Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial.

Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

Microaggression toward LGBTIQ people and implications for mental health: A systematic review.

BACKGROUND: Research suggests that microaggressions detrimentally impact the mental health of members of marginalized social groups. AIMS: The aim of this systematic review was to assess the exposure to microaggressions and related implications on mental health of Lesbian, Gay, Bisexual, Transgender, Intersex, and Queer (LGBTIQ) people. METHOD: Medline, Scopus, PsycINFO, CINAHL, and EMBASE were searched until January 2023. Studies reporting data on the exposure to microaggressions toward LGBTIQ people were identified. Meta-analyses of rates of exposure to microaggression and of the association between microaggressions and mental health outcomes were based on odds ratio (OR) and standardized mean difference (SMD) with 95% confidence intervals (95% CI), estimated through inverse variance models with random effects. RESULTS: The review process led to the selection of 17 studies, involving a total of 9036 LGBTIQ people, of which 6827 identifying as cisgenders, and 492 as heterosexuals, were included in the quantitative synthesis. Overall, LGBTIQ people showed an increased risk of microaggression (SMD: 0.89; 95% CI [0.28, 1.50]), with Transgender people having the highest risk (OR: 10.0; 95% CI [3.08, 32.4]). Microaggression resulted associated with risk of depression (SMD: 0.21; 95% CI [0.05, 0.37]), anxiety (SMD: 0.29; 95% CI [0.17, 0.40]), suicide attempts (OR: 1.13; 95% CI [1.08, 1.18]), alcohol abuse (OR: 1.32; 95% CI [1.13, 1.54]), but not to suicidal ideation (OR: 1.56; 95% CI [0.64, 3.81]) and cannabis abuse (OR: 1.44; 95% CI [0.82, 2.55]). The quality of the evidence was limited by the small number of studies. CONCLUSIONS: LGBTIQ people are at higher risk of microaggressions compared with their cisgender/heterosexual peers, which may lead to mental health consequences. This evidence may contribute to public awareness of LGBTIQ mental health needs and suggest supportive strategies as well as preventive interventions (e.g., supportive programs and destigmatizing efforts) as parts of tailored health-care planning aimed to reduce psychiatric morbidity in this population.

Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.

