In ESCAPE-TRD, esketamine nasal spray (ESK-NS) significantly increased the probability of remission at Week (Wk)8 and being relapse‑free through Wk32 after remission at Wk8 versus (vs) quetiapine extended-release (QTP-XR), in patients (pts) with treatment resistant depression (TRD). Safety data were consistent with established profiles of each treatment, with no new safety signals identified (Reif et al. DGPPN 2022; P-01-04).

To explore weight changes and their impact on treatment discontinuation in ESCAPE-TRD.

ESCAPE‑TRD (NCT04338321) was a randomised, open-label, rater-blinded, phase IIIb trial comparing efficacy and safety of ESK-NS vs QTP-XR in pts with TRD. Safety analyses were conducted on pts who received ≥1 dose of study treatment. Treatment-emergent adverse events (TEAEs) were defined as occurring at or after the first dose of study treatment and within 14 days/30 days (non-serious/serious) of the last dose. A ≥7% increase/decrease in weight from screening was considered for evaluation as a TEAE. Weights were measured and are reported as observed, with no missing data imputation.

336 and 340 pts were randomised to ESK-NS and QTP-XR; 334 and 336 were included in the safety population. Over the 32-week study, a TEAE of weight increase was reported in fewer pts treated with ESK-NS than QTP-XR (9 [2.7%] vs 42 [12.5%]), leading to treatment discontinuation in 0 vs 6 (1.8%) pts, respectively. Incidences of weight increase TEAEs were balanced across pts categorised as normal, overweight or obsese by baseline body mass index (BMI; Figure). A weight decrease TEAE was reported in 7 pts (2.1%) in the ESK-NS arm vs 0 pts in the QTP-XR arm. Mean (standard deviation [SD]) weight at baseline was 76.4 (16.2) kg (ESK-NS; n=334) vs 79.1 (16.9) kg (QTP-XR; n=336). At Wk32, mean weight was maintained (76.5 [16.3] kg) in ESK-NS treated pts (n=249; mean [SD] change from baseline: 0.1 [4.0] kg) and increased (80.7 [15.6] kg) in QTP-XR treated pts (n=203; mean [SD] change from baseline: 2.5 [5.1] kg).

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Increase in weight was uncommon with ESK-NS; weight increases were more common with QTP-XR and resulted in more treatment discontinuations. Weight increase was independent from baseline BMI.

We thank the patients who participated. Funding: Janssen, medical writing: Costello Medical, UK

None Declared

People with mental disorders frequently report experiences of discrimination within mental health services, which can have significant detrimental effects on individuals’ well-being and recovery. This study aimed to develop and validate a new standardized measure aiming to assess experiences of stigmatization among people with mental disorders within mental health services.

The scale was developed in Italian and tested for ease of use, comprehension, acceptability, relevance of items and response options within focus group session. A cross-sectional validation survey was conducted among mental health service users in Italy. Exploratory factor analysis with Promax oblique rotation, the Kaiser–Meyer–Olkin (KMO) measure of sampling adequacy and the Bartlett’s test of sphericity were used to assess the suitability of the sample for factor analysis. Reliability was assessed as internal consistency using Cronbach’s alpha and as test–retest reliability using weighted kappa and intraclass correlation coefficient (ICC). Precision was examined by Kendall’s tau-b coefficient.

Overall, 240 people with mental disorders participated in the study; 56 also completed the retest evaluation after 2 weeks. The 18 items of the scale converged over a two-factor solution (‘Dignity violation and personhood devaluation’ and ‘Perceived life restrictions and social exclusion’), accounting for 56.4% of the variance (KMO 0.903; Bartlett’s test p < 0.001). Cronbach’s alpha for the total score was 0.934. The scale showed one item with kappa above 0.81, four items between 0.61 and 0.80, ten items between 0.41 and 0.60, two items between 0.21 and 0.40 and only one item below 0.20. ICC was 0.928 (95% CI 0.877–0.958). Kendall’s tau-b ranged from 0.450 to 0.617 (p < 0.001).

The newly developed scale represents a valid and reliable measure for assessing experiences of stigma among patients receiving care within mental health services. The scale has provided initial evidence of being specifically tailored for individuals with psychotic and bipolar disorders. However, the factorial structure of the scale should be replicated through a confirmatory factor analysis on a larger sample of individuals with these conditions.

