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Objective: Physical activity (PA) interventions are part of many interdisciplinary programs for the management of children and adolescents with or without physical or psychological conditions or disabilities. Aiming to summarize the available evidence, we conducted an umbrella review of meta-analyses of PA interventions that included psychosocial outcomes in populations of children and adolescents., Method: Literature searches were conducted in PubMed, Cochrane Central, Web of Science, Medline, SPORTDiscus, and PsychInfo from January 1, 2010, to May 6, 2022. Meta-analyses of randomized and quasi-randomized studies investigating the efficacy of PA interventions for psychosocial outcomes in children and adolescents were included. Summary effects were recalculated using common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small study effects, and whether the results of the observed positive studies were greater than expected due to chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Quality was assessed using the AMSTAR 2 tool. This study is registered with the Open Science Framework, https://osf.io/ap8qu., Results: A total of 112 studies from 18 meta-analyses generating 12 new meta-analyses comprising 21,232 children and adolescents in population groups including attention-deficit/hyperactivity disorder, cancer, cerebral palsy, chronic respiratory diseases, depression, neuromotor impairment, and obesity and in general populations were included. PA interventions were efficacious in reducing psychological symptoms in all meta-analyses across the different population groups using random-effects models. However, umbrella review criteria suggested a weak strength of association for this outcome, and GRADE credibility of evidence ranged from moderate to very low. For psychological well-being, 3 out of 5 meta-analyses identified significant effects, but the strength of these associations was weak, and GRADE credibility of evidence ranged from moderate to very low. Similarly, for social outcomes, meta-analyses reported a significant summary effect, but the strength of association was weak, and GRADE credibility of evidence ranged from moderate to very low. For self-esteem, one meta-analysis in children with obesity failed to show any effect., Conclusion: Even though existing meta-analyses suggested a beneficial effect of PA interventions on psychosocial outcomes across different population groups, the strength of associations was weak, and the credibility of evidence was variable depending on the target population, outcome, and condition or disability. Randomized studies of PA interventions in children and adolescents with and without different physical and psychological conditions or disabilities should always include psychosocial outcomes as an important dimension of social and mental health., Study Preregistration Information: Prenatal Maternal Infection and Adverse Neurodevelopment: A Structural Equation Modelling Approach to Downstream Environmental Hits; https://osf.io/; ap8qu., (Copyright © 2023. Published by Elsevier Inc.)

Since 1977, the WHO Model Lists of Essential Medicines (EML) have been a benchmark to guide the procurement of medicines at the national level, especially in low-income and middle-income countries. Aiming to include the most effective, safe, and cost-effective medicines for priority conditions, WHO updates the EML for adults and the EML for children every 2 years. Over the past 45 years, updates to the EML mental health section have been infrequent, in most cases with additions of individual medicines. A comprehensive revision of the entire section has never been attempted. With the aim of increasing the use of the WHO EML to expand the selection of the most effective and safe medicines for mental disorders, a series of evidence-based applications were submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines in 2022, recommending a substantial revision of the entire mental health section. In this Health Policy, we summarise the recommended update and the evidence justifying it. We also discuss challenges in the update process, suggesting possible solutions. The requested comprehensive revision of the WHO EML mental health section aligns the list with the latest evidence. The revision offers an opportunity for countries to promote access to the most effective, safe, and cost-effective medicines for mental disorders, contributing to universal health coverage and global mental health equity., Competing Interests: Declaration of interests DP, GO, BT, CG, and CB developed nine of the 13 applications submitted to the 24th WHO Expert Committee on the Selection and Use of Essential Medicines. WHO commissioned the nine applications, and the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation of the University of Verona received funding from WHO for their development. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Aims: As refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe., Methods: Refugees and asylum seekers with psychological distress (General Health Questionnaire-12 ⩾ 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes., Results: Of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p -value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p -value = 0.230). SH + was associated with improvements at 12 months in psychological distress ( p -value = 0.004), depressive symptoms ( p -value = 0.011) and wellbeing ( p -value = 0.001)., Conclusions: The present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence.

Background: Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses., Objective: Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors., Methods: The STAR Network 'Depot Study' was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively., Results: The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4-44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3-43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4-84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6-40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6-27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742-0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003-4.634; p = 0.049)., Conclusions: Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation.