BACKGROUND: There is a significant research gap in the field of universal, selective, and indicated prevention interventions for mental health promotion and the prevention of mental disorders. Barriers to closing the research gap include scarcity of skilled human resources, large inequities in resource distribution and utilization, and stigma. OBJECTIVES: To assess the effectiveness of delivery by primary workers of interventions for the promotion of mental health and universal prevention, and for the selective and indicated prevention of mental disorders or symptoms of mental illness in low- and middle-income countries (LMICs). To examine the impact of intervention delivery by primary workers on resource use and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Global Index Medicus, PsycInfo, WHO ICTRP, and ClinicalTrials.gov from inception to 29 November 2021. SELECTION CRITERIA: Randomized controlled trials (RCTs) of primary-level and/or community health worker interventions for promoting mental health and/or preventing mental disorders versus any control conditions in adults and children in LMICs. DATA COLLECTION AND ANALYSIS: Standardized mean differences (SMD) or mean differences (MD) were used for continuous outcomes, and risk ratios (RR) for dichotomous data, using a random-effects model. We analyzed data at 0 to 1, 1 to 6, and 7 to 24 months post-intervention. For SMDs, 0.20 to 0.49 represented small, 0.50 to 0.79 moderate, and ≥ 0.80 large clinical effects. We evaluated the risk of bias (RoB) using Cochrane RoB2. MAIN RESULTS: Description of studies We identified 113 studies with 32,992 participants (97 RCTs, 19,570 participants in meta-analyses) for inclusion. Nineteen RCTs were conducted in low-income countries, 27 in low-middle-income countries, 2 in middle-income countries, 58 in upper-middle-income countries and 7 in mixed settings. Eighty-three RCTs included adults and 30 RCTs included children. Cadres of primary-level workers employed primary care health workers (38 studies), community workers (71 studies), both (2 studies), and not reported (2 studies). Interventions were universal prevention/promotion in 22 studies, selective in 36, and indicated prevention in 55 RCTs. Risk of bias The most common concerns over risk of bias were performance bias, attrition bias, and reporting bias. Intervention effects 'Probably', 'may', or 'uncertain' indicates 'moderate-', 'low-', or 'very low-'certainty evidence. *Certainty of the evidence (using GRADE) was assessed at 0 to 1 month post-intervention as specified in the review protocol. In the abstract, we did not report results for outcomes for which evidence was missing or very uncertain. Adults Promotion/universal prevention, compared to usual care: - probably slightly reduced anxiety symptoms (MD -0.14, 95% confidence interval (CI) -0.27 to -0.01; 1 trial, 158 participants) - may slightly reduce distress/PTSD symptoms (SMD -0.24, 95% CI -0.41 to -0.08; 4 trials, 722 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD -0.69, 95% CI -1.08 to -0.30; 4 trials, 223 participants) Indicated prevention, compared to usual care: - may reduce adverse events (1 trial, 547 participants) - probably slightly reduced functional impairment (SMD -0.12, 95% CI -0.39 to -0.15; 4 trials, 663 participants) Children Promotion/universal prevention, compared to usual care: - may improve the quality of life (SMD -0.25, 95% CI -0.39 to -0.11; 2 trials, 803 participants) - may reduce adverse events (1 trial, 694 participants) - may slightly reduce depressive symptoms (MD -3.04, 95% CI -6 to -0.08; 1 trial, 160 participants) - may slightly reduce anxiety symptoms (MD -2.27, 95% CI -3.13 to -1.41; 1 trial, 183 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD 0, 95% CI -0.16 to -0.15; 2 trials, 638 participants) - may slightly reduce anxiety symptoms (MD 4.50, 95% CI -12.05 to 21.05; 1 trial, 28 participants) - probably slightly reduced distress/PTSD symptoms (MD -2.14, 95% CI -3.77 to -0.51; 1 trial, 159 participants) Indicated prevention, compared to usual care: - decreased slightly functional impairment (SMD -0.29, 95% CI -0.47 to -0.10; 2 trials, 448 participants) - decreased slightly depressive symptoms (SMD -0.18, 95% CI -0.32 to -0.04; 4 trials, 771 participants) - may slightly reduce distress/PTSD symptoms (SMD 0.24, 95% CI -1.28 to 1.76; 2 trials, 448 participants). AUTHORS' CONCLUSIONS: The evidence indicated that prevention interventions delivered through primary workers - a form of task-shifting - may improve mental health outcomes. Certainty in the evidence was influenced by the risk of bias and by substantial levels of heterogeneity. A supportive network of infrastructure and research would enhance and reinforce this delivery modality across LMICs.

Task-sharing psychosocial interventions for the prevention of common mental disorders in the perinatal period in low- and middle-income countries: A systematic review and meta-analysis.

AIM: to assess the efficacy of psychosocial interventions delivered through task-sharing approaches for preventing perinatal common mental disorders among women in low- and middle-income countries. METHODS: We conducted a systematic review of randomized controlled trials following a prespecified protocol registered in the Open Science Framework (osf.io/qt4y3). We searched MEDLINE, Web of Science, PsycINFO, and Cochrane Central Register of Controlled Trials (CENTRAL) through June 2022. Two reviewers independently extracted the data and evaluated the risk of bias of included studies using the Cochrane risk of bias tool. We performed random-effects meta-analyses and rated the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: We included 23 studies with 24,442 participants. At post-intervention, task-shared psychosocial interventions, were effective in preventing the development of mental disorders in general (RR 0.57, 95% CI [0.35, 0.91]), and specifically depression (RR 0.51, 95% CI [0.35, 0.75]), but not anxiety disorders (RR 0.46, 95% CI [0.06, 3.33]). Similarly, psychosocial interventions reduced psychological distress (SMD -1.32, 95% CI [-2.28, -0.35]), and depressive symptoms (SMD -0.50, 95% CI [-0.80, -0.16]), and increased parenting self-efficacy (SMD -0.76, 95% CI [-1.13, -0.38]) and social support (SMD -0.72, 95% CI [-1.22, -0.22]). No effect was detected for anxiety symptoms at post-intervention. At follow-up the beneficial effects of interventions progressively decreased. CONCLUSIONS: Psychosocial interventions delivered through the task-sharing modality are effective in preventing perinatal common mental disorders and fostering positive mental health among women in low- and middle-income countries. However, our findings are tentative, due to the low number of preventative intervention strategies considering outcomes as the incidence of mental disorders, especially in the long-term. This evidence supports calls to implement and scale up psychosocial prevention interventions for perinatal common mental disorders in low- and middle-income countries.