WHO declared that mental health care should be considered one essential health service to be maintained during the coronavirus disease 2019 (COVID-19) pandemic. This study aims to describe the effect of lockdown and restrictions due to the COVID-19 pandemic in Italy on mental health services’ utilisation, by considering psychiatric diagnoses and type of mental health contacts.

The study was conducted in the Verona catchment area, located in the Veneto region (northeastern Italy). For each patient, mental health contacts were grouped into: (1) outpatient care, (2) social and supportive interventions, (3) rehabilitation interventions, (4) multi-professional assessments, (5) day care. A ‘difference in differences’ approach was used: difference in the number of contacts between 2019 and 2020 on the weeks of lockdown and intermediate restrictions was compared with the same difference in weeks of no or reduced restrictions, and such difference was interpreted as the effect of restrictions. Both a global regression on all contacts and separate regressions for each type of service were performed and Incidence Rate Ratios (IRRs) were calculated.

In 2020, a significant reduction in the number of patients who had mental health contacts was found, both overall and for most of the patients’ characteristics considered (except for people aged 18–24 years for foreign-born population and for those with a diagnosis of schizophrenia. Moreover, in 2020 mental health contacts had a reduction of 57 096 (−33.9%) with respect to 2019; such difference remained significant across the various type of contacts considered, with rehabilitation interventions and day care showing the greatest reduction. Negative Binomial regressions displayed a statistically significant effect of lockdown, but not of intermediate restrictions, in terms of reduction in the number of contacts. The lockdown period was responsible of a 32.7% reduction (IRR 0.673; p-value <0.001) in the overall number of contacts. All type of mental health contacts showed a reduction ascribable to the lockdown, except social and supportive interventions.

Despite the access to community mental health care during the pandemic was overall reduced, the mental health system in the Verona catchment area was able to maintain support for more vulnerable and severely ill patients, by providing continuity of care and day-by-day support through social and supportive interventions.

Care needs represent an essential paradigm in planning residential facility (RF) interventions. However, possible disagreements between users and staff are critical issues in service delivery. The Experience Sampling Method (ESM) tracks experiences in the real world and real time. This study aimed to evaluate the care needs of patients with schizophrenia spectrum disorder (SSD) in RFs and its association with daily activities and mood monitored using the ESM.

As part of the DIAPASON project, 313 residents with SSD were recruited from 99 Italian RFs. Sociodemographic and clinical characteristics were recorded. Care needs, the severity of symptomatology and negative symptoms were assessed. Fifty-six residents were also assessed for 7 consecutive days using the mobile ESM. Descriptive, agreement, predictor and moderator analyses were conducted.

The staff rated a higher number of total and met needs than service users (p < 0.001). Only a slight agreement between users and staff on unmet needs was found in self-care (k = 0.106) and information (k = 0.100) needs, while a moderate agreement was found in accommodation (k = 0.484), food (k = 0.406), childcare (k = 0.530), physical health (k = 0.470), telephone (k = 0.458) and transport (k = 0.425) needs. Older age (−0.15; p < 0.01), longer SSD diagnosis (−0.16; p < 0.01), higher collaboration (−0.16; p < 0.01) and lower symptomatology (−0.16; p < 0.01) decreased the number of unmet needs, while being a female (0.27; p < 0.05) and a shorter length of stay in an RF (0.54; p < 0.001) increased the number of unmet needs. A higher number of unmet needs was associated with a lower amount of time spent in leisure activities or reporting a positive mood: on the contrary, more unmet needs were associated with a greater amount of time spent in religious or non-productive activities. The associations between unmet needs rated by staff and users and momentary mood as assessed using the ESM were not moderated by the severity of symptomatology.

Although care needs are fundamental in planning residential activities aimed at recovery-oriented rehabilitation, RF interventions did not fully meet users' needs, and some disagreements on unmet needs between users and staff were reported. Further efforts are necessary to overcome Italian RF limits in delivering rehabilitative interventions defined by real users' needs to facilitate users' productivity and progress towards personal recovery.

Scientific literature debates on the economic affordability of transcatheter aortic valve implantation (TAVI) in order to give a useful support to decision makers aiming at establishing a reimbursement scheme for TAVI. For this reason, it is important to assess the quality and the generalizability of the existing economic evidences.

