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BACKGROUND: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics. METHODS: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree. RESULTS: IPD were obtained from four of seven eligible studies (N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment (d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up (d = -0.84 [95% CI -1.11 to -0.57]). In the subsample (n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators. CONCLUSIONS: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.
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Insomnia is a primary symptom of shift work disorder, yet it remains undertreated. This randomised-controlled pilot trial examined the efficacy of a digital, guided cognitive behavioural therapy for insomnia adapted to shift work (SleepCare) in nurses with shift work disorder. The hypothesis was that SleepCare reduces insomnia severity compared with a waitlist control condition. A total of 46 unmedicated nurses suffering from shift work disorder with insomnia (age: 39.7 ± 12.1 years; 80.4% female) were randomised to the SleepCare group or the waitlist control group. The primary outcome measure was the Insomnia Severity Index. Other questionnaires on sleep, mental health and occupational functioning, sleep diary data and actigraphy data were analysed as secondary outcomes. Assessments were conducted before (T0), after the intervention/waitlist period (T1), and 6 months after treatment completion (T2). The SleepCare group showed a significant reduction in insomnia severity from T0 to T1 compared with the control condition (ß = -4.73, SE = 1.12, p < 0.001). Significant improvements were observed in sleepiness, dysfunctional beliefs about sleep, pre-sleep arousal, sleep effort, self-reported sleep efficiency and sleep onset latency. No significant effect was found in actigraphy data. Depressive and anxiety symptoms, cognitive irritation and work ability improved significantly. Overall, satisfaction and engagement with the intervention was high. SleepCare improved insomnia severity, sleep, mental health and occupational functioning. This is the first randomised-controlled trial investigating the efficacy of digital cognitive behavioural therapy for insomnia in a population suffering from shift work disorder with insomnia. Future research should further explore these effects with larger sample sizes and active control conditions.
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BACKGROUND: Evidence shows that online interventions could prevent depression. However, to improve the effectiveness of preventive online interventions in individuals with subthreshold depression, it is worthwhile to study factors influencing intervention outcomes. Outcome expectancy has been shown to predict treatment outcomes in psychotherapy for depression. However, little is known about whether this also applies to depression prevention. The aim of this study was to investigate the role of participants' outcome expectancy in an online depression prevention intervention. METHODS: A secondary data analysis was conducted using data from two randomised-controlled trials (N = 304). Multilevel modelling was used to explore the effect of outcome expectancy on depressive symptoms and close-to-symptom-free status postintervention (6-7 weeks) and at follow-up (3-6 months). In a subsample (n = 102), Cox regression was applied to assess the effect on depression onset within 12 months. Explorative analyses included baseline characteristics as possible moderators. Outcome expectancy did not predict posttreatment outcomes or the onset of depression. RESULTS: Small effects were observed at follow-up for depressive symptoms (ß = -.39, 95% confidence interval [CI]: [-0.75, -0.03], p = .032, padjusted = .130) and close-to-symptom-free status (relative risk = 1.06, 95% CI: [1.01, 1.11], p = .013, padjusted = 0.064), but statistical significance was not maintained when controlling for multiple testing. Moderator analyses indicated that expectancy could be more influential for females and individuals with higher initial symptom severity. CONCLUSION: More thoroughly designed, predictive studies targeting outcome expectancy are necessary to assess the full impact of the construct for effective depression prevention. PATIENT OR PUBLIC CONTRIBUTION: This secondary analysis did not involve patients, service users, care-givers, people with lived experience or members of the public. However, the findings incorporate the expectations of participants using the preventive online intervention, and these exploratory findings may inform the future involvement of participants in the design of indicated depression prevention interventions for adults. CLINICAL TRIAL REGISTRATION: Original studies: DRKS00004709, DRKS00005973; secondary analysis: osf.io/9xj6a.
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Depressão , Humanos , Feminino , Masculino , Depressão/prevenção & controle , Adulto , Pessoa de Meia-Idade , Internet , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Intervenção Baseada em InternetRESUMO
BACKGROUND: Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in micro- and small-sized enterprises (MSE). Main barriers include a lack of knowledge and limited resources, which could potentially be overcome with simplified web-based alternatives for occupational stress prevention. However, there is a lack of implementation research about web-based prevention in realistic settings of MSE. OBJECTIVE: The aim of this study is to evaluate the implementation process and success of an integrated web-based platform for occupational stress prevention ("System P") and to identify potential barriers for its uptake and use in MSE in Germany. METHODS: This study with a mixed-methods approach investigates eight process-related outcomes in a quantitative part I (adoption, reach, penetration, fidelity/dose, costs, acceptability) and a qualitative part II (acceptability, appropriateness and feasibility). Part I has a pre-post design with two measurements (6 months apart) with 98 individual participants and part II consists of 12 semi-structured interviews with managers and intercorporate stakeholders. RESULTS: Part I revealed shortcomings in the implementation process. Adoption/Reach: Despite extensive marketing efforts, less than 1% of the contacted MSE responded to the offer of System P. A total of 40 MSE registered, 24 of which, characterized by good psychosocial safety climate, adopted System P. Penetration: Within these 24 MSE, 15% of the employees used the system. Fidelity/Dose: 11 MSE started a psychosocial risk-assessment (PRA), and no MSE finished it. The stress-management training (SMT) was started by 25 users and completed by 8. COSTS: The use of System P was free of charge, but the time required to engage with was an indirect cost. Part II added insights on the perception of the web-based intervention: Acceptance of System P by users and stakeholders was good and it was assessed as appropriate for MSE. Results for feasibility were mixed. CONCLUSIONS: Although System P was generally perceived as useful and appropriate, only a small number of contacted MSE implemented it as intended. Prior experience and sensitivity for occupational (stress) prevention were mentioned as key facilitators, while (perceived) indirect costs were a key barrier. Enabling MSE to independently manage stress prevention online did not result in successful implementation. Increasing external support could be a solution. ⺠FULL PROJECT NAME: "PragmatiKK - Pragmatische Lösungen für die Implementation von Maßnahmen zur Stressprävention in Kleinst- und Kleinbetrieben" (= Pragmatic solutions for the implementation of stress prevention interventions in micro and small-sized enterprises). TRIAL REGISTRATION: German Register of Clinical Studies (DRKS) DRKS00026154, date of registration 2021-09-16.