Changes in emergency psychiatric consultations in time of COVID-19: a retrospective observational study in the Verona Academic Hospital over the two pandemic years 2020-2021.

BACKGROUND: During the first months of the COVID-19 pandemic, local health authorities in most Italian regions prescribed a reduction of ordinary outpatient and community mental health care. The aim of this study was to assess the impact of the COVID-19 pandemic on access to the emergency departments (ED) for psychiatric consultation in the pandemic years 2020 and 2021 compared to 2019. METHODS: This is a retrospective study conducted by using routinely collected administrative data of the two EDs of the Verona Academic Hospital Trust (Verona, Italy). All ED psychiatry consultations registered from 01.01.2020 to 31.12.2021 were compared with those registered in the pre-pandemic year (01.01.2019 to 31.12.2019). The association between each recorded characteristic and the year considered was estimated by chi-square or Fisher's exact test. RESULTS: A significant reduction was observed between 2020 and 2019 (-23.3%) and between 2021 and 2019 (-16.3%). This reduction was most evident in the lockdown period of 2020 (-40.3%) and in the phase corresponding to the second and third pandemic waves (-36.1%). In 2021, young adults and people with diagnosis of psychosis showed an increase in requests for psychiatric consultation. CONCLUSIONS: Fear of contagion may have been an important factor in the overall reduction in psychiatric consultations. However, psychiatric consultations for people with psychosis and for young adults increased. This finding underlines the need for mental health services to implement alternative outreach strategies aimed to support, in times of crisis, these vulnerable segments of the population.

Mental health in transgender individuals: a systematic review.

Several lines of evidence indicate the prevalence of mental health disorders in Transgender (TG) individuals is higher than that of cisgender individuals or the general population. In this systematic review, we aim to propose a summary of some of the most significant research investigating mental health disorders' prevalence among this population. We performed a double-blind systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting (PRISMA) on PUBMED/MEDLINE and SCOPUS, specifically using peer-reviewed articles examining the mental health status of transgender (TG) individuals. This review did not exclude any research based on publication date. The last search was performed in February 2022. The employed search strategy led to the selection of 165 peer-reviewed articles. The majority of these papers presented a cross-sectional design with self-reported diagnoses and symptoms, signaling a significant prevalence of mental health disorders amongst TG Individuals. Of the reviewed articles, 72 examined the prevalence of mood and anxiety disorders; 8 examined eating disorders; 43 examined the prevalence of suicidal or self-harm ideation or behaviors; 5 papers examined the prevalence of trauma and stress-related disorders; 10 examined the frequency of personality disorders; 44 examined substance use disorders; and 9 papers examined the prevalence of autism spectrum disorder. Finally, 22 studies reported on the prevalence of TG individuals diagnosed with co-morbid mental health disorders or unspecified mental disorders. Our findings coincide with existing research, which indicates TG individuals do experience a higher prevalence of mental health disorders than that of the general population or cisgender individuals. However, further research is needed to address the existing gaps in knowledge.

Mental health for LGBTQI people: a policies' review.

