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Background Prevalence rates of anxiety and depression in adolescence are rising markedly in early adolescence. It is important to quantify the non-fatal disease burden of anxiety and depression, such that early interventions can be well targeted, and resources can be allocated in a just and optimal way. This study aimed to estimate the non-fatal disease burden of anxiety and depression with and without suicidal ideation in girls and boys aged 13, 14, and 15 years. Methods Participants were 53,894 secondary school pupils who completed health questionnaires between September 2018 and July 2019. A design-based approach was used for complex survey data with post-stratification weights and taking clustering at school-level into account. At individual level, disability weights (DWs) were calculated for each disorder. At population level, DWs were multiplied by the point-prevalence per one thousand population of the respective disorders to compute years lived with disability (YLD). DWs and YLD of anxiety and depression were calculated with and without adjustment for comorbid eating disorders, substance use disorders and somatic illnesses. Results The unadjusted DW of depression with suicidal ideation (0.30) was greater than without suicidal ideation (0.26), and both were greater than the DW of anxiety (0.24). A similar ranking was obtained after adjusting for comorbidities. At population level, where the prevalence of the disorders come into play, the YLD disease burden was greatest for anxiety, followed by depression with suicidal ideation and depression without suicidal ideation with 17.40, 9.85, and 5.28 YLD per one thousand population, unadjusted for comorbidities. This pattern was the same after adjustment, but then the total YLD of depression with and without suicidal ideation was similar to the YLD of anxiety (12.47 and 12.46, respectively). Girls showed a significantly greater YLD burden of anxiety and depression than boys, but no differences were found between different age groups. Conclusions From an individual clinical perspective, depression, especially when accompanied by suicidal ideation, was identified as a major health concern, especially in girls. From a public health perspective, both anxiety and depression, especially when accompanied by suicidal ideation, were identified as major drivers of disease burden, again most notably in girls.

Background Randomized trials can show whether a treatment effect is statistically significant and can describe the size of the effect. There are, however, no validated methods available for establishing the clinical relevance of these outcomes. Recently, it was proposed that a standardized mean difference (SMD) of 0.50 be used as cutoff for clinical relevance in the treatment of depression. Methods We explore what the effect size means and why the size of an effect has little bearing on its clinical relevance. We will also examine how the “minimally important difference,” as seen from the patient perspective, may be helpful in deciding where the cutoff for clinical relevance should be placed for a given condition. Results Effect sizes in itself cannot give an indication of the clinical relevance of an intervention because the outcome itself determines the clinical relevance and not only the size of the effects. The “minimal important difference” (MID) could be used as a starting point for pinpointing the cutoff for clinical relevance. A first, rough attempt to implement this approach for depression resulted in a tentative clinical relevance cutoff of SMD = 0.24. Using this cutoff, psychotherapy, pharmacotherapy, and combined treatment have effect sizes above this cutoff. Discussion Statistical outcomes cannot be equated with clinical relevance. The “MID” may be used for pinpointing the cutoff for clinical relevance, but more work in this area is needed.

Background Antipsychotic medication is effective for symptomatic treatment in schizophrenia-spectrum disorders. After symptom remission, continuation of antipsychotic treatment is associated with lower relapse rates and lower symptom severity compared to dose reduction/discontinuation. Therefore, most guidelines recommend continuation of treatment with antipsychotic medication for at least 1 year. Recently, however, these guidelines have been questioned as one study has shown that more patients achieved long-term functional remission in an early discontinuation condition—a finding that was not replicated in another recently published long-term study. Methods/design The HAMLETT (Handling Antipsychotic Medication Long-term Evaluation of Targeted Treatment) study is a multicenter pragmatic single-blind randomized controlled trial in two parallel conditions (1:1) investigating the effects of continuation versus dose-reduction/discontinuation of antipsychotic medication after remission of a first episode of psychosis (FEP) on personal and social functioning, psychotic symptom severity, and health-related quality of life. In total 512 participants will be included, aged between 16 and 60 years, in symptomatic remission from a FEP for 3–6 months, and for whom psychosis was not associated with severe or life-threatening self-harm or violence. Recruitment will take place at 24 Dutch sites. Patients are randomized (1:1) to: continuation of antipsychotic medication until at least 1 year after remission (original dose allowing a maximum reduction of 25%, or another antipsychotic drug in similar dose range); or gradual dose reduction till eventual discontinuation of antipsychotics according to a tapering schedule. If signs of relapse occur in this arm, medication dose can be increased again. Measurements are conducted at baseline, at 3, and 6 months post-baseline, and yearly during a follow-up period of 4 years. Discussion The HAMLETT study will offer evidence to guide patients and clinicians regarding questions concerning optimal treatment duration and when to taper off medication after remission of a FEP. Moreover, it may provide patient characteristics associated with safe dose reduction with a minimal risk of relapse. Trial status Protocol version 1.3, October 2018. The study is active and currently recruiting patients (since September 2017), with the first 200 participants by the end of 2019. We anticipate completing recruitment in 2022 and final assessments (including follow-up 3.5 years after phase one) in 2026. Trial registration European Clinical Trials Database, EudraCT number 2017-002406-12 . Registered 7 June 2017.