The first step was to run a literature search according to a predefined population, intervention, comparator, and outcome on the cost and effectiveness of the TAVI procedure in comparison to medical therapy and traditional surgery. Second, a manual search was carried out on the Web sites of the main HTA agencies. Third, the checklist developed by Augustovski et al. was applied in order to assess the quality and the generalizability of the articles resulting from the selection process.

Overall, 106 articles were obtained. Of these, sixty-five articles were excluded since the title was not consistent with the objective. Further selection took place after abstract and full-text reading. In the end, thirty-one documents were included for the review. According to the checklist, none of the articles was considered generalizable and only one was considered transferable which compares the TAVI procedure with Medical Management in inoperable patients.

Despite the overall quality of the selected studies was considered good, there is still a lack of evidence on whether evidences generated in different contexts can be considered generalizable. Further research on resource consumption and preferences is needed in order to provide decision makers with more robust evidences.

Healthcare workers exposed to coronavirus 2019 (COVID-19) patients could be psychologically distressed. This study aims to assess the magnitude of psychological distress and associated factors among hospital staff during the COVID-19 pandemic in a large tertiary hospital located in north-east Italy.

All healthcare and administrative staff working in the Verona University Hospital (Veneto, Italy) during the COVID-19 pandemic were asked to complete a web-based survey from 21 April to 6 May 2020. Symptoms of post-traumatic distress, anxiety and depression were assessed, respectively, using the Impact of Event Scale (IES-R), the Self-rating Anxiety Scale (SAS) and the Patient Health Questionnaire (PHQ-9). Personal socio-demographic information and job characteristics were also collected, including gender, age, living condition, having pre-existing psychological problems, occupation, length of working experience, hospital unit (ICUs and sub-intensive COVID-19 units vs. non-COVID-19 units). A multivariable logistic regression analysis was performed to identify factors associated with each of the three mental health outcomes.

A total of 2195 healthcare workers (36.9% of the overall hospital staff) participated in the study. Of the participants, 35.7% were nurses, 24.3% other healthcare staff, 16.4% residents, 13.9% physicians and 9.7% administrative staff. Nine per cent of healthcare staff worked in ICUs, 8% in sub-intensive COVID-19 units and 7.6% in other front-line services, while the remaining staff worked in hospital units not directly engaged with COVID-19 patients. Overall, 63.2% of participants reported COVID-related traumatic experiences at work and 53.8% (95% CI 51.0%–56.6%) showed symptoms of post-traumatic distress; moreover, 50.1% (95% CI 47.9%–52.3%) showed symptoms of clinically relevant anxiety and 26.6% (95% CI 24.7%–28.5%) symptoms of at least moderate depression. Multivariable logistic regressions showed that women, nurses, healthcare workers directly engaged with COVID-19 patients and those with pre-existing psychological problems were at increased risk of psychopathological consequences of the pandemic.

The psychological impact of the COVID-19 pandemic on healthcare staff working in a highly burdened geographical of north-east Italy is relevant and to some extent greater than that reported in China. The study provides solid grounds to elaborate and implement interventions pertaining to psychology and occupational health.

1. (1) To understand the capacity building of a short training programme in CBT for early psychosis dedicated to community mental health professionals.

2. (2) To consider the optimal characteristics of a CBT training programme for early psychosis.

3. (3) To reflect on the feasibility of a CBT training programme for early psychosis in the context of Italian Community Mental Health Services.

The quality of mental health services is crucial for the effectiveness and efficiency of mental healthcare systems, symptom reduction, and quality of life improvements in persons with mental illness. In recent years, particularly care coordination (i.e., the integration of care across different providers and treatment settings) has received increased attention and has been put into practice. Thus, we focused on care coordination in this update of a previous European Psychiatric Association (EPA) guidance on the quality of mental health services.

We conducted a systematic meta-review of systematic reviews, meta-analyses, and evidence-based clinical guidelines focusing on care coordination for persons with mental illness in three literature databases.

We identified 23 relevant documents covering the following topics: case management, integrated care, home treatment, crisis intervention services, transition from inpatient to outpatient care and vice versa, integrating general and mental healthcare, technology in care coordination and self-management, quality indicators, and economic evaluation. Based on the available evidence, we developed 15 recommendations for care coordination in European mental healthcare.

Although evidence is limited, some concepts of care coordination seem to improve the effectiveness and efficiency of mental health services and outcomes on patient level. Further evidence is needed to better understand the advantages and disadvantages of different care coordination models.