Views and experiences of migrants and stakeholders involved in social and health care for migrants in Italy during the COVID-19 pandemic: a qualitative study.

BACKGROUND: The COVID-19 pandemic has had major and potentially long-lasting effects on mental health and wellbeing across populations worldwide. However, these impacts were not felt equally, leading to an exacerbation of health inequalities, especially affecting vulnerable populations such as migrants, refugees and asylum seekers. Aiming to inform the adaptation and implementation of psychological intervention programmes, the present study investigated priority mental health needs in this population group. METHODS: Participants were adult asylum seekers, refugees and migrants (ARMs) and stakeholders with experience in the field of migration living in Verona, Italy, and fluent in Italian and English. A two-stage process was carried out to examine their needs using qualitative methods including free listing interviews and focus group discussions, according to Module One of the DIME (Design, Implementation, Monitoring, and Evaluation) manual. Data were analyzed using an inductive thematic analyses approach. RESULTS: A total of 19 participants (12 stakeholders, 7 ARMs) completed the free listing interviews and 20 participants (12 stakeholders and 8 ARMs) attended focus group discussions. Salient problems and functions that emerged during free listing interviews were discussed during the focus group discussions. During the COVID-19 pandemic, ARMs struggled with many everyday living difficulties in their resettlement country due to social and economic issues, revealing a strong influence of contextual factors in determining mental health. Both ARMs and stakeholders highlighted a mismatch between needs, expectations and interventions as factors that may hamper proper implementation of health and social programmes. CONCLUSIONS: The present findings could help in the adaptation and implementation of psychological interventions targeting the needs of asylum seekers, refugees and migrants aiming to find a match between needs, expectations, and the corresponding interventions. TRIAL REGISTRATION: Registration number 2021-UNVRCLE-0106707, February 11 2021.

Effectiveness of a stepped-care programme of WHO psychological interventions in migrant populations resettled in Italy: Study protocol for the RESPOND randomized controlled trial.

Introduction: Migrant populations, including workers, undocumented migrants, asylum seekers, refugees, internationally displaced persons, and other populations on the move, are exposed to a variety of stressors and potentially traumatic events before, during, and after the migration process. In recent years, the COVID-19 pandemic has represented an additional stressor, especially for migrants on the move. As a consequence, migration may increase vulnerability of individuals toward a worsening of subjective wellbeing, quality of life, and mental health, which, in turn, may increase the risk of developing mental health conditions. Against this background, we designed a stepped-care programme consisting of two scalable psychological interventions developed by the World Health Organization and locally adapted for migrant populations. The effectiveness and cost-effectiveness of this stepped-care programme will be assessed in terms of mental health outcomes, resilience, wellbeing, and costs to healthcare systems. Methods and analysis: We present the study protocol for a pragmatic randomized study with a parallel-group design that will enroll participants with a migrant background and elevated level of psychological distress. Participants will be randomized to care as usual only or to care a usual plus a guided self-help stress management guide (Doing What Matters in Times of Stress, DWM) and a five-session cognitive behavioral intervention (Problem Management Plus, PM+). Participants will self-report all measures at baseline before random allocation, 2 weeks after DWM delivery, 1 week after PM+ delivery and 2 months after PM+ delivery. All participants will receive a single-session of a support intervention, namely Psychological First Aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire-Anxiety and Depression Scale summary score 2 months after PM+ delivery. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, resource utilization, cost, and cost-effectiveness. Discussion: This study is the first randomized controlled trial that combines two World Health Organization psychological interventions tailored for migrant populations with an elevated level of psychological distress. The present study will make available DWM/PM+ packages adapted for remote delivery following a task-shifting approach, and will generate evidence to inform policy responses based on a more efficient use of resources for improving resilience, wellbeing and mental health. Clinical trial registration: ClinicalTrials.gov, identifier: NCT04993534.

Risk factors for mental disorder development in asylum seekers and refugees resettled in Western Europe and Turkey: Participant-level analysis of two large prevention studies.

