Larger putamen in individuals at risk and with manifest bipolar disorder.

BACKGROUND: Individuals at risk for bipolar disorder (BD) have a wide range of genetic and non-genetic risk factors, like a positive family history of BD or (sub)threshold affective symptoms. Yet, it is unclear whether these individuals at risk and those diagnosed with BD share similar gray matter brain alterations. METHODS: In 410 male and female participants aged 17-35 years, we compared gray matter volume (3T MRI) between individuals at risk for BD (as assessed using the EPIbipolar scale; n = 208), patients with a DSM-IV-TR diagnosis of BD (n = 87), and healthy controls (n = 115) using voxel-based morphometry in SPM12/CAT12. We applied conjunction analyses to identify similarities in gray matter volume alterations in individuals at risk and BD patients, relative to healthy controls. We also performed exploratory whole-brain analyses to identify differences in gray matter volume among groups. ComBat was used to harmonize imaging data from seven sites. RESULTS: Both individuals at risk and BD patients showed larger volumes in the right putamen than healthy controls. Furthermore, individuals at risk had smaller volumes in the right inferior occipital gyrus, and BD patients had larger volumes in the left precuneus, compared to healthy controls. These findings were independent of course of illness (number of lifetime manic and depressive episodes, number of hospitalizations), comorbid diagnoses (major depressive disorder, attention-deficit hyperactivity disorder, anxiety disorder, eating disorder), familial risk, current disease severity (global functioning, remission status), and current medication intake. CONCLUSIONS: Our findings indicate that alterations in the right putamen might constitute a vulnerability marker for BD.

[Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders]. / Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen.

Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders Abstract: As a vulnerable group, minors require special protection in studies. For this reason, researchers are often reluctant to initiate studies, and ethics committees are reluctant to authorize such studies. This often excludes minors from participating in clinical studies. This exclusion can lead to researchers and clinicians receiving only incomplete data or having to rely on adult-based findings in the treatment of minors. Using the example of the study "Computer-Assisted Risk Evaluation in the Early Detection of Psychotic Disorders" (CARE), which was conducted as an 'other clinical investigation' according to the Medical Device Regulation, we present a line of argumentation for the inclusion of minors which weighs the ethical principles of nonmaleficence (especially regarding possible stigmatization), beneficence, autonomy, and fairness. We show the necessity of including minors based on the development-specific differences in diagnostics and early intervention. Further, we present specific protective measures. This argumentation can also be transferred to other disorders with the onset in childhood and adolescence and thus help to avoid excluding minors from appropriate evidence-based care because of insufficient studies.

Staging 2.0: refining transdiagnostic clinical staging frameworks to enhance reliability and utility for youth mental health.

Globally, 75% of depressive, bipolar, and psychotic disorders emerge by age 25 years. However, these disorders are often preceded by non-specific symptoms or attenuated clinical syndromes. Difficulties in determining optimal treatment interventions for these emerging mental disorders, and uncertainties about accounting for co-occurring psychopathology and illness trajectories, have led many youth mental health services to adopt transdiagnostic clinical staging frameworks. In this Health Policy paper, an international working group highlights ongoing challenges in applying transdiagnostic staging frameworks in clinical research and practice, and proposes refinements to the transdiagnostic model to enhance its reliability, consistent recording, and clinical utility. We introduce the concept of within-stage heterogeneity and describe the advantages of defining stage in terms of clinical psychopathology and stage modifiers. Using examples from medicine, we discuss the utility of categorising stage modifiers into factors associated with progression (ie, potential predictors of stage transition) and extension (ie, factors associated with the current presentation that add complexity to treatment selection). Lastly, we suggest how it is possible to revise the currently used transdiagnostic staging approach to incorporate these key concepts, and how the revised framework could be applied in clinical and research practice.

soulspace: Integrated youth mental health care in Berlin, Germany-An introduction to the program and a description of its users.

AIM: A substantial gap between young people's need for mental health care services and their actual access to such services led worldwide organizations (e.g., the WHO) to recommend the implementation of early intervention programs and youth mental health services. Some countries around the world have established structures to meet this recommendation. In this paper, we describe soulspace as the first integrated youth mental health service for young people aged between 15 and 35 years in Berlin, Germany. METHODS: We introduce soulspace as easily accessible mental health care for young people, and we characterize soulspace along the lines of the internationally established eight key principles of integrated youth mental health services (Killackey, et al., 2020, World Economic Forum). Soulspace is a cooperation between clinical outpatient units of psychiatric clinics for adolescents and young adults as well as a community-based counselling service. It provides initial contact, counselling, diagnostics, and treatment. RESULTS: Our analyses of the pathways to soulspace and the characteristics of the soulspace users suggest that the low threshold is a facilitator to help finding for young people in comparison to more conventional early intervention models. That is, having transferred the early intervention center in a youth-facing counselling service as was done in soulspace seems to have reduced the threshold to seek help for families and for young people in need for support. CONCLUSIONS: In summary, with soulspace, an easily accessible mental health care service was established that integrates counselling and specialized psychiatric treatment if needed.