Introduction: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress., Objective: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe., Methods: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes., Results: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52-1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29-0.87)., Conclusions: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified., (© 2021 The Author(s) Published by S. Karger AG, Basel.)

Background: The novel coronavirus pandemic calls for a rapid adaptation of conventional medical practices to meet the evolving needs of such vulnerable patients. People with coronavirus disease (COVID-19) may frequently require treatment with psychotropic medications, but are at the same time at higher risk for safety issues because of the complex underlying medical condition and the potential interaction with medical treatments., Methods: In order to produce evidence-based practical recommendations on the optimal management of psychotropic medications in people with COVID-19, an international, multi-disciplinary working group was established. The methodology of the WHO Rapid Advice Guidelines in the context of a public health emergency and the principles of the AGREE statement were followed. Available evidence informing on the risk of respiratory, cardiovascular, infective, hemostatic, and consciousness alterations related to the use of psychotropic medications, and drug-drug interactions between psychotropic and medical treatments used in people with COVID-19, was reviewed and discussed by the working group., Results: All classes of psychotropic medications showed potentially relevant safety risks for people with COVID-19. A set of practical recommendations was drawn in order to inform frontline clinicians on the assessment of the anticipated risk of psychotropic-related unfavorable events, and the possible actions to take in order to effectively manage this risk, such as when it is appropriate to avoid, withdraw, switch, or adjust the dose of the medication., Conclusions: The present evidence-based recommendations will improve the quality of psychiatric care in people with COVID-19, allowing an appropriate management of the medical condition without worsening the psychiatric condition and vice versa.

Background: Mental health conditions are leading causes of disability worldwide. Psychosocial interventions for these conditions might have a key role in their treatment, although applicability of findings to poor-resource settings might be a challenge. We aimed to evaluate the strength and credibility of evidence generated in low-income and middle-income countries (LMICs) on the efficacy of psychosocial interventions for various mental health outcomes., Methods: We did an umbrella review of meta-analyses of randomised studies done in LMICs. Literature searches were done in Medline, Embase, PsychINFO, CINAHL, Cochrane Library, and Epistemonikos from Jan 1, 2010, until May 31, 2019. Systematic reviews of randomised studies investigating the efficacy of psychosocial interventions for mental health conditions in LMICs were included. Systematic reviews of promotion, prevention, and protection interventions were excluded, because the focus was on treatment interventions only. Information on first author, year of publication, outcomes, number of included studies, and reported summary meta-analytic estimates was extracted from included meta-analyses. Summary effects were recalculated using a common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small-study effects, and whether the results of the observed positive studies were more than expected by chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence using the GRADE approach. This study is registered with PROSPERO, number CRD42019135711., Findings: 123 primary studies from ten systematic reviews were included. The evidence on the efficacy of psychosocial interventions in adults with depression in humanitarian settings (standardised mean difference 0·87, 95% CI 0·67-1·07; highly suggestive association, GRADE: moderate) and in adults with common mental disorders (0·49, 0·36-0·62; highly suggestive association, GRADE: moderate) was supported by the most robust evidence. Highly suggestive strength of association was found for psychosocial interventions in adults with schizophrenia for functional outcomes, in adults with depression, and in adults with post-traumatic stress disorder in humanitarian settings. In children in humanitarian settings, and in children with disruptive behaviour, psychosocial interventions were supported by suggestive evidence of efficacy., Interpretation: A relatively large amount of evidence suggests the benefit of psychosocial interventions on various mental health outcomes in LMICs. However, strength of associations and credibility of evidence were quite variable, depending on the target mental health condition, type of population and setting, and outcome of interest. This varied evidence should be considered in the development of clinical, policy, and implementation programmes in LMICs and should prompt further studies to improve the strength and credibility of the evidence base., Funding: University of Verona., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Introduction: This article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey., Methods and Analysis: Two prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness., Ethics and Dissemination: The two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings., Trials Registration Numbers: NCT03571347, NCT03587896., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

