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".

Deepening Depression in Women Balancing Work-Life Responsibilities and Caregiving during the COVID-19 Pandemic: Findings from Gender-Specific Face-to-Face Street Interviews Conducted in Italy.

PURPOSE: This study investigated the impact of the COVID-19 pandemic on mental health, quality of life, and family functioning in a sample of the general female population, exploring difficulties encountered in managing family and work responsibilities and burden of care when taking care of a loved one. This study was, moreover, aimed at investigating factors capable of influencing severe depressive symptomatology in the context of socio-demographics, traumatic events, individual vulnerability, and family functioning. METHOD: The sampling method used in this research was non-probability sampling. The survey took place during a Hospital Open Weekend (8-10 October 2021) organized by the National Gender Observatory on Women's Health "Fondazione Onda" on the occasion of the World Mental Health Day. RESULTS: A total of 211 women were interviewed (mean age = 35.6, 53% living alone, more than 15% with financial difficulties, 47% exposed to the 2009 L'Aquila earthquake). More than 50% of the sample reported a higher complexity in managing their lives during the COVID-19 pandemic compared to their previous routine, with no statistically significant differences between working women and non-workers, although the latter obtained higher scores for depressive symptomatology and poorer quality of life. Compared to non-caregivers, female caregivers (22.3%) in charge of the care of loved ones affected by physical (10.9%) or psychiatric disabilities (11.4%) complained of a poorer quality of life, especially in general health perception (p = 0.002), physical function (p = 0.011), role limitations related to physical problems (p = 0.017), bodily pain (p = 0.015), mental health (p = 0.004), and social functioning (p = 0.007). Women caring for people affected by mental disorders seemed to experience a more significant worsening in vitality (p = 0.003) and social functioning (p = 0.005). Approximately 20% of the total sample reported severe depressive symptomatology. Previous access to mental health services (O.R. 10.923; p = 0.000), a low level of education (O.R. 5.410; p = 0.021), and difficulties in management of everyday lives during the COVID-19 pandemic (O.R. 3.598; p = 0.045) were found to be the main variables predictive of severe depressive psychopathology. Old age, good problem-solving skills, and ability to pursue personal goals were identified as protective factors. CONCLUSIONS: The COVID-19 pandemic underlined the need for support amongst emotionally vulnerable women with pre-existing mental health conditions, partly reflecting the cumulative effects of traumas.

Twelve-month outcomes in overweight/obese users with mental disorders following a multi-element treatment including diet, physical activity, and positive thinking: The real-world "An Apple a Day" controlled trial.

The present study aimed to evaluate the 12-month effectiveness of a real-world weight loss transdiagnostic intervention in overweight/obese participants affected by mental disorders under psychopharmacological treatment. We conducted a real-world, controlled, pragmatic outpatient trial. We allocated 58 overweight/obese adults under psychopharmacological treatment from a mental health outpatient unit and 48 overweight/obese adults from a cardiovascular prevention outpatient unit, and assigned them to an intervention or treatment usual as condition (TAU) enriched by life-style advice. Participants in both intervention groups took part in a diet programme (the modified OMNIHeart dietary protocol) and monitoring of regular aerobic activity. A brief group programme ("An Apple a Day" Metacognitive Training, Apple-MCT) was added in the intervention group of participants affected by mental disorders. The primary outcome was weight loss. Secondary outcomes included anthropometric, clinical, and metabolic variables. Psychopathology and health-related quality of life were also evaluated in the psychiatric sample. At 12 months, both intervention groups showed a more marked mean decrease in weight (6.7 kg, SD: 3.57) than the TAU group (0.32 kg, SD: 1.96), and a statistically significant improvement in metabolic variables compared with the control groups. Furthermore, the participants affected by mental disorders included in the intervention group reported improved health-related quality of life. Our findings suggest the need to implement integrated interventions based on a dietary protocol, physical activity, and modification of cognitive style in overweight/obese users with mental disorders.

Predictors of academic performance during the covid-19 outbreak: impact of distance education on mental health, social cognition and memory abilities in an Italian university student sample.