Leaving the stigma to the patients? Frequency of crisis experiences among mental health professionals in Berlin and Brandenburg and how they cope with it.

BACKGROUND: Although mental health professionals' mental health problems are gaining increased attention, there is little systematic research on this topic. AIMS: This study investigated the frequency of crisis experiences among mental health professionals and examined how they approach these experiences in terms of their personal and social identities. METHODS: An online survey was conducted among mental health professionals in 18 psychiatric hospital departments in the German federal states of Berlin and Brandenburg (N = 215), containing questions about personal crisis experiences, help sought, service use, meaningfulness of lived experiences, causal beliefs of mental illness and psychotherapeutic orientation. Social identification was assessed via semantic differential scales derived from preliminary interview studies. To investigate relationships between the variables, explorative correlation analyses were calculated. RESULTS: Results showed a high frequency rate of crisis experiences, substantial rates of suicidal ideation and incapacity to work and high service use. Most participants regarded their experiences as meaningful for their personal identity. Meaningfulness was positively related to a psychosocial causation model of mental illness, to psychodynamic psychotherapeutic orientation and to a high degree of disidentification with users and crisis experienced colleagues. CONCLUSION: The (paradoxical) disintegration of personal and social identity of may be understood as a strategy to avoid stigmatization. A more challenging coping style among professionals is discussed.

[Inpatient Equivalent Home Treatment (IEHT) compared to inpatient psychiatric treatment: 12-month follow-up results of a retrospectively matched cohort study using propensity score]. / Stationsäquivalente Behandlung (StäB) im Vergleich mit vollstationärer Behandlung: 12-Monats-Follow-up Ergebnisse einer mittels Propensity-Score gematchten retrospektiven Kohortenstudie.

AIM OF THE STUDY: Comparison of psychiatric services use in the 12-month follow-up period between Inpatient Equivalent Home Treatment (IEHT) and inpatient psychiatric treatment. METHODS: In a retrospective 12-month follow-up study, 223 patients from the Inpatient Equivalent Home Treatment (IEHT) intervention group (IG) were compared to a matched inpatient control group (CG) on their utilization of psychiatric services. RESULTS: The inpatient readmission rate in the IG was significantly 11% lower than in the CG. The number of treatment days in the IG was significantly lower than in the CG. In the IG, psychiatric services at the outpatient clinic were used significantly more often for the first time than in the CG. CONCLUSION: The present study suggests that IEHT is superior to inpatient treatment in terms of the risk of inpatient readmission and the duration of inpatient treatment days. An outpatient services use effect following IEHT is observed.

Prediction of estimated risk for bipolar disorder using machine learning and structural MRI features.

BACKGROUND: Individuals with bipolar disorder are commonly correctly diagnosed a decade after symptom onset. Machine learning techniques may aid in early recognition and reduce the disease burden. As both individuals at risk and those with a manifest disease display structural brain markers, structural magnetic resonance imaging may provide relevant classification features. METHODS: Following a pre-registered protocol, we trained linear support vector machine (SVM) to classify individuals according to their estimated risk for bipolar disorder using regional cortical thickness of help-seeking individuals from seven study sites (N = 276). We estimated the risk using three state-of-the-art assessment instruments (BPSS-P, BARS, EPIbipolar). RESULTS: For BPSS-P, SVM achieved a fair performance of Cohen's κ of 0.235 (95% CI 0.11-0.361) and a balanced accuracy of 63.1% (95% CI 55.9-70.3) in the 10-fold cross-validation. In the leave-one-site-out cross-validation, the model performed with a Cohen's κ of 0.128 (95% CI -0.069 to 0.325) and a balanced accuracy of 56.2% (95% CI 44.6-67.8). BARS and EPIbipolar could not be predicted. In post hoc analyses, regional surface area, subcortical volumes as well as hyperparameter optimization did not improve the performance. CONCLUSIONS: Individuals at risk for bipolar disorder, as assessed by BPSS-P, display brain structural alterations that can be detected using machine learning. The achieved performance is comparable to previous studies which attempted to classify patients with manifest disease and healthy controls. Unlike previous studies of bipolar risk, our multicenter design permitted a leave-one-site-out cross-validation. Whole-brain cortical thickness seems to be superior to other structural brain features.

Young people at risk for developing bipolar disorder: Two-year findings from the multicenter prospective, naturalistic Early-BipoLife study.

