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

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

Interpersonal factors in internet-based cognitive behavioral therapy for depression: Attachment style and alliance with the program and with the therapist.

Objective This open-trial study examined effects of a culturally-adapted Hebrew version of guided internet-based cognitive behavioural therapy (ICBT) for depression. We examined therapeutic alliance with the therapist and with the programme (content) as potential predictors of outcomes. Furthermore, we examined whether anxious and avoidant attachment styles improved, although relationships were not the focus of treatment. Method: We examined alliance with therapist and alliance with programme and their time-lagged (1 week), longitudinal relationship with depression outcomes, and change in anxious and avoidant attachment during treatment. Results: Depression and insomnia improved significantly (Cohen's d: depression = 1.34, insomnia = 0.86), though dropout was relatively high (49%). Alliance with programme and with the therapist predicted adherence and dropout, whereas only alliance with therapist predicted symptom improvement. Avoidant attachment decreased over treatment whereas anxious attachment did not. Conclusion: A culturally-adapted version of ICBT for depression showed that alliance with therapist and alliance with programme both can play an important role in its effectiveness: alliance with programme and the therapist drive adherence and dropout and alliance with therapist is related to symptom improvement. Although the focus of treatment is not interpersonal, avoidant attachment style can improve following ICBT.

Clinical and cognitive insight in panic disorder: phenomenology and treatment effects in internet cognitive behavior therapy.

Clinical observations suggest that individuals with panic disorder (PD) vary in their beliefs about the causes of their panic attacks. Some attribute these attacks to psychological factors, while others to physiological or medical factors. These beliefs also extend to whether individuals perceive panic attacks as dangerous. In other areas of psychiatric nosology, these phenomena are commonly called clinical insight (recognition of disorder and the need for treatment) and cognitive insight (the ability to reflect on one's beliefs). Despite its importance, limited research exists on insight in PD and its relation to symptoms and treatment outcomes. This study examines clinical and cognitive insight in 83 patients with PD who received internet-based cognitive behavioral therapy, investigating their relationship with symptoms, treatment outcomes, and changes in insight. We assessed patients using interview and self-report measures of insight and symptoms. Clinical and cognitive insight were correlated and both constructs improved significantly during treatment. Good clinical insight pretreatment was positively correlated with more severe pretreatment symptoms. Pretreatment clinical and cognitive insight were not correlated with symptom change or attrition. Greater change in clinical and cognitive insight was related to greater change in symptoms. The findings highlight the significance of clinical and cognitive insight in PD, and the importance of distinguishing between them. This suggests the need to develop interventions according to patients' level of insight, particularly focusing on those lacking insight. Further research is essential to advance our understanding of the relationship between insight and the phenomenology and treatment of PD.

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

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

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

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

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).

Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing.

BACKGROUND: Implementing evidence-based healthcare practices (EBPs) is a complex endeavour and often lags behind research-informed decision processes. Understanding and systematically improving implementation using implementation theory can help bridge the gap between research findings and practice. This study aims to translate, pilot, and validate a German version of the English NoMAD questionnaire (G-NoMAD), an instrument derived from the Normalisation Process Theory, to explore the implementation of EBPs. METHODS: Survey data has been collected in four German research projects and subsequently combined into a validation data set. Two versions of the G-NoMAD existed, independently translated from the original English version by two research groups. A measurement invariance analysis was conducted, comparing latent scale structures between groups of respondents to both versions. After determining the baseline model, the questionnaire was tested for different degrees of invariance (configural, metric, scalar, and uniqueness) across samples. A confirmatory factor analysis for three models (a four-factor, a unidimensional, and a hierarchical model) was used to examine the theoretical structure of the G-NoMAD. Finally, psychometric results were discussed in a consensus meeting, and the final instructions, items, and scale format were consented to. RESULTS: A total of 539 health care professionals completed the questionnaire. The results of the measurement invariance analysis showed configural, partial metric, and partial scalar invariance indicating that the questionnaire versions are comparable. Internal consistency ranged from acceptable to good (0.79 ≤ α ≤ 0.85) per subscale. Both the four factor and the hierarchical model achieved a better fit than the unidimensional model, with indices from acceptable (SRMR = 0.08) to good (CFI = 0.97; TLI = 0.96). However, the RMSEA values were only close to acceptable (four-factor model: χ2164 = 1029.84, RMSEA = 0.10; hierarchical model: χ2166 = 1073.43, RMSEA = 0.10). CONCLUSIONS: The G-NoMAD provides a reliable and promising tool to measure the degree of normalisation among individuals involved in implementation activities. Since the fit was similar in the four-factor and the hierarchical model, priority should be given to the practical relevance of the hierarchical model, including a total score and four subscale scores. The findings of this study support the further usage of the G-NoMAD in German implementation settings. TRIAL REGISTRATION: Both the AdAM project (No. NCT03430336, 06/02/2018) and the EU-project ImpleMentAll (No. NCT03652883, 29/08/2018) were registered on ClinicalTrials.gov. The ImplementIT study was registered at the German Clinical Trial Registration (No. DRKS00017078, 18/04/2019). The G-NoMAD validation study was registered at the Open Science Framework (No7u9ab, 17/04/2023).