BACKGROUND: This study aimed to investigate the impact of distance education (DE) on mental health, social cognition, and memory abilities in a sample of university students during the national COVID-19 lockdown in Italy and to identify the predictors of academic performance. METHODS: Two hundred and three students (76.4% women, mean age 24.3, SD ± 4.9) responded to an anonymous online cross-sectional survey between July 15 and September 30, 2020, on DE experience and cognitive and social-cognitive variables. A short version of the Beck Depression Inventory-II, ten images from the Eyes Task, and five memory vignette stimuli were included in the survey. Descriptive, one-way ANOVA, correlation, and logistic regression analyses were conducted. RESULTS: Half of the student sample reported significant impairment in concentration and learning abilities during DE. Regarding psychological health, 19.7%, 27.1%, and 23.6% of the sample reported mild, moderate, and severe depressive symptoms, respectively. Correlation analyses showed a statistically significant negative association between depression and the overall subjective evaluation of DE (r = - 0.359; p < 0.000). Changes in one's study context and habits, i.e., studying alone at one's parents' home instead of studying with colleagues or alone in a university "social place" (e.g., the university library), seemed to increase the likelihood of poor academic performance by almost 3 times (O.R. 3.918; p = 0.032). This predictor was no longer statistically significant in the subsequent step when the individual impairment predictors were entered. Learning concentration impairment during DE (O.R. 8.350; p = 0.014), anxiety about COVID-19 contagion for oneself or others (O.R. 3.363; p = 0.022), female gender (O.R. 3.141; p = 0.045), and depressive symptomatology (O.R. 1.093; p = 0.047) were ultimately determined to be the strongest predictors of poor academic performance, whereas the appreciation of DE represented a protective variable (O.R. 0.610; p < 0.000). CONCLUSIONS: The study showed a negative impact of DE on the mental health of students presenting depressive symptoms and impairment in concentration and learning, the latter identified as the strongest predictors of poor academic performances. The study confirms the emerging need to monitor the impact of DE, which occurred during the 2019/2020 academic year and will continue in the coming months, to refine educational offerings and meet students' psychological needs by implementing psychological interventions based on the modifiable variables that seem to compromise students' psychological well-being and academic outcomes.

"Hang in There!": Mental Health in a Sample of the Italian Civil Protection Volunteers during the COVID-19 Health Emergency.

Few studies have been conducted on civil volunteers and their emotional conditions concerning the current COVID-19 pandemic. The present study aimed to evaluate the impact of the COVID-19 emergency on the mental health (general well-being, depression level, and post-traumatic distress), coping strategies, and training needs in an Italian sample of 331 Civil Protection volunteers of the L'Aquila province, during the first nationwide "lockdown" (8 March-3 June 2020). The rate of respondents to the online survey was limited (11.5%), presumably because displaying distress would be considered a sign of "weakness", making volunteers unable to do their jobs. More than 90% of the volunteers showed good mental health conditions and a wide utilization of positive coping strategies, with the less experienced displaying better emotional conditions compared to colleagues with 10 or more years of experience. The type of emergency, the relatively few cases of contagion and mortality in the territory compared to the rest of Italy, and the sense of helping the community, together with the awareness of their group identity, could have contributed to the reported well-being. These results may help to identify the needs of volunteers related to this new "urban" emergency to improve both their technical and emotional skills.

Heart and Head: Profiles and Predictors of Self-Assessed Cognitive and Affective Empathy in a Sample of Medical and Health Professional Students.

For medical and health professions, students learning to respond to others' distress with well-regulated empathy is an important developmental skill linked to positive health outcomes and professionalism. Our study aimed to investigate the sociodemographic, psychological, and psychosocial differences between medical (MS) and health professional (HPS) students and their empathic abilities, since both populations share common stressors, namely, dealing with suffering people. Additionally, we were interested in assessing the psychological and psychosocial predictors of empathy of MS compared to HPS. One hundred thirty MS and 86 HPS were administered the Patient Health Questionnaire-9, Interpersonal Reactivity Index, Integrative Hope Scale, and UCLA Loneliness Scale. The two groups showed differences in their contextual characteristics, with the HPS group having larger families, lower parents' education levels, and lower family income compared to the MS group. In both groups, ~15% of students reported previous contact for psychological problems. A higher proportion of HPS (23.3%) reported depressive symptoms than MS (10%), and female HPS reported more intense feelings of loneliness than other subgroups of students. No differences were found between the two groups in self-assessed cognitive and affective empathy. In both groups, women showed greater affective scores than men and, at the same time, seemed to be particularly prone to personal distress. The cognitive empathic dimension of "perspective taking" was predicted by young age (OR, 612; 95% CI, 1.395-15.242) and the overall socioeconomic status (OR, 3.175; 95% CI, 1.154-8.734) of the HPS. Self-assessed affective competence was predicted by female gender (OR, 3.112; 95% CI, 1.328-7.288), depressive symptomatology (OR, 2.777; 95% CI, 1.004-7.681), higher mother's level of education (OR, 2.764; 95% CI, 1.147-6.659), and feeling of hope related to social relationships (OR, 1.367; 95% CI, 1.152-1.622). Risk factors for poor self-assessed affective emphatic skills were previous contact for psychological problems (OR, 3.263; 95% CI, 1.238-8.601) and feelings of loneliness (OR, 1.18; 95% CI, 1.09-1.276). Our findings emphasize the need to test psychosocial models to better understand empathic skills.