In recent years there has been a progressive rise in the number of asylum seekers and refugees displaced from their country of origin, with significant social, economic, humanitarian and public health implications. The aim of this study is to describe the frequency and correlates of psychological distress and psychiatric disorders in asylum seekers and refugees resettled in an Italian catchment area. In the catchment area of Verona, all male asylum seekers and refugees aged 18 or above included in the Italian protection system for asylum seekers and refugees during a period of 1 year were screened for psychological distress and psychiatric disorders using validated questionnaires. During the study period, 109 asylum seekers or refugees were recruited. The frequency of traumatic events experienced was very high. More than one-third of the participants (36%) showed clinically relevant psychological distress, and one-fourth (25%), met the criteria for a psychiatric diagnosis, mainly PTSD and depressive disorders. In multivariate analyses, time after departure, length of stay in the host country and number of traumatic events were independent factors associated with psychological distress and psychiatric disorders. In an unselected sample of male asylum seekers and refugees, after around 1 year of resettlement in an Italian catchment area, the frequency of psychological distress and psychiatric disorders was substantial and clinically relevant. Health care systems should include a mental health component to recognise and effectively treat mental health conditions.

Research evidence guiding the identification of pragmatic and effective actions aimed at improving the selection, availability, affordability and rational prescribing of medicines for mental disorders is sparse and inconsistent. In order to boost the development of new research, in this commentary we suggest to organise and classify all the activities in this area under a common theoretical framework and nomenclature, adopting the term 'public health psychopharmacology'. Public health psychopharmacology is proposed as a research discipline, based on contributions from the fields of regulatory science, health services research and implementation science. Implementing the term public health psychopharmacology may offer advantages, as the scientific community would be more focused on common goals and objectives, with, likely, an increasing body of research evidence of practical use.

Recently, many authors highlighted the potential advantages of a broader prescription of long-acting injectable antipsychotics (LAIs) based on various assumptions, including favorable pharmacokinetic features. In this systematic review, data from randomized controlled trials comparing LAIs versus the oral formulation of the same antipsychotic were meta-analyzed in order to ascertain whether the route of administration may be associated with a different efficacy and tolerability profile. Of 21 included studies, 18 contributed to the meta-analysis, providing data for risperidone, olanzapine, aripiprazole, zuclopenthixol, fluphenazine and haloperidol. For all drugs, the number of dropouts for any reason (primary outcome) did not differ between the two formulations, except for a small effect in favor of LAI aripiprazole (2 comparisons; 986 patients; relative risk (RR) 0.78; 95% confidence interval (CI) 0.64 to 0.95). Similarly, no differences emerged in terms of dropouts for adverse events, extrapyramidal symptoms, prolactin increase (except for a small advantage for LAI risperidone), weight gain, non-response rate, relapse rate, and dropouts for inefficacy (except for a small advantage for oral olanzapine). Data on aripiprazole proved to be of high quality according to the GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation), therefore we are confident that the effect estimate is close to the true effect. Data on risperidone were of moderate quality, while data on olanzapine, fluphenazine, zuclopenthixol and haloperidol were of low quality. In conclusion, there is no robust evidence to support doctors in choosing LAI instead of oral formulations in order to obtain better tolerability and efficacy., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Objective: Corrected QT (QTc) interval prolongation is often associated with use of first-generation antipsychotics (FGAs). However, other factors require appropriate consideration, including age and gender, the role of other known medications associated with QTc prolongation, and severe comorbid conditions, such as co-occurring alcohol abuse/dependence. We aimed to study potential mediating roles of different, related, candidate variables on QTc., Methods: We capitalized on data from a large (N = 2366), cross-sectional, national survey, the STAR Network QTc study, using a representative sample of people taking FGAs, and recruited from mental health services across Italy., Results: About one-third of the sample was treated with FGAs, and almost one-tenth of the subjects took a different, additional, drug known to cause QTc prolongation. Our findings confirmed that there is an impact from FGAs, age, gender, alcohol misuse, and concurrent risky drugs on QTc. However, comorbid alcohol abuse/dependence and concurrent risky drugs did not mediate the effect of FGAs on QTc., Conclusions: Our findings showed that FGAs, concurrent risky drugs, and alcohol use disorders prolonged QTc. FGAs had a direct effect on QTc, confirming the need for clinicians to monitor a risk that could lead to sudden unexplained death. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)