BACKGROUND: In asylum seekers and refugees, the frequency of mental disorders, such as depression, anxiety and post-traumatic stress disorder, is higher than the general population, but there is a lack of data on risk factors for the development of mental disorders in this population. AIM: This study investigated the risk factors for mental disorder development in a large group of asylum seekers and refugees resettled in high- and middle-income settings. METHODS: Participant-level data from two randomized prevention studies involving asylum seekers and refugees resettled in Western European countries and in Turkey were pooled. The two studies randomized participants with psychological distress, but without a diagnosis of mental disorder, to the Self-Help Plus psychological intervention or enhanced care as usual. At baseline, exposure to potentially traumatic events was measured using the Harvard Trauma Questionnaire-part I, while psychological distress and depressive symptoms were assessed with the General Health Questionnaire and the Patient Health Questionnaire. After 3 and 6 months of follow-up, the proportion of participants who developed a mental disorder was calculated using the Mini International Neuropsychiatric Interview. RESULTS: A total of 1,101 participants were included in the analysis. At 3- and 6-month follow-up the observed frequency of mental disorders was 13.51% (115/851) and 24.30% (207/852), respectively, while the frequency estimates after missing data imputation were 13.95% and 23.78%, respectively. After controlling for confounders, logistic regression analysis showed that participants with a lower education level (p = .034), a shorter duration of journey (p = .057) and arriving from countries with war-related contexts (p = .017), were more at risk of developing mental disorders. Psychological distress (p = .004), depression (p = .001) and exposure to potentially traumatic events (p = .020) were predictors of mental disorder development. CONCLUSIONS: This study identified several risk factors for the development of mental disorders in asylum seekers and refugees, some of which may be the target of risk reduction policies. The identification of asylum seekers and refugees at increased risk of mental disorders should guide the implementation of focused preventative psychological interventions.

Trajectories of psychosocial symptoms and wellbeing in asylum seekers and refugees exposed to traumatic events and resettled in Western Europe, Turkey, and Uganda.

Background: Longitudinal studies examining mental health trajectories in refugees and asylum seekers are scarce. Objectives: To investigate trajectories of psychological symptoms and wellbeing in refugees and asylum seekers, and identify factors associated with these trajectories. Method: 912 asylum seekers and refugees from the control arm of three trials in Europe (n = 229), Turkey (n = 320), and Uganda (n = 363) were included. We described trajectories of psychological symptoms and wellbeing, and used trauma exposure, age, marital status, education, and individual trial as predictors. Then, we assessed the bidirectional interactions between wellbeing and psychological symptoms, and the effect of each predictor on each outcome controlling for baseline values. Results: Symptom improvement was identified in all trials, and for wellbeing in 64.7% of participants in Europe and Turkey, versus 31.5% in Uganda. In Europe and Turkey domestic violence predicted increased symptoms at post-intervention (ß = 1.36, 95% CI 0.17-2.56), whilst murder of family members at 6-month follow-up (ß = 1.23, 95% CI 0.27-2.19). Lower wellbeing was predicted by murder of family member (ß = -1.69, 95% CI -3.06 to -0.32), having been kidnapped (ß = -1.67, 95% CI -3.19 to -0.15), close to death (ß = -1.38, 95% CI -2.70 to -0.06), and being in the host country ≥2 years (ß = -1.60, 95% CI -3.05 to -0.14). In Uganda at post-intervention, having been kidnapped predicted increased symptoms (ß = 2.11, 95% CI 0.58-3.65), and lack of shelter (ß = -2.51, 95% CI -4.44 to -0.58) and domestic violence predicted lower wellbeing (ß = -1.36, 95% CI -2.67 to -0.05). Conclusion: Many participants adapt to adversity, but contextual factors play a critical role in determining mental health trajectories.