#Everything Will Be Fine. Duration of Home Confinement and "All-or-Nothing" Cognitive Thinking Style as Predictors of Traumatic Distress in Young University Students on a Digital Platform During the COVID-19 Italian Lockdown.

On March 10, 2020, Italy announced its lockdown caused by the novel coronavirus (COVID-19) pandemic, and home confinement exposed individuals to a stressful situation of unknown duration. Our study aimed to analyze the emotional and cognitive experiences and the psychopathological symptoms of young Italian University students seeking help from our University student Counseling and Consultation Service during the COVID-19 lockdown. Also, our study aimed to identify the predictors of traumatic psychological distress, investigating variables that could influence the students' well-being, related to their socio-demographic and clinical condition, to the "exposition" to the social distancing, and related to their cognitive thinking style. One-hundred and three University students were included in our study. The traumatic impact was assessed by the Impact of Event Scale-Revised (IES-R). A digital platform was used in our study, focused on narrative dimensions analyses. Our results showed that 21.4% of our help-seeking students experienced lockdown as a traumatic experience. The main stressful factors reported by students were: adjustment to the new academic activities (23.3 %), lack of autonomy (19.4%), and conflicts with family members (6.8%). The three main areas impaired were: changes in the sleeping pattern (68%), difficulty in concentration (67%), and loss of energy (58.6%). Furthermore, 36% of our student sample reported being suffering from anxiety symptoms, whereas 26% showed depressive symptomatology. Students having previous psychological and psychiatric contacts with mental health services (23%) showed a more severe traumatic and depressive symptomatology. The problematic thinking style "all or nothing" was predominantly associated with psychological distress, anxiety, depression, and posttraumatic symptoms. "Everything Will Be Fine" could be identified by the "optimistic style" (27.2%), inversely correlated with the psychopathological measures and concentration problems. The results of the logistic regression analysis indicated that the length of home confinement (second month) seemed to increase by over 3 times the likelihood of experience posttraumatic symptomatology, and a thinking style "all or nothing" was the final strongest predictor increasing the risk by over 5 times. The implementation of psychological interventions to improve the mental health of vulnerable young subgroups to contain the structuring of psychopathological profiles represent a fundamental challenge.

Trail Making Test Induces Prefrontal Cortex Activation as Revealed by a cw Wearable-Wireless fNIRS/DOT Imager.

The recent availability of low-cost wearable continuous wave (cw) fNIRS/DOT devices is supposed to revolutionize cortical human brain mapping in the real-life. Ecological paper-pencil tests, as the Trail Making Test (TMT), are commonly used in neuropsychological clinics but its neural substrates are not completely understood. The aim of this study was to map, using a new cw wearable fNIRS/DOT imager (NIRSIT), the prefrontal cortex (PFC) hemodynamic response in healthy subjects while performing the TMT. The ANOVA analysis, performed on the 60 region-DOT data, shows a significant task-related activation of the PFC. These preliminary results support the validity of this wearable technology to provide online high-density PFC activation maps.

Assessment of cerebellar vermis biometry at 18-32 weeks of gestation by three-dimensional ultrasound examination.

OBJECTIVE: The purpose of this study was to construct reference limits for cerebellar vermis (CV) dimensions measured on images reconstructed from three-dimensional (3D) ultrasonography and to evaluate these measurements reproducibility. METHODS: 3D ultrasound volumes were acquired transabdominally from an axial view of the fetal head in 342 fetuses cross-sectionally studied between 18 to 32 weeks of gestation. Offline analysis of fetal brain midsagittal plane was used to evaluate length and area of CV. The agreement between two-dimensional (2D) and 3D measurements as well as the interobserver variability in 3D measurements were assessed by interclass correlation coefficients (ICC). RESULTS: Adequate visualization of the midsagittal plane was obtained in 96.7% of the fetuses. CV length (r = 0.89, p < 0.0001) and CV area (r = 0.93, p < 0.0001) showed a significant linear growth with gestation. A good agreement was found between measurements from either 2D or 3D ultrasound views (CV length ICC 0.943, CV area ICC 0.940) as well as between measured obtained by different observers (CV length ICC 0.965, CV area ICC 0.905). CONCLUSIONS: Measurements of the CV can be obtained from the midsagittal plane of fetal brain reconstructed from 3D volumes acquired transabdominally. The constructed nomograms may facilitate the diagnosis of cerebellar abnormalities.