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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 depress

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. Concl, European Union (EU); Horizon 2020; European Commission (EC); RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence-based psychosocial interventions

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. Conclusi

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 im

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 losrefugiados y solicitantes de asilo son escasos. Objetivos: investigar las trayectorias de los síntomas psi, European Union (EU); Horizon 2020; European Commission (EC); RE-DEFINE: Refugee Emergency DEFining and Implementing Novel Evidence-based psycho-social Interventions

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.

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.

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., European Union (EU); Horizon 2020; European Commission (EC); RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions

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.