An Online Mindfulness Intervention for International Students: A Randomized Controlled Feasibility Trial.

Background: Student mobility across borders poses challenges to health systems at the university and country levels. International students suffer from stress more than their local peers, however, do not seek help or underutilize existing help offers. Some barriers to help-seeking among international students are insufficient information regarding the health offers, stigma, and language, which might be overcome via culturally adapted internet and mobile-based interventions (IMI). Method: A randomized controlled feasibility trial with a parallel design assessed the feasibility and potential efficacy of an online mindfulness intervention adapted for international university students. Participants were randomized into either an adapted online mindfulness intervention (StudiCareM-E) (IG, n = 20) or a waitlist control group (WL, n = 20). Participants were assessed at baseline (t0) and eight-week post-randomization (t1). The feasibility of StudiCareM-E was evaluated regarding intervention adherence, client satisfaction, and potential negative effects. The potential efficacy of StudiCareM-E was measured by means of the level of mindfulness, perceived stress, depression, anxiety, presenteeism, and wellbeing. Efficacy outcomes were evaluated with regression models on the intention-to-treat (ITT) sample (n = 40), adjusting for the baseline values. Results: Participants' formative feedback suggested improvements in the content of the IMI. There were no crucial negative effects compared to WL. Assessment dropout was 35% (IG: 50%: WL: 20%), and intervention dropout was 60%. StudiCareM-E yielded significant improvements in mindfulness (ß = .34), well-being (ß = .37), and anxiety (ß = -.42) compared to WL. Conclusion: StudiCareM-E might be used among culturally diverse international student populations to improve their well-being. Future studies might carefully inspect the extent of the adaptation needs of their target group and design their interventions accordingly.

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.

Internet-Based Treatment of Body Dysmorphic Disorder: Feasibility, Evaluation, and Self-Report Data.

ABSTRACT: Initial findings indicate the effectiveness of internet-based interventions for body dysmorphic disorder (BDD). In order to substantiate these findings, a seven-module guided internet-based intervention was created and examined. We report the mixed data of participants with clinical and subclinical BDD of the treatment group (n = 18). We investigated the feasibility, the quality of the program content, the design and usability, and its effects on symptom severity and related psychopathology. Adherence to the intervention was low and dropout rate high (55.6%). The program content, perceived website usability, and visual aesthetic were rated high. Credibility and expectancy were on a medium level. Satisfaction with appearance improved significantly in the intention-to-treat analysis (d = 0.58). In sum, symptom-related outcomes and program evaluation showed a positive trend albeit the study conduction was difficult. Future programs should investigate the role of additional motivation strategies and more flexible support addressing the known treatment barriers.

Predicting heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain: Secondary analysis of two randomized controlled trials.