Antecedentes: Estudios longitudinales que examinan las trayectorias de la salud mental en los refugiados y solicitantes de asilo son escasos.Objetivos: Investigar las trayectorias de los síntomas psicológicos y el bienestar en refugiados y solicitantes de asilo, e identificar factores asociados a estas trayectorias.Métodos: Se incluyeron 912 solicitantes de asilos y refugiados del brazo control de tres ensayos clínicos en Europa (n = 229), Turquía (n = 320) y Uganda (n = 363). Describimos las trayectorias psicológicas de los síntomas y el bienestar, y utilizamos la exposición traumática, la edad, el estado marital, la educación y el juicio individual como predictores. Después, evaluamos las interacciones bidireccionales entre el bienestar y los síntomas psicológicos, y el efecto de cada uno de los predictores en cada resultado controlando por los valores iniciales.Resultados: Se identificó una mejoría en los síntomas en todos los ensayos, y del bienestar en el 64.7% de los participantes en Europa y Turquía, versus el 31.5% en Uganda. En Europa y en Turquía, la violencia doméstica predijo el incremento de síntomas de después de la intervención (ß = 1.36, 95% CI 0.17 a 2.56), mientras que el homicidio de algún miembro familiar a los 6 meses de seguimiento (ß = 1.23, 95% CI 0.27 a 2.19). Un menor bienestar fue predicho por el homicidio de algún miembro de la familia (ß = −1.69, 95% CI −3.06 a −0.32), haber sido secuestrado (ß = −1.67, 95% CI −3.19 a −0.15), haber estado próximo a la muerte (ß = −1.38, 95% CI −2.70 a −0.06), y estar en el país de acogida ≥2 años (ß = −1.60, 95% CI −3.05 a −0.14). En Uganda, después de la intervención, haber sido secuestrado predijo un aumento de los síntomas (ß =2.11, 95% CI 0.58 a 3.65), y la falta de refugio (ß = −2.51, 95% CI −4.44 a −0.58) y la violencia doméstica predijo un menor bienestar (ß = −1.36, 95% CI −2.67 a −0.05).Conclusión: Muchos participantes se adaptan a la adversidad, pero los factores contextuales juegan un papel crítico en determinar las trayectorias de la salud mental.

A Practical Framework for Academics to Implement Public Engagement Interventions and Measure Their Impact.

Academic institutions have shown an increased interest in the so-called third mission to offer an impactful contribution to society. Indeed, public engagement programs ensure knowledge transfer and help to inspire positive public discourse. We aimed to propose a comprehensive framework for academic institutions planning to implement a public engagement intervention and to suggest potential indicators to measure its impact. To inform the framework development, we searched the literature on public engagement, the third mission, and design theory in electronic databases and additional sources (e.g., academic recommendations) and partnered with a communication agency offering non-academic advice. In line with this framework, we designed a public engagement intervention to foster scientific literacy in Italian youth, actively involving them in the development of the intervention. Our framework is composed of four phases (planning/design, implementation, immediate impact assessment, and medium- and long-term assessment). Impact indicators were subdivided into outcome variables that were immediately describable (e.g., changed understanding and awareness of the target population) and measurable only in the medium or long run (e.g., adoption of the intervention by other institutions). The framework is expected to maximize the impact of public engagement interventions and ultimately lead to better reciprocal listening and mutual understanding between academia and the public.

Continuing, reducing, switching, or stopping antipsychotics in individuals with schizophrenia-spectrum disorders who are clinically stable: a systematic review and network meta-analysis.