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.

Abstract Study Objectives: Lost productivity caused by insomnia is a common and costly problem for employers. Although evidence for the efficacy of Internet-based cognitive behavioral therapy for insomnia (iCBT-I) already exists, little is known about its economic effects. This study aims to evaluate the cost-effectiveness and cost-benefit of providing iCBT-I to symptomatic employees from the employer's perspective. Methods: School teachers (N = 128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a waitlist-control-group, both with access to treatment as usual. Economic data were collected at baseline and 6-mo follow-up. We conducted (1) a cost-effectiveness analysis with treatment response (Reliable Change [decline of 5.01 points] and Insomnia Severity Index < 8 at 6-month follow-up) as the outcome and (2) a cost-benefit analysis. Because both analyses were performed from the employer's perspective, we focused specifically on absenteeism and presenteeism costs. Statistical uncertainty was estimated using bootstrapping. Results: Assuming intervention costs of €200 ($245), cost-effectiveness analyses showed that at a willingness-to-pay of €0 for each positive treatment response, there is an 87% probability that the intervention is more cost effective than treatment as usual alone. Cost-benefit analyses led to a net benefit of €418 (95% confidence interval: −593.03 to 1,488.70) ($512) per participant and a return on investment of 208% (95% confidence interval: −296.52 to 744.35). The reduction in costs was mainly driven by the effects of the intervention on presenteeism and to a lesser degree by reduced absenteeism. Conclusions: Focusing on sleep improvement using iCBT-I may be a cost-effective strategy in occupational health care. Clinical Trials Registration: Title: Online Recovery Training for Better Sleep in Teachers with High Psychological Strain. German Clinical Trial Register (DRKS), URL: https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004700. Identifier: DRKS00004700. Commentary: A commentary on this article appears in this issue on page 1767.

A previous randomized controlled trial in older adults with anxiety symptoms found no differences between a brief blended Acceptance and Commitment Therapy (ACT) intervention and brief face-to-face Cognitive Behavior Therapy (CBT) regarding anxiety symptom severity at posttreatment and 12-month follow-up. A health-economic evaluation comparing these interventions has not yet been conducted. This study examined the one-year cost-effectiveness and cost-utility of blended ACT compared to face-to-face CBT for older adults with anxiety symptoms. The economic evaluation was embedded in a randomized controlled trial comparing blended ACT to CBT in 314 older adults with mild to moderately severe anxiety symptoms. Data were collected at baseline and 3, 6 and 12 months post baseline. For the cost-effectiveness analysis, treatment response was defined as a reliable improvement in anxiety symptom severity (measured with the Generalized Anxiety Disorder-7) between baseline and 12-month follow-up. To assess cost-utility, quality-adjusted life years (QALYs) were computed using EuroQol-5 Dimensions-5 Levels-5 utility scores. Analyses took the societal perspective, including both healthcare costs and productivity costs. Incremental cost-effectiveness ratios were calculated using 2500 bootstraps of seemingly unrelated regression equations of costs and effects. Sensitivity analyses were performed to assess the robustness of the findings. Differences between the blended ACT group and CBT group in treatment response and QALYs were statistically insignificant and clinically irrelevant. The ACT intervention was associated with an average per-participant cost reduction of €466 ($593) compared to CBT, which resulted from lower productivity costs in the blended ACT group. From a healthcare perspective, the ACT intervention was associated with higher costs (by €71 ($90)) than CBT. The results do not indicate that from a health-economic perspective blended ACT should be preferred over CBT in the treatment of older adults with anxiety symptoms. The findings support a model of shared decision making, where clinicians and patients collaboratively decide on the preferred intervention, based on ethical-medical, practical and personal considerations. Netherlands Trial Register: TRIAL NL6131 (NTR6270); https://www.trialregister.nl/trial/6131.