Background: Depression is highly prevalent among individuals with chronic back pain. Internet-based interventions can be effective in treating and preventing depression in this patient group, but it is unclear who benefits most from this intervention format. Method: In an analysis of two randomized trials (N = 504), we explored ways to predict heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain. Univariate treatment-moderator interactions were explored in a first step. Multilevel model-based recursive partitioning was then applied to develop a decision tree model predicting individualized treatment benefits. Results: The average effect on depressive symptoms was d = -0.43 (95 % CI: -0.68 to -0.17; 9 weeks; PHQ-9). Using univariate models, only back pain medication intake was detected as an effect moderator, predicting higher effects. More complex interactions were found using recursive partitioning, resulting in a final decision tree with six terminal nodes. The model explained a large amount of variation (bootstrap-bias-corrected R2 = 45 %), with predicted subgroup-conditional effects ranging from di = 0.24 to -1.31. External validation in a pilot trial among patients on sick leave (N = 76; R2 = 33 %) pointed to the transportability of the model. Conclusions: The studied intervention is effective in reducing depressive symptoms, but not among all chronic back pain patients. Predictions of the multivariate tree learning model suggest a pattern in which patients with moderate depression and relatively low pain self-efficacy benefit most, while no benefits arise when patients' self-efficacy is already high. If corroborated in further studies, the developed tree algorithm could serve as a practical decision-making tool.

Moderators and mediators of change of an internet-based mindfulness intervention for college students: secondary analysis from a randomized controlled trial.

Background: Existing evidence suggests internet- and mobile-based interventions (IMIs) improve depressive symptoms in college students effectively. However, there is far less knowledge about the potential mechanisms of change of mindfulness-based IMIs, which could contribute to optimizing target groups and interventions. Hence, within this secondary analysis of data from a randomized controlled trial (RCT), potential moderators and mediators of the effectiveness of the IMI StudiCare Mindfulness were investigated. Methods: Moderation and mediation analyses were based on secondary data from a RCT that examined the effectiveness of the 7-module IMI StudiCare Mindfulness in a sample of college students (intervention group: n = 217; waitlist control group: n = 127). Assessments were collected before (t0; baseline), 4 weeks after (t1; during intervention), and 8 weeks after (t2; post-intervention) randomization. Longitudinal mediation analyses using structural equation modeling were employed, with depressive symptom severity as the dependent variable. For moderation analyses, bilinear interaction models were calculated with depressive symptom severity and mindfulness at t2 as dependent variables. All data-analyses were performed on an intention-to-treat basis. Results: Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, a*b = 0.153, p < 0.01). Only the number of semesters (interaction: ß = 0.24, p = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction: ß = -0.20, p = 0.047) and baseline self-efficacy (interaction: ß = -0.27, p = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2. Conclusion: Our results suggest a mediating role of mindfulness. Moderation analyses demonstrated that the intervention improved depressive symptom severity and mindfulness independent of most examined baseline characteristics. Future confirmatory trials will need to support these findings. Clinical Trial Registration: The trial was registered a priori at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (TRN: DRKS00014774; registration date: 18 May 2018).

Examining the relationship between cognitive factors and insight in panic disorder before and during treatment.

Individuals with Panic Disorder (PD) often have impaired insight, which can impede their willingness to seek treatment. Cognitive processes, including metacognitive beliefs, cognitive flexibility, and jumping to conclusions (JTC) may influence the degree of insight. By understanding the relationship between insight and these cognitive factors in PD, we can better identify individuals with such vulnerabilities to improve their insight. The aim of this study is to examine the relationships between metacognition, cognitive flexibility, and JTC with clinical and cognitive insight at pretreatment. We investigate the association among those factors' changes and changes in insight over treatment. Eighty-three patients diagnosed with PD received internet-based cognitive behavior therapy. Analyses revealed that metacognition was related to both clinical and cognitive insight, and cognitive flexibility was related to clinical insight at pre-treatment. Greater changes in metacognition were correlated with greater changes in clinical insight. Also, greater changes in cognitive flexibility were related to greater changes in cognitive insight. The current study extends previous studies suggesting potential relationships among insight, metacognition, and cognitive flexibility in PD. Determining the role of cognitive concepts in relation to insight may lead to new avenues for improving insight and can have implications for engagement and treatment-seeking behaviors.

Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial.