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Estresse Ocupacional , Humanos , Alemanha , Estresse Ocupacional/prevenção & controle , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Empresa de Pequeno Porte , Internet , Avaliação de Programas e Projetos de Saúde , Intervenção Baseada em Internet , Pesquisa QualitativaRESUMO
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.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Humanos , Afeto , Depressão/terapia , Saúde DigitalRESUMO
Recovering from work is essential for maintaining occupational well-being, health, motivation, and performance, but recovery is often difficult to achieve. In this study, we evaluated and compared the effectiveness of two (parallel) interventions aimed at promoting recovery: one based on mindfulness and one involving applying cognitive-behavioral strategies. Both interventions were embedded in a measurement burst design, which allowed us to examine the mechanisms underlying change or intervention success. To explore mechanisms of change, we used the stressor-detachment model as a theoretical framework. We operationalized the interventions' effects in three ways: as changes from pretest to posttest, as changes in daily states, and as changes in daily associations. To this end, we used intensive longitudinal data to examine the roles that daily negative activation plays in detachment and strain. In a randomized controlled trial (N = 393), we administered three assessments of traits: pretest, posttest (8 weeks later), and follow-up (3 months after the posttest). We also administered 2 work weeks of experience sampling questionnaires (preintervention and postintervention). Latent change models and Bayes factor equivalence tests revealed that both interventions substantially-and to a similar extent-increased detachment. Bayesian multilevel path models showed improvements in all state variables, including improvements in negative activation, and provided some evidence that mindfulness-based and cognitive-behavioral approaches might tackle different processes at the daily level. We discuss theoretical implications for the literature on recovery from work and specifically for the stressor-detachment model. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Terapia Cognitivo-Comportamental , Atenção Plena , Humanos , Feminino , Masculino , Adulto , Terapia Cognitivo-Comportamental/métodos , Pessoa de Meia-Idade , Inquéritos e Questionários , Teorema de Bayes , Estresse Ocupacional/psicologia , Estudos LongitudinaisRESUMO
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.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Humanos , Teorema de Bayes , Distúrbios do Início e da Manutenção do Sono/terapia , Sono , Coleta de DadosRESUMO
BACKGROUND: Therapist-guided exposure and response prevention (ERP) for the treatment of obsessive-compulsive disorder (OCD) is frequently conducted within clinical settings but rarely at places where patients are usually confronted with OCD symptom-provoking situations in daily life (eg, at home). OBJECTIVE: This study aimed to investigate patients' views on 1 ERP session at home via videoconference and its impact on treatment outcome. METHODS: A total of 64 inpatients with OCD received 1 session of therapist-guided videoconference-based ERP at home in adjunction to a multimodal inpatient treatment between 2015 and 2020. RESULTS: Compared with 64 age- and sex-matched controls who received a multimodal inpatient treatment without 1 session of videoconference-based ERP at home, patients who received 1 session of videoconference-based ERP in adjunction to a multimodal inpatient treatment showed stronger reductions in OCD symptom severity from admission to discharge. Before the videoconference-based ERP session, patients reported high rationale credibility and treatment expectancy. After the videoconference-based ERP session, patients reported medium-to-high positive mood as well as depth and smoothness of the session, and they perceived the working alliance as high. CONCLUSIONS: Results highlight the importance of administering therapist-guided ERP sessions in patients' natural environment to enhance treatment response in OCD. Videoconference-based ERP as add-on to treatment as usual is, therefore, a promising approach to facilitate the application of ERP in patients' natural environment and foster the generalization of ERP conducted in clinical settings.
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Assistência Odontológica , Pacientes Internados , Humanos , Hospitalização , Alta do Paciente , Comunicação por VideoconferênciaRESUMO
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).
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Depressão , Humanos , Depressão/diagnóstico , Depressão/terapia , Prognóstico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.