Objectives. We assessed whether an intervention based on acceptance and commitment therapy (ACT) and mindfulness was successful in promoting positive mental health by enhancing psychological flexibility. Methods. Participants were 93 adults with mild to moderate psychological distress. They were randomly assigned to the group intervention (n = 49) or to a waiting-list control group (n = 44). Participants completed measures before and after the intervention as well as 3 months later at follow-up to assess mental health in terms of emotional, psychological, and social well-being (Mental Health Continuum–Short Form) as well as psychological flexibility (i.e., acceptance of present experiences and value-based behavior, Acceptance and Action Questionnaire-II). Results. Regression analyses showed that compared with the participants on the waiting list, participants in the ACT and mindfulness intervention had greater emotional and psychological well-being after the intervention and also greater psychological flexibility at follow-up. Mediational analyses showed that the enhancement of psychological flexibility during the intervention mediated the effects of the intervention on positive mental health. Conclusions. The intervention is effective in improving positive mental health by stimulating skills of acceptance and value-based action.

PurposeThe Stress-Prevention@Work implementation strategy has been demonstrated to be successful in reducing stress in employees. Now, we assess the economic return-on-investment to see if it would make for a favourable business case for employers.MethodsData were collected from 303 health-care workers assigned to either a waitlisted control condition (142 employees in 15 teams) or to Stress-Prevention@Work (161 employees in 15 teams). Main outcome was productivity losses measured using the Trimbos and iMTA Cost questionnaire in Psychiatry. Measurements were taken at baseline, 6, and 12 months post-baseline.ResultsThe per-employee costs of the strategy were €50. Net monetary benefits were the benefits (i.e., improved productivity) minus the costs (i.e., intervention costs) and were the main outcome of this investment appraisal. Per-employee net benefits amounted to €2981 on average, which was an almost 60-fold payout of the initial investment of €50. There was a 96.7% likelihood for the modest investment of €50 to be offset by cost savings within 1 year. Moreover, a net benefit of at least €1000 still has a likelihood of 88.2%.ConclusionsIn general, there was a high likelihood that Stress-Prevention@Work offers an appealing business case from the perspective of employers, but the employer should factor in the additional per-employee costs of the stress-reducing interventions. Still, if these additional costs were as high as €2981, then costs and benefits would break even.This study was registered in the Netherlands National Trial Register, trial code: NTR5527.

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. 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. 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. 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%. Digital preventive stress management for employees appears to be cost-effective societally and provides a favorable return on investment for employers. German Clinical Trials Register DRKS00005699; https://drks.de/search/en/trial/DRKS00005699.

Stigma and limited mental health literacy impede adolescents getting the help they need for depressive symptoms. A serious game coupled with a classroom session led by lived experience workers (LEWs) might help to overcome these barriers. The school-based Strong Teens and Resilient Minds (STORM) preventive program employed this strategy and offered a serious game, Moving Stories. The current study was carried out to assess inhibiting and promoting factors for scaling up Moving Stories once its effectiveness has been ascertained. Moving Stories was offered in three steps: (1) introductory classroom session, (2) students playing the game for five days, (3) debriefing classroom session led by lived experience worker. Data was collected on the number of participating students, costs of offering Moving Stories, and was further based on the notes of the debriefing sessions to check if mental health first aid (MHFA) strategies were addressed. Moving Stories was offered in seven high-schools. Coverage was moderate with 982 participating students out of 1880 (52%). Most participating students (83%) played the Moving Stories app three out of the five days. Qualitative data showed that the MHFAs were discussed in all debriefing sessions. Students showed great interest in lived experience workers' stories and shared their own experiences with depression. Bringing Moving Stories to scale in the high-school setting appears feasible, but will remain logistically somewhat challenging. Future implementation and scale-up of Moving Stories could benefit from improved selection and training of LEWs that played such an important role in grabbing the full attention of students and were able to launch frank discussions about depressive disorder and stigma in classrooms. The study is registered in the Dutch Trial Register: Trial NL6444 (NTR6622: https://www.trialregister.nl/trial/6444).