BACKGROUND: Excessive crying, sleeping, and feeding problems in early childhood are major stressors that can result in parents feeling socially isolated and having low self-efficacy. Affected children are a risk group for being maltreated and developing emotional and behavioral problems. Thus, the development of an innovative and interactive psychoeducational app for parents of children with crying, sleeping, and feeding problems may provide low-threshold access to scientifically based information and reduce negative outcomes in parents and children. OBJECTIVE: We aimed to investigate whether following the use of a newly developed psychoeducational app, the parents of children with crying, sleeping, or feeding problems experienced less parenting stress; gained more knowledge about crying, sleeping, and feeding problems; and perceived themselves as more self-effective and as better socially supported and whether their children's symptoms decreased more than those of the parents who did not use the app. METHODS: Our clinical sample consisted of 136 parents of children (aged 0-24 months) who contacted a cry baby outpatient clinic in Bavaria (Southern Germany) for an initial consultation. Using a randomized controlled design, families were randomly allocated to either an intervention group (IG; 73/136, 53.7%) or a waitlist control group (WCG; 63/136, 46.3%) during the usual waiting time until consultation. The IG was given a psychoeducational app that included evidence-based information via text and videos, a child behavior diary function, a parent chat forum and experience report, tips on relaxation, an emergency plan, and a regional directory of specialized counseling centers. Outcome variables were assessed using validated questionnaires at baseline test and posttest. Both groups were compared at posttest regarding changes in parenting stress (primary outcome) and secondary outcomes, namely knowledge about crying, sleeping, and feeding problems; perceived self-efficacy; perceived social support; and child symptoms. RESULTS: The mean individual study duration was 23.41 (SD 10.42) days. The IG reported significantly lower levels of parenting stress (mean 83.18, SD 19.94) after app use compared with the WCG (mean 87.46, SD 16.67; P=.03; Cohen d=0.23). Furthermore, parents in the IG reported a higher level of knowledge about crying, sleeping, and feeding (mean 62.91, SD 4.30) than those in the WCG (mean 61.15, SD 4.46; P<.001; Cohen d=0.38). No differences at posttest were found between groups in terms of parental efficacy (P=.34; Cohen d=0.05), perceived social support (P=.66; Cohen d=0.04), and child symptoms (P=.35; Cohen d=0.10). CONCLUSIONS: This study provides initial evidence of the efficacy of a psychoeducational app for parents with child crying, sleeping, and feeding problems. By reducing parental stress and increasing knowledge of children's symptoms, the app has the potential to serve as an effective secondary preventive measure. Additional large-scale studies are needed to investigate long-term benefits. TRIAL REGISTRATION: German Clinical Trials Register DRKS00019001; https://drks.de/search/en/trial/DRKS00019001.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Systematic review of economic evaluations for internet- and mobile-based interventions for mental health problems.

In view of the staggering disease and economic burden of mental disorders, internet and mobile-based interventions (IMIs) targeting mental disorders have often been touted to be cost-effective; however, available evidence is inconclusive and outdated. This review aimed to provide an overview of the cost-effectiveness of IMIs for mental disorders and symptoms. A systematic search was conducted for trial-based economic evaluations published before 10th May 2021. Electronic databases (including MEDLINE, PsycINFO, CENTRAL, PSYNDEX, and NHS Economic Evaluations Database) were searched for randomized controlled trials examining IMIs targeting mental disorders and symptoms and conducting a full health economic evaluation. Methodological quality and risk of bias were assessed. Cost-effectiveness was assumed at or below £30,000 per quality-adjusted life year gained. Of the 4044 studies, 36 economic evaluations were reviewed. Guided IMIs were likely to be cost-effective in depression and anxiety. The quality of most evaluations was good, albeit with some risks of bias. Heterogeneity across studies was high because of factors such as different costing methods, design, comparison groups, and outcomes used. IMIs for anxiety and depression have potential to be cost-effective. However, more research is needed into unguided (preventive) IMIs with active control conditions (e.g., treatment as usual) and longer time horizon across a wider range of disorders.Trial registration: PROSPERO Registration No. CRD42018093808.

Barriers to and Facilitators of Engaging With and Adhering to Guided Internet-Based Interventions for Depression Prevention and Reduction of Pain-Related Disability in Green Professions: Mixed Methods Study.