The mental health of lesbian, gay, bisexual, transgender, queer, intersexual (LGBTQI) individuals is significantly influenced by many factors such as difficulties in coming-out, poor acceptance, isolation and discrimination as well as minority-related stress. LGBTQI individuals, in fact, show a significant higher risk of mental health conditions, substance- use disorders and suicide. In addition, mental health services access may be difficult for personal and social barriers as well as a lack of adequate and specific mental health support. This review aims to assess and describe international policies, guidelines, position statements and recommendations regarding the promotion and protection of mental health rights for LGBTQI people. The search has been focussed on peer-reviewed papers, Governmental and Mental Health Association- Guidelines and Position Statements, Health Agencies - Guidelines and Position Statements (with a specific focus on mental health), LGBTQI Alliances and Foundations Publishing (with a specific focus on mental health). In addition, relevant international initiatives, and projects in the field of LGBTQI mental health will be described.

Barriers in care pathways and unmet mental health needs in LGBTIQ + communities.

Lesbian, gay, bisexual, transgender, intersex, queer people and minority gender identities and sexualities (LGBTIQ+) are often stigmatized and experience discrimination in health care settings, leading to poorer mental health outcomes and unmet needs compared to heterosexual and cisgendered peers. It is thus imperative that mental health providers consider and address structural challenges in order to reduce mental health inequalities of this population. This narrative review assessed the barriers that may prevent access to care and the pathways for care in LGBTIQ + communities. PubMed, PsycInfo, Embase, and Scopus were searched for papers published between December 2021 and February 2022. A total of 107 papers were included with studies reflecting five themes: (1) Unmet mental health needs; (2) Young people; (3) Substance abuse and addiction; (4) Barriers and pathways to care; and (5) Interventions. Findings demonstrate that LGBTIQ + people experience stigmatization and higher rates of substance misuse and mental ill health, which may lead to barriers in accessing health care services, and fewer tailored interventions being provided. These findings have implications for policy, health care screening, and how specialist services are structured. Substantial gaps in the evidence-base exist, and future research should examine how mental health care providers can challenge social issues that maintain discriminatory and stigmatizing practices, and support LGBTIQ + individuals to sustain their resilience.

Self-harm and suicidality among LGBTIQ people: a systematic review and meta-analysis.

Research evidence has consistently documented a higher risk of suicidality in the Lesbian, Gay, Bisexual, Transgender, Intersex, and Queer (LGBTIQ) population. This systematic review and meta-analysis aimed to report a detailed description of research data regarding the risk of Attempted Suicide (SA), Suicide Ideation (SI), and Non-Suicidal Self-Injury (NSSI) behaviours for LGBTIQ people and their subgroups. Medline, Scopus, PsycINFO, and EMBASE were searched for studies reporting a comparative estimation of SA, SI, and NSSI rates among LGBTIQ population and the general population (i.e. heterosexual/cisgender), without restrictions on participants' age and setting for the enrolment. Pooled analyses were based on odds ratios (ORs, with 95% CIs), estimated through inverse variance models with random effects. Fifty studies were selected for the quantitative synthesis and included fifty samples involving 3.735.601 controls and 87.252 LGBTIQ people. LGBTIQ people reported an increased risk of SA (OR:4.36[95%CI:3.32;5.71]), SI (OR:3.76[95%CI:3.02;4.69]), and NSSI (OR:4.24[95%CI:3.23;5.55]). Among LGBTIQ subgroups, the Bisexual group has shown the highest risk of suicidality (SA, OR:6.71; SI, OR:5.04; NSSI, OR: 5.03), followed by the Lesbian-Gay for attempted suicide (SA, OR:6.03), and the Transgender-Intersex-Queer for suicide ideation and non-suicidal self-injury (SI and NSSI, OR:3.42). The quality of the evidence ranged from low to moderate. Our findings have shown that LGBTIQ people report a higher risk of suicidality compared with their cisgender/heterosexual peers. This evidence may contribute to the public awareness on LGBTQI mental health needs and suggest supportive strategies as well as preventive interventions (e.g. supportive programs, counselling, and destigmatizing efforts) as parts of a tailored health-care planning aimed to reduce psychiatric morbidity and mortality in this at-risk population.

Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial.

BACKGROUND: Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. METHODS AND ANALYSIS: A parallel-group randomized controlled trial will assess the feasibility, acceptability, and efficacy of a mindfulness and compassion-focused programme on frontline nurses who had been working during the COVID-19 pandemic. Seventy-two participants will be recruited from Verona University Hospital Trust (Veneto Region, north-east Italy) and will be divided equally into an intervention group and a control group. Primary outcome will be assessed using the Emotional Exhaustion subscale of the Maslach Burnout Inventory General Survey (MBI-GS). Secondary outcomes will be measured by the Cynicism and Professional Efficacy subscales of the MBI-GS, the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder (GAD-7), the Insomnia Severity Index (ISI), the Impact of Stressful Events (IES-R), the Perceived Stress Scale (PSS), the Five Facet Mindfulness Questionnaire (FFMQ), and the Forms of Self-Criticising/attacking and Self-Reassuring Scale (FSCRS). DISCUSSION: The study aims to fill a gap in the literature and present a scientifically validated intervention for those healthcare professionals most exposed to the stressful conditions of working during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT05308537.

Suicide mortality among psychiatric patients in Northeast Italy: a 10-year cohort study.

AIMS: The present study investigated the relationship between suicide mortality and contact with a community mental health centre (CMHC) among the adult population in the Veneto Region (northeast Italy, population 4.9 million). Specifically, it estimated the effects of age, gender, time elapsed since the first contact with a CMHC, calendar year of diagnosis and diagnostic category on suicide mortality and modality. METHODS: The regional mortality archive was linked to electronic medical records for all residents aged 18-84 years who had been admitted to a CMHC in the Veneto Region in 2008. In total, 54 350 subjects diagnosed with a mental disorder were included in the cohort and followed up for a period of 10 years, ending in 2018. Years of life lost (YLL) were computed and suicide mortality was estimated as a mortality rate ratio (MRR). RESULTS: During the follow-up period, 4.4% of all registered deaths were from suicide, but, given the premature age of death (mean 52.2 years), suicide death accounted for 8.7% of YLL; this percentage was particularly high among patients with borderline personality disorder (27.2%), substance use disorder (12.1%) and bipolar disorder (11.5%) who also presented the highest suicide mortality rates. Suicide mortality rates were halved in female patients (MRR 0.45; 95% CI 0.37-0.55), highest in patients aged 45-54 years (MRR 1.56; 95% CI 1.09-2.23), and particularly elevated in the 2 months following first contact with CMHCs (MRR 10.4; 95% CI 5.30-20.3). A sensitivity analysis restricted to patients first diagnosed in 2008 confirmed the results. The most common modalities of suicide were hanging (47%), jumping (18%), poisoning (13%) and drowning (10%), whereas suicide from firearm was rare (4%). Gender, age at death and time since first contact with CMHCs influenced suicide modality. CONCLUSIONS: Suicide prevention strategies must be promptly initiated after patients' first contact with CMHCs. Patients diagnosed with borderline personality disorder, substance use disorder and bipolar disorder may be at particularly high risk for suicide.

The psychological impact of COVID-19 among primary care physicians in the province of Verona, Italy: a cross-sectional study during the first pandemic wave.

