options. In the youth standalone case study, heightened tension in an adolescent with PTSD during trauma processing could be addressed in a telephone therapeutic session focusing on resource activation and emotion regulation. The referral to on-site treatment was supported. Overall, advantages of the NE management included automated procedures, multimodal assessment of a wide range of NEs, and standardized procedures tailored to different severity levels. Weaknesses included the use of single-item assessments for STBs and lack of procedures in case of deterioration or nonresponse to treatment. Conclusion: This study provides practical insights and derives key learnings and recommendations regarding the management of NEs in different IMI contexts for both adults and youth.

BEST FOR CAN - bringing empirically supported treatments to children and adolescents after child abuse and neglect: update to the study protocol.

Background: The implementation trial BESTFORCAN aims to evaluate the dissemination of Trauma-Focused Behavioural Therapy (TF-CBT) for children and adolescents in Germany with posttraumatic stress symptoms (PTSS) after child abuse and neglect (CAN) with a focus on supervision.Objective: This update to the study protocol outlines changes made due to practical reasons in the course of the ongoing trial while maintaining methodological quality.Method: The amendments to the original study protocol comprise (1) a more refined operationalisation of the primary outcome sufficiently adherent TF-CBT therapy (SATT), (2) changes in the study sites and (3) additional inclusion of one post-gradual psychotherapy training institute.Discussion: The adaptions to the original study protocol ensured high methodological quality through the transparent presentation of protocol modification: ensuring the recruitment of participating psychotherapists in training by including a further post-gradual training institute as well as an adaption of the measurement of SATT with high external validity. The objectives, diagnostic set, and secondary outcomes remained unimpaired by the amendment. Therefore, we expect the trial to provide evidence for the effect of model-specific trauma-focused supervision on the implementation outcomes of TF-CBT as compared to supervision as usual.Trial registration: German Clinical Trials Register identifier: DRKS00020516..

Update to the study protocol of the trial BESTFORCAN that investigates the implementation of trauma-focused behavioural therapy for children and adolescents with posttraumatic stress symptoms following abuse with a focus on the role of supervision.Adaptions have been made regarding the specification of the definition of sufficiently adherent intervention, relocation of the data-handling centre and the recruitment of one additional psychotherapy institute.The adaptions have no impact on the objectives, diagnostic set, secondary outcomes, or processes of data handling.

Case report for an internet- and mobile-based intervention for internet use disorder.

Background and aims: Internet use disorder (IUD), characterized as the inability to control one's internet use, is associated with reduced quality of life and mental health comorbidities such as depression, substance abuse, or anxiety. Evidence-based treatment options are scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions (IMI) may be an effective means to deliver psychological treatment to individuals with IUD as they address affected individuals in their online setting. This study presents a newly developed IMI for IUD disclosing treatment satisfaction and preliminary effects by exemplifying with a case report. Methods: The case of a female participant with IUD, characterized by an excessive use of social media, is analyzed. The case report follows the CARE guidelines and presents qualitative and quantitative outcomes regarding potential symptom reduction measured by the Internet Addiction Test (IAT) and Compulsive Internet Use Scale (CIUS), treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ) and feasibility by analyzing participant's written feedback during treatment. Results: The case report shows that internet- and mobile-based interventions may be feasible in supporting an individual in reducing symptoms of IUD as well as depressive symptoms, anxiety and procrastination behavior. Treatment satisfaction was reported as good. Discussion and conclusions: This case report illustrates that IMIs can have the potential to be an easily accessible and possibly effective treatment option for IUD. Case studies on IMIs may provide insights into important mechanisms for symptom change. Further studies are needed to expand our understanding of this diverse disorder to provide adequate treatment. Clinical Trial Registration: https://clinicaltrials.gov/,DRKS00015314.