BACKGROUND: Internet-based interventions (IBIs) are effective for the prevention and treatment of mental disorders and are valuable additions for improving routine care. However, the uptake of and adherence to IBIs are often limited. To increase the actual use of IBIs, it is important to identify factors for engaging with and adhering to IBIs. OBJECTIVE: We qualitatively evaluated barriers and facilitators regarding a portfolio of guided IBIs in green professions (farmers, gardeners, and foresters). METHODS: Interview participants were selected from 2 randomized controlled trials for either the prevention of depression (Prevention of Depression in Agriculturists [PROD-A]) or the reduction of pain interference (Preventive Acceptance and Commitment Therapy for Chronic Pain in Agriculturists [PACT-A]) in green professions. The intervention group in PROD-A (N=180) participated in an IBI program, receiving access to 1 of 6 symptom-tailored IBIs. The intervention group in PACT-A (N=44) received access to an IBI for chronic pain. Overall, 41 semistructured qualitative interviews were conducted and transcribed verbatim. Barriers and facilitators were identified via inductive qualitative content analysis, with 2 independent coders reaching almost perfect intercoder reliability (Cohen κ=0.92). A quantitative follow-up survey (30/41, 73%) was conducted to validate the results. Subgroup analyses were performed based on intervention characteristics. RESULTS: We identified 42 barriers and 26 facilitators, which we assigned to 4 superordinate categories related to the intervention (20 barriers; 17 facilitators), work (4 barriers; 1 facilitator), individual (13 barriers; 8 facilitators), and technical (5 barriers; 0 facilitators) aspects. Key barriers (identified by at least 50% of the interviewees) were time-consuming work life (29/40, 73%) and time-consuming private life (23/40, 58%). Similarly, the most frequently identified facilitators included presence of motivation, curiosity, interest and perseverance (30/40, 75%), flexible time management at work (25/40, 63%), and support from family and friends (20/40, 50%). Although agreement with barriers in the quantitative follow-up survey was rather low (mean 24%, SD 11%), agreement with facilitators was substantially higher (mean 80%, SD 13%). Differences in agreement rates were found particularly between intervention completers and noncompleters. Completers agreed significantly more often that perceived IBI success; being motivated, curious, interested, and perseverant; and having a persisting level of psychological strain have been facilitating. Noncompleters agreed more often with experiencing the e-coach contact as insufficient and technical problems as hindering for intervention completion. CONCLUSIONS: Based on these results, strategies such as customization of modules for more flexible and adaptive use; video chat options with the e-coach; options to facilitate social support by family, friends, or other participants; or using prompts to facilitate training completion can be derived. These approaches could be evaluated in further quantitative research designs in terms of their potential to enhance intervention use in this occupational group. TRIAL REGISTRATION: German Clinical Trials Register DRKS00014000, https://tinyurl.com/3bukfr48; German Clinical Trials Register DRKS0001461, https://tinyurl.com/ebsn4sns.

Lessons Learned from an Attempted Pragmatic Randomized Controlled Trial for Improvement of Chronic Pain-Associated Disability in Green Professions: Long-Term Effectiveness of a Guided Online-Based Acceptance and Commitment Therapy (PACT-A).

Musculoskeletal symptoms are increased in farmers, whereas the prevalence of chronified pain is unknown. Online interventions based on acceptance and commitment therapy (ACT) have shown encouraging results in the general population, representing a promising approach for reducing pain interference in green professions (i.e., farmers, foresters, gardeners). We conducted a pragmatic RCT comparing a guided ACT-based online intervention to enhanced treatment-as-usual in entrepreneurs, contributing spouses, family members and pensioners in green professions with chronic pain (CPG: ≥grade II, ≥6 months). Recruitment was terminated prematurely after 2.5 years at N = 89 (of planned N = 286). Assessments were conducted at 9 weeks (T1), 6 months (T2) and 12 months (T3) post-randomization. The primary outcome was pain interference (T1). The secondary outcomes encompassed pain-, health- and intervention-related variables. No treatment effect for reduction of pain interference was found at T1 (ß = -0.16, 95%CI: -0.64-0.32, p = 0.256). Improvements in cognitive fusion, pain acceptance, anxiety, perceived stress and quality of life were found only at T3. Intervention satisfaction as well as therapeutic and technological alliances were moderate, and uptake and adherence were low. Results are restricted by low statistical power due to recruitment issues, high study attrition and low intervention adherence, standing in contrast to previous studies. Further research is warranted regarding the use of ACT-based online interventions for chronic pain in this occupational group. Trial registration: German Clinical Trial Registration: DRKS00014619. Registered: 16 April 2018.

The Efficacy of a Web-Based Stress Management Intervention for Employees Experiencing Adverse Working Conditions and Occupational Self-efficacy as a Mediator: Randomized Controlled Trial.