BACKGROUND: Among healthcare professionals working with COVID-19 patients, general practitioners (GPs) are under considerable pressure and may develop adverse mental health outcomes. OBJECTIVES: To assess mental health outcomes on GPs working during the COVID-19 pandemic and to explore their associations with personal characteristics and features of GP practices. METHODS: Observational cross-sectional study conducted on a sample of GPs working in Verona province (Italy) during the first pandemic wave. Participants were invited to complete a web-based form addressing socio-demographic and work-related information, previous practice organization, practice re-organization during the COVID-19 pandemic, and a set of measures for post-traumatic stress (IES-R), anxiety (SAS), depression (PHQ-9), and burnout (MBI-GS). RESULTS: A total of 215 GPs (38.3% of the eligible population) participated. Overall, 44.7% reported COVID-19-related traumatic events; among these, 35.9% (95% CI, 26%‒46%) developed symptoms of post-traumatic distress. Furthermore, 36% (95% CI, 29%‒43%) reported symptoms of anxiety, 17.9% (95% CI, 12%‒23%) symptoms of at least moderate depression, and 25.4% (95% CI, 19%‒32%) symptoms of burnout. Multivariate regressions showed that being quarantined or admitted for COVID-19 was associated with all the mental health outcomes considered. Being female, working in rural settings, and having less professional experience were associated with higher anxiety and depression. The ability to diagnose COVID-19 increased self-perceived professional efficacy, thus contributing to burnout reduction. CONCLUSION: The high prevalence of adverse mental health outcomes among GPs during the pandemic highlights the importance of timely interventions in this population and promoting targeted preventive actions in the event of future healthcare crises.

The Sustained Psychological Impact of the COVID-19 Pandemic on Health Care Workers One Year after the Outbreak-A Repeated Cross-Sectional Survey in a Tertiary Hospital of North-East Italy.

This study aimed to evaluate the mental health outcomes of health care workers (HCWs) of the Verona academic hospital trust (Italy) one year after the outbreak of COVID-19 and to identify predicted risk factors. A web-based survey was conducted from mid-April to mid-May 2021 on hospital workers one year after the first evaluation performed during the lock-down phase of the COVID-19 pandemic. Post-traumatic stress, general anxiety, depression, and burnout were assessed by using, respectively, the impact of event scale (IES-R), the self-rating anxiety scale (SAS), the patient health questionnaire (PHQ-9) and the Maslach burnout inventory-general survey (MBI-GS). Multivariate logistic regression analysis was performed to identify factors associated with each of the four mental health outcomes one year after the COVID-19 outbreak. A total of 1033 HCWs participated. The percentage of HCWs scoring above the cut-off increased from 2020 to 2021 in all of the outcome domains (anxiety, 50.1% vs. 55.7, p < 0.05; depression, 26.6% vs. 40.6%, p < 0.001; burnout, 28.6% vs. 40.6%, p < 0.001; chi-square test), with the exception of post-traumatic distress. There was also an increase when stratifying by occupation and workplace, with a greater increase for depression and burnout. Multivariate analysis revealed that, one year after the COVID-19 outbreak, nurses were at the greatest risk of anxiety and depression, whereas residents were at the greatest risk of burnout (in terms of low professional efficacy). Working in intensive care units was associated with an increased risk of developing severe emotional exhaustion and a cynical attitude towards work.

Causes of mortality in a large population-based cohort of psychiatric patients in Southern Europe.

The World Health Organization considers excess morbidity and mortality among people with mental disorders as a high public health priority. This study aims to estimate the mortality risk and causes of death among a large population-based cohort of psychiatric patients. All residents in Veneto (Northeastern Italy) aged between 18 and 84 years with a contact with Community Mental Health Centers in 2008 and a psychiatric diagnosis (n = 54,350) were followed-up for 10 years. Standardized Mortality Ratios (SMR) and excess mortality were computed, with the general regional population as a reference. Mortality was more than doubled (males SMR = 2.4; females SMR = 2.2) and the relative increase in mortality was much larger in young and middle-aged adults (18-44 and 45-64 years) across all diagnostic groups. The most frequent causes were circulatory diseases (27%) and neoplasms (26%). Although the risk was increased by about tenfold, deaths from suicide were limited to 6% and 4% of all decedents in males and females, respectively. Patients with schizophrenia showed a very high risk for mortality for diabetes and cardiovascular disorders. A large excess was found also for respiratory diseases and a two-fold increase for lung cancer in males and breast cancer in females. Although chronic physical disorders are known to be the main causes of mortality in such patients, they receive far less attention than suicide or accidents. Our results suggest that there is still a need to plan actions to prevent excess mortality and to improve the quality of life of patients with mental disorders.