BACKGROUND: Although antipsychotic maintenance treatment is widely recommended to prevent relapse in chronic psychoses, evidence-based guidelines do not provide clear indications on different maintenance treatment strategies, including continuing the antipsychotic at standard doses, reducing the dose, switching to another antipsychotic, or even stopping the antipsychotic. We aimed to compare the effectiveness of these maintenance treatment strategies, hypothesising the superiority of all strategies over stopping, and of continuing at standard doses over both switching and reducing the dose. METHODS: We did a systematic review and network meta-analysis of randomized controlled trials (RCTs) that investigated antipsychotics for relapse prevention in adults with schizophrenia-spectrum disorders who were clinically stable, and which compared four treatment strategies: continuing the current antipsychotic at standard doses recommended for acute treatment; reducing the current antipsychotic dose; switching to a different antipsychotic; and stopping the antipsychotic and replacing it with placebo. We excluded RCTs with fewer than 25 individuals, a prerandomisation washout period greater than 4 weeks, a follow-up shorter than 6 weeks, and those recruiting treatment-resistant individuals. We searched MEDLINE, EMBASE, PsycINFO, CINAHL, CENTRAL, and online trial registers for published and unpublished RCTs from inception to Sept 1, 2021, combining terms describing all available antipsychotics, and terms describing continuation, maintenance, or long-term treatment for schizophrenia-spectrum disorders. Relative risks (RRs) and standardised mean differences were pooled using random-effects pairwise and network meta-analyses. We assessed risk of bias of each RCT with the Cochrane Risk-of-Bias 2 tool, and confidence of pooled estimates with CINeMA. The primary outcome was relapse prevention. The study protocol was registered in advance in the Open Science Forum registry. FINDINGS: Of 3936 records identified, 119 records, reporting on 101 RCTs, were eligible, 98 of which (including 13 988 individuals) provided data that could be meta-analysed for at least one outcome. The mean proportion of female participants per study was 38% (range 0-100; median 39%, IQR 29-50), whereas for male participants it was 62% (range 0-100; median 61%, IQR 50-71), and the overall mean age was 38·8 years (range 23·2-63·9; median 39·3, IQR 35·0-43·9). Of the 98 RCTs meta-analysed, 89·8% were done in high-income and upper-middle-income countries. The ethnic group White or so-called Caucasian was the most represented (mean 56% participants per study), although this information was relatively scarce. All continuation strategies were significantly more effective in preventing relapse than stopping antipsychotic treatment, with a large risk reduction for continuing at standard doses (RR 0·37, 95% CI 0·32-0·43; number-needed-to-treat [NNT] 3·17, 95% CI 2·94-3·51) and antipsychotic switching (RR 0·44, 0·37-0·53; NNT 3·57, 3·17-4·25), and moderate risk reduction for dose reduction (RR 0·68, 0·51-0·90; NNT 6·25, 4·08-20·00). Continuing and switching antipsychotics did not differ significantly (RR 0·84, 0·69-1·02; with lower values favouring continuing), whereas reducing antipsychotic dose was outperformed by both continuing (RR 0·55, 0·42-0·71; NNT 4·44, 3·45-6·90) and switching (RR 0·65, 0·47-0·89; NNT 5·17, 3·77-18·18). Results were supported by moderate confidence of evidence and confirmed by secondary analyses and by several sensitivity and subgroup analyses, including removing studies with abrupt antipsychotic discontinuation or fast tapering (≤4 weeks). No tolerability differences emerged between treatment strategies. According to the Cochrane Risk-of-Bias tool, version 2, 16·8% of included RCTs had an overall high risk of bias for the primary outcome. We found moderate heterogeneity (τ2=0·13; I2=61%) and no overall incoherence for the primary analysis. Results were supported by moderate confidence of evidence and confirmed by secondary analyses. INTERPRETATION: Contrary to our original hypothesis, we found that continuing antipsychotic treatment at standard doses or switching to a different antipsychotic are similarly effective treatment strategies, whereas reducing antipsychotic doses below standard doses is associated with higher risk of relapse than the other two maintenance treatment strategies and should therefore be limited to selected cases. Despite limitations, including moderate heterogeneity and moderate certainty of evidence, these results are of pragmatic relevance for clinicians, and should support the update of evidence-based guidelines. FUNDING: None.

Cost-effectiveness of the Self-Help Plus Intervention for Adult Syrian Refugees Hosted in Turkey.

Importance: The cost-effectiveness of the Self-Help Plus (SH+) program, a group-based, guided, self-help psychological intervention developed by the World Health Organization for people affected by adversity, is unclear. Objective: To investigate the cost-utility of providing the SH+ intervention combined with enhanced usual care vs enhanced usual care alone for Syrian refugees or asylum seekers hosted in Turkey. Design, Setting, and Participants: This economic evaluation was performed as a prespecified part of an assessor-blinded randomized clinical trial conducted between October 1, 2018, and November 30, 2019, with 6-month follow-up. A total of 627 adults with psychological distress but no diagnosed psychiatric disorder were randomly assigned to the intervention group or the enhanced usual care group. Interventions: The SH+ program was a 5-session (2 hours each), group-based, stress management course in which participants learned self-help skills for managing stress by listening to audio sessions. The SH+ sessions were facilitated by briefly trained, nonspecialist individuals, and an illustrated book was provided to group members. Th intervention group received the SH+ intervention plus enhanced usual care; the control group received only enhanced usual care from the local health care system. Enhanced usual care included access to free health care services provided by primary and secondary institutions plus details on nongovernmental organizations and freely available mental health services, social services, and community networks for people under temporary protection of Turkey and refugees. Main Outcomes and Measures: The primary outcome measure was incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the Turkish health care system. An intention-to-treat analysis was used including all participants who were randomized and for whom baseline data on costs and QALYs were available. Data were analyzed September 30, 2020, to July 30, 2021. Results: Of 627 participants (mean [SD] age, 31.3 [9.0] years; 393 [62.9%] women), 313 were included in the analysis for the SH+ group and 314 in the analysis for the enhanced usual care group. An incremental cost-utility ratio estimate of T£6068 ($1147) per QALY gained was found when the SH+ intervention was provided to groups of 10 Syrian refugees. At a willingness to pay per QALY gained of T£14 831 ($2802), the SH+ intervention had a 97.5% chance of being cost-effective compared with enhanced usual care alone. Conclusions and Relevance: This economic evaluation suggests that implementation of the SH+ intervention compared with enhanced usual care alone for adult Syrian refugees or asylum seekers hosted in Turkey is cost-effective from the perspective of the Turkish health care system when both international and country-specific willingness-to-pay thresholds were applied.

Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial.

Refugees are at high risk of developing mental disorders. There is no evidence from randomized controlled trials (RCTs) that psychological interventions can prevent the onset of mental disorders in this group. We assessed the effectiveness of a self-help psychological intervention developed by the World Health Organization, called Self-Help Plus, in preventing the development of mental disorders among Syrian refugees experiencing psychological distress in Turkey. A two-arm, assessor-masked RCT was conducted in two Turkish areas. Eligible participants were adult Syrian refugees experiencing psychological distress (General Health Questionnaire ≥3), but without a diagnosis of mental disorder. They were randomly assigned either to the Self-Help Plus arm (consisting of Self-Help Plus combined with Enhanced Care as Usual, ECAU) or to ECAU only in a 1:1 ratio. Self-Help Plus was delivered in a group format by two facilitators over five sessions. The primary outcome measure was the presence of any mental disorder assessed by the Mini International Neuropsychiatric Interview at six-month follow-up. Secondary outcome measures were the presence of mental disorders at post-intervention, and psychological distress, symptoms of post-traumatic stress disorder and depression, personally identified psychological outcomes, functional impairment, subjective well-being, and quality of life at post-intervention and six-month follow-up. Between October 1, 2018 and November 30, 2019, 1,186 refugees were assessed for inclusion. Five hundred forty-four people were ineligible, and 642 participants were enrolled and randomly assigned to either Self-Help Plus (N=322) or ECAU (N=320). Self-Help Plus participants were significantly less likely to have any mental disorders at six-month follow-up compared to the ECAU group (21.69% vs. 40.73%; Cramer's V = 0.205, p<0.001, risk ratio: 0.533, 95% CI: 0.408-0.696). Analysis of secondary outcomes suggested that Self-Help Plus was not effective immediately post-intervention, but was associated with beneficial effects at six-month follow-up in terms of symptoms of depression, personally identified psychological outcomes, and quality of life. This is the first prevention RCT ever conducted among refugees experiencing psychological distress but without a mental disorder. Self-Help Plus was found to be an effective strategy for preventing the onset of mental disorders. Based on these findings, this low-intensity self-help psychological intervention could be scaled up as a public health strategy to prevent mental disorders in refugee populations exposed to ongoing adversities.

Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial.

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.

A network meta-analysis of psychosocial interventions for refugees and asylum seekers with PTSD.

INTRODUCTION: Refugees and asylum seekers are vulnerable to common mental disorders, including post-traumatic stress disorder (PTSD). Using a network meta-analysis (NMA) approach, the present systematic review compared and ranked psychosocial interventions for the treatment of PTSD in adult refugees and asylum seekers. METHODS: Randomised studies of psychosocial interventions for adult refugees and asylum seekers with PTSD were systematically identified. PTSD symptoms at postintervention was the primary outcome. Standardised mean differences (SMDs) and ORs were pooled using pairwise and NMA. Study quality was assessed with the Cochrane Risk of Bias (RoB) tool, and certainty of evidence was assessed through the Confidence in Network Meta-Analysis application. RESULTS: A total of 23 studies with 2308 participants were included. Sixteen studies were conducted in high-income countries, and seven in low-income or middle-income countries. Most studies were at low risk of bias according to the Cochrane RoB tool. NMA on PTSD symptoms showed that cognitive behavioural therapy (CBT) (SMD=-1.41; 95% CI -2.43 to -0.38) and eye movement desensitisation and reprocessing (EMDR) (SMD=-1.30; 95% CI -2.40 to -0.20) were significantly more effective than waitlist (WL). CBT was also associated with a higher decrease in PTSD symptoms than treatment as usual (TAU) (SMD -1.51; 95% CI -2.67 to -0.36). For all other interventions, the difference with WL and TAU was not significant. CBT and EMDR ranked best according to the mean surface under the cumulative ranking. Regarding acceptability, no intervention had less dropouts than inactive interventions. CONCLUSION: CBT and EMDR appeared to have the greatest effects in reducing PTSD symptoms in asylum seekers and refugees. This evidence should be considered in guidelines and implementation packages to facilitate dissemination and uptake in refugee settings.