BACKGROUND: Work stress is highly prevalent and puts employees at risk for adverse health consequences. Web-based stress management interventions (SMIs) promoting occupational self-efficacy might be a feasible approach to aid employees to alleviate this burden and to enable them to improve an unbalanced situation between efforts and rewards at work. OBJECTIVE: The first aim of this randomized controlled trial was to investigate the efficacy of a web-based SMI for employees perceiving elevated stress levels and an effort-reward imbalance in comparison to a waitlist control (WLC) group. Second, we investigated whether the efficacy of an SMI could be explained by an increase in occupational self-efficacy and whether this personal resource enables employees to change adverse working conditions. METHODS: A total of 262 employees reporting effort-reward imbalance scores over 0.715 and elevated stress levels (10-item Perceived Stress Scale [PSS-10] score ≥22) were randomly assigned to either the intervention group (IG; SMI) or the WLC group. The primary outcome was perceived stress measured using the PSS-10. The secondary outcomes included mental and work-related health measures. Four different mediation analyses were conducted with occupational self-efficacy, efforts, and rewards as mediators. After eligibility screening, data were collected web based at baseline (T1), 7 weeks (T2) and 6 months (T3). RESULTS: Study participation was completed by 80% (105/130, 80.8%) in the IG and 90% (119/132, 90.2%) in the WLC group. Analyses of covariance revealed that stress reduction was significantly higher for the SMI group compared with the WLC group at T2 (d=0.87, 95% CI 0.61-1.12, P<.001) and T3 (d=0.65, 95% CI 0.41-0.90, P<.001). Mediation analyses indicated that occupational self-efficacy mediated the beneficial effect of the SMI on stress directly. Furthermore, the analyses revealed a significant indirect effect of occupational self-efficacy via rewards (b=0.18, t259=4.52, P<.001), but not via efforts (b=0.01, t259=0.27, P>.05) while efforts still had a negative impact on stress (b=0.46, t257=2.32, P<.05). CONCLUSIONS: The SMI was effective in reducing stress and improving occupational self-efficacy in employees despite them experiencing an effort-reward imbalance at work. Results from mediation analyses suggest that fostering personal resources such as occupational self-efficacy contributes to the efficacy of the SMI and enables employees to achieve positive changes regarding the rewarding aspects of the workplace. However, the SMI seemed to neither directly nor indirectly impact efforts, suggesting that person-focused interventions might not be sufficient and need to be complemented by organizational-focused interventions to comprehensively improve mental health in employees facing adverse working conditions. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005990; https://tinyurl.com/23fmzfu3.

Internet- and mobile-based psychological interventions for sexual dysfunctions: a systematic review and meta-analysis.

Sexual dysfunctions are highly prevalent and undertreated. Internet- and mobile-based psychological interventions (IMIs) could be a promising addition to close this treatment gap, given their accessibility, anonymity, and scalability. This systematic review and meta-analysis investigated the efficacy of IMIs for sexual dysfunctions. A comprehensive literature search was conducted in August 2021 on randomized controlled trials investigating the effects of IMIs on sexual functioning and satisfaction compared to a control condition. Twelve RCTs with 14 comparisons were reviewed with six IMIs targeting female and six IMIs targeting male sexual dysfunctions and n = 952 participants were evaluated in the meta-analysis. IMIs were significantly more effective than control conditions (k = 11 waitlist control group, k = 3 online discussion board) at post-treatment for female sexual functioning (g = 0.59, CI: 0.28-0.90, I2 = 0%) and satisfaction (g = 0.90, CI: 0.02-1.79, I2 = 82%), and male sexual functioning (g = 0.18, CI: 0.02-0.34, I2 = 0%). No significant effect was found for male sexual satisfaction (g = 0.69, CI: -0.13-1.51, I2 = 88%) with substantial heterogeneity in studies. Most studies showed high dropout, with ten studies indicating some concern of risk of bias, and two studies showing high risk of bias. The results suggest that IMIs can be an effective treatment for sexual dysfunctions, although additional high-quality research is needed. Given the limited availability of specialized treatment for sexual dysfunctions and individual preferences for discrete treatment options, IMIs seem to be a valuable addition to routine care, empowering individuals to promote their sexual health on a guided self-help basis.