Levels of burn-out among healthcare workers during the COVID-19 pandemic and their associated factors: a cross-sectional study in a tertiary hospital of a highly burdened area of north-east Italy.

OBJECTIVE: To determine burn-out levels and associated factors among healthcare personnel working in a tertiary hospital of a highly burdened area of north-east Italy during the COVID-19 pandemic. DESIGN: Observational study conducted from 21 April to 6 May 2020 using a web-based questionnaire. SETTING: Research conducted in the Verona University Hospital (Veneto, Italy). PARTICIPANTS: Out of 2195 eligible participants, 1961 healthcare workers with the full range of professional profiles (89.3%) completed the survey. PRIMARY OUTCOME MEASURE: Levels of burn-out, assessed by the Maslach Burnout Inventory-General Survey (MBI-GS). Multivariable logistic regression analysis was performed to identify factors associated with burn-out in each MBI-GS dimension (emotional exhaustion, EX; professional efficacy, EF; cynicism, CY). RESULTS: Overall, 38.3% displayed high EX, 46.5% low EF and 26.5% high CY. Burn-out was frequent among staff working in intensive care units (EX 57.0%; EF 47.8%; CY 40.1%), and among residents (EX 34.9%; EF 63.9%; CY 33.4%) and nurses (EX 49.2%; EF 46.9%; CY 29.7%). Being a resident increased the risk of burn-out (by nearly 2.5 times) in all the three MBI subscales and being a nurse increased the risk of burn-out in the EX dimension in comparison to physicians. Healthcare staff directly engaged with patients with COVID-19 showed more EX and CY than those working in non-COVID wards. Finally, the risk of burn-out was higher in staff showing pre-existing psychological problems, in those having experienced a COVID-related traumatic event and in those having experienced interpersonal avoidance in the workplace and personal life. CONCLUSIONS: Burn-out represents a great concern for healthcare staff working in a large tertiary hospital during the COVID-19 pandemic and its impact is more burdensome for front-line junior physicians. This study underlines the need to carefully address psychological well-being of healthcare workers to prevent the increase of burn-out in the event of a new COVID-19 healthcare emergency.

Instruments to evaluate mental well-being in old age: a systematic review.

OBJECTIVE: The aim of this study is to identify and appraise existing instruments to evaluate mental well-being in old age. METHOD: Systematic literature searches in PubMed, PsycINFO, ProQuest Research Library, AgeLine and CINAHL databases were performed. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline was used to assess the measurement properties, reported according to the Preferred Reporting Items for Systematic Reviews and meta-Analysis (PRISMA) statement. For each measurement property, results were classified as positive, negative or indeterminate. The quality level of evidence was rated as high, moderate, low or very low following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: A total of 28 instruments were found. Most instruments evaluated different dimensions of mental well-being, including various subscales. The quality was adequate overall. Six instruments showed high quality (Perceived Well-Being Scale-PWB, Salamon-Conte Life Satisfaction in the Elderly Scale-SCLSES, Herth Hope Scale-HHS, Life Satisfaction Index Third Age-LSITA, Meaning in Life Scale-MLS, and SODdisfazione dell'Anziano-SODA), and other six a moderate level (Scale of Happiness of the Memorial University of Newfoundland-MUNSH, Six Scales of Psychological Well-Being-PWBS, Valuation Of Life-VOL, Life Satisfaction Scale for Chinese Elders-LSS-C, Meaningful Activity Participation Assessment-MAPA and Will To Life-WTL). CONCLUSION: This review provides the first comprehensive synthesis of instruments assessing mental well-being in older populations. The PWB, SCLSES, HHS, LSITA, MLS and SODA were the most appropriated instruments. An instrument that specifically measures mental well-being in the oldest old age group (aged 80 plus) and that considers its multidimensional nature is needed.

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

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

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.