Maintenance Treatment With Long-Acting Injectable Antipsychotics for People With Nonaffective Psychoses: A Network Meta-Analysis.

OBJECTIVE: This study compared relapse prevention and acceptability of long-acting injectable (LAI) antipsychotics in the maintenance treatment of adults with nonaffective psychoses. METHODS: The authors searched MEDLINE, Embase, PsycINFO, CINAHL, CENTRAL, and online registers for randomized controlled trials published until June 2020. Relative risks and standardized mean differences were pooled using random-effects pairwise and network meta-analysis. The primary outcomes were relapse rate and all-cause discontinuation ("acceptability"). The quality of included studies was rated with the Cochrane Risk of Bias tool, and the certainty of pooled estimates was measured with GRADE (Grading of Recommendations Assessment, Development, and Evaluation). RESULTS: Of 86 eligible trials, 78 (N=11,505) were included in the meta-analysis. Regarding relapse prevention, most of the 12 LAIs included outperformed placebo. The largest point estimates and best rankings of LAIs compared with placebo were found for paliperidone (3-month formulation) and aripiprazole. Moderate to high GRADE certainty for superior relapse prevention compared with placebo was also found for (in descending ranking order) risperidone, pipothiazine, olanzapine, and paliperidone (1-month formulation). In head-to-head comparisons of LAIs, only haloperidol was inferior to aripiprazole, fluphenazine, and paliperidone. For acceptability, most LAIs outperformed placebo, with moderate to high GRADE certainty for (in descending ranking order) zuclopenthixol, aripiprazole, paliperidone (3-month formulation), olanzapine, flupenthixol, fluphenazine, and paliperidone (1-month formulation). In head-to-head comparisons, only LAI aripiprazole had superior acceptability to other LAIs (bromperidol, fluphenazine, paliperidone [1-month formulation], pipothiazine, and risperidone). CONCLUSIONS: LAI formulations of paliperidone (3-month formulation), aripiprazole, olanzapine, and paliperidone (1-month formulation) showed the highest effect sizes and certainty of evidence for both relapse prevention and acceptability. Results from this network meta-analysis should inform frontline clinicians and guidelines.

Efficacy of interventions to reduce coercive treatment in mental health services: umbrella review of randomised evidence.

BACKGROUND: Coercive treatment comprises a broad range of practices, ranging from implicit or explicit pressure to accept certain treatment to the use of forced practices such as involuntary admission, seclusion and restraint. Coercion is common in mental health services. AIMS: To evaluate the strength and credibility of evidence on the efficacy of interventions to reduce coercive treatment in mental health services. Protocol registration: https://doi.org/10.17605/OSF.IO/S76T3. METHOD: Systematic literature searches were conducted in MEDLINE, Cochrane Central, PsycINFO, CINAHL, Campbell Collaboration, and Epistemonikos from January 2010 to January 2020 for meta-analyses of randomised studies. 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 classified using quantitative umbrella review criteria, and credibility of evidence was assessed using the GRADE approach. RESULTS: A total of 23 primary studies (19 conducted in European countries and 4 in the USA) enrolling 8554 participants were included. The evidence on the efficacy of staff training to reduce use of restraint was supported by the most robust evidence (relative risk RR = 0.74, 95% CI 0.62-0.87; suggestive association, GRADE: moderate), followed by evidence on the efficacy of shared decision-making interventions to reduce involuntary admissions of adults with severe mental illness (RR = 0.75, 95% CI 0.60-0.92; weak association, GRADE: moderate) and by the evidence on integrated care interventions (RR = 0.66, 95% CI 0.46-0.95; weak association, GRADE: low). By contrast, community treatment orders and adherence therapy had no effect on involuntary admission rates. CONCLUSIONS: Different levels of evidence indicate the benefit of staff training, shared decision-making interventions and integrated care interventions to reduce coercive treatment in mental health services. These different levels of evidence should be considered in the development of policy, clinical and implementation initiatives to reduce coercive practices in mental healthcare, and should lead to further studies in both high- and low-income countries to improve the strength and credibility of the evidence base.

Safety of Psychotropic Medications in People With COVID-19: Evidence Review and Practical Recommendations.

(Reprinted with permission from the BMC Medicine (2020) 18:215).

Association of traumatic events with levels of psychological distress and depressive symptoms in male asylum seekers and refugees resettled in Italy.

BACKGROUND: 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, public health and mental health implications. The aim of this study is to (1) describe the level of psychological distress and frequency of psychiatric disorders in a sample of male asylum seekers and refugees across different ethnic groups resettled in Italy; (2) establish whether the number of traumatic events experienced before, during and after the migration process is associated with level of psychological distress and depressive symptoms. METHODS: In two large Italian catchment areas, over a period of 1 year a consecutive series of male asylum seekers and refugees, aged 18 or above and included in the Italian protection system, were screened for psychological distress and psychiatric disorders using validated questionnaires. RESULTS: During the study period, 252 male asylum seekers or refugees were recruited. More than one-third of the participants (34.5%) showed clinically relevant psychological distress, and one-fourth (22.2%), met the criteria for a psychiatric diagnosis, mainly Post Traumatic Stress Disorder and depressive disorders. The number of traumatic events turned out to be a risk factor for both clinically relevant psychological distress and depressive disorders. Receiving good social support emerged as a protective factor, while migrants with unclear status were at higher risk of psychological distress than those holding or awaiting a permission. DISCUSSION: In an unselected sample of male asylum seekers and refugees, after around 1 year of resettlement in Italy, the frequency of psychological distress and psychiatric disorders was substantial and clinically relevant. The association between traumatic events, especially post-migration problems, and mental health conditions suggests the need of developing services to assist refugees and asylum seekers to address the multi-faceted problems they experience, such as social support in host country, legal problems concerning permit status and asylum procedure, and family reunification, as well as addressing trauma and mental health issues.

Correction to: Safety of psychotropic medications in people with COVID-19: evidence review and practical recommendations.

An amendment to this paper has been published and can be accessed via the original article.

Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial.

INTRODUCTION: Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome. METHODS AND ANALYSIS: This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled. ETHICS AND DISSEMINATION: This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants' data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03779789 , Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018-001444-66. TRIAL STATUS: Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.

Safety of psychotropic medications in people with COVID-19: evidence review and practical recommendations.

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.

Efficacy of psychosocial interventions for mental health outcomes in low-income and middle-income countries: an umbrella review.

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.

Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials.

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.

Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy.

BACKGROUND: For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, and to explore possible prescribing differences between first- and second-generations LAIs under ordinary clinical practice in Italy. METHODS: The STAR Network "Depot" Study is an observational, longitudinal, multicenter study involving 35 centers in Italy. In the cross-sectional phase, patients prescribed with LAIs were consecutively recruited and assessed over a period of 12 months. Descriptive statistics and multivariable logistic regression analyses were employed. RESULTS: Of the 451 recruited patients, 61% were males. The level of social and working functioning was heterogeneous, as was the severity of disease. Seventy-two per cent of the patients had a diagnosis of the schizophrenia spectrum. Seventy per cent were prescribed with second-generation antipsychotic (SGA) LAIs (mostly paliperidone, aripiprazole and risperidone). Compared to first-generation antipsychotic (FGA) LAIs, patients prescribed with SGA LAIs were more often younger; employed; with a diagnosis of the schizophrenia spectrum or bipolar disorder; with higher levels of affective symptoms; with fewer LAI prescriptions in the past. DISCUSSION: LAIs' prescribing practices appear to be more flexible as compared to the past, although this change is mostly restricted to SGA LAIs.