Early identification and intervention of individuals with an increased risk for bipolar disorder (BD) may improve the course of illness and prevent long­term consequences. Early-BipoLife, a multicenter, prospective, naturalistic study, examined risk factors of BD beyond family history in participants aged 15-35 years. At baseline, positively screened help-seeking participants (screenBD at-risk) were recruited at Early Detection Centers and in- and outpatient depression and attention-deficit/hyperactivity disorder (ADHD) settings, references (Ref) drawn from a representative cohort. Participants reported sociodemographics and medical history and were repeatedly examined regarding psychopathology and the course of risk factors. N = 1,083 screenBD at-risk and n = 172 Ref were eligible for baseline assessment. Within the first two years, n = 31 screenBD at-risk (2.9 %) and none of Ref developed a manifest BD. The cumulative transition risk was 0.0028 at the end of multistep assessment, 0.0169 at 12 and 0.0317 at 24 months (p = 0.021). The transition rate with a BD family history was 6.0 %, 4.7 % in the Early Phase Inventory for bipolar disorders (EPIbipolar), 6.6 % in the Bipolar Prodrome Interview and Symptom Scale-Prospective (BPSS-FP) and 3.2 % with extended Bipolar At-Risk - BARS criteria). In comparison to help-seeking young patients from psychosis detection services, transition rates in screenBD at-risk participants were lower. The findings of Early-BipoLife underscore the importance of considering risk factors beyond family history in order to improved early detection and interventions to prevent/ameliorate related impairment in the course of BD. Large long-term cohort studies are crucial to understand the developmental pathways and long-term course of BD, especially in people at- risk.

Implementation of guidelines on prevention of coercion and violence (PreVCo) in psychiatry: a multicentre randomised controlled trial.

Background: Interventions to prevent the use of coercion in psychiatric hospitals have been summarized in the 2018 German Association for Psychiatry, Psychotherapy, and Psychosomatic's comprehensive guidelines. Twelve recommendations for implementation of these guideline on psychiatric wards have been deducted and their feasibility has been tested in a pilot study, using external implementation consultants as facilitators. The objective of the PreVCo study was to test their effect in a randomised clinical trial. Methods: Fifty-four psychiatric wards in Germany treating voluntary and involuntary patients were randomly allocated to either an intervention or to a waiting list condition. The intervention consisted of the implementation of three out of 12 suggested recommendations as selected by the ward teams, supported by external study workers. As the primary outcome measure, the number of coercive measures used per bed and month in the final 3 months of the intervention period was determined. Secondary outcomes were the cumulative duration of coercive measures used per bed and months and assaults per bed and month. Achieved guideline adherence was measured by a fidelity scale developed for this purpose during a pilot study for the PreVCo Rating Tool. After a 3-month baseline collection period under routine conditions, randomisation was done after matching wards pairwise according to frequency of coercive measures used and scores on the PreVCo Rating Tool at baseline. The duration of the intervention period was 12 months; control wards received only an initial workshop presentation of the study and completed their PreVCo ratings. We used the Wilcoxon signed rank test and the paired t-test and conducted sensitivity analyses for different periods of observation. Findings: Neither the number of coercive measures used per month and bed nor their cumulative duration nor the number of assaults per bed and months differed significantly between the 27 intervention wards and the 27 control wards in the final 3 months of the intervention period. The median number of coercive measures used decreased by 45% (median 0.96 (IQR 1.34)-0.53 (IQR 0.59) from baseline until the end of the intervention period on the intervention wards and by 28% (median 0.98 (IQR 1.71)-0.71 (IQR 1.08) on waiting list wards. The PreVCo Rating Tool showed a significant improvement in intervention wards compared to control wards, indicating a successful implementation. Interpretation: The study demonstrated that guideline adherence could be significantly improved by the intervention. However, there was no evidence for an effect on the frequency or duration of coercive measures used. Spill-over effects and the impact of the COVID-19 pandemic on in-patient care might have limited the effect of the intervention. Further research from robust randomised controlled trials are necessary to identify effective interventions to reduce the use of coercion in psychiatric hospitals. Funding: The study was funded by the German Innovationsfonds beim Gemeinsamen Bundesausschuss (project no. 01VSF19037). The funder had no role in study design or data collection.

[Does Inpatient Equivalent Home Treatment lead to higher satisfaction? Results on satisfaction of persons involved in treatment within the Multi-center AKtiV Study]. / Stößt die Behandlung zu Hause auf größere Zufriedenheit? Ergebnisse zur Zufriedenheit der an der Behandlung beteiligten Personengruppen im Rahmen der multizentrischen AKtiV-Studie.

This part of the AKtiV Study focuses on treatment satisfaction of patients and their relatives within Inpatient Equivalent Home Treatment (IEHT) and regular treatment. Stress of relatives and job satisfaction and workload of employees in IEHT is also considered. Relevant Parameters were collected via established as well as newly adapted questionnaires at the end of treatment. Patients and relatives in IEHT are significantly more satisfied. The stress experienced by relatives is reduced in both forms of treatment. Employees in IEHT are generally very satisfied, although there is no correlation with the satisfaction of relatives and patients. Known limitations of satisfaction surveys must be taken into account. In general these results encourage the expansion and continuous development of this new form of treatment in Germany.

Bipolar At-Risk Criteria and Risk of Bipolar Disorder Over 10 or More Years.

Importance: Predicting the onset of bipolar disorder (BD) could facilitate preventive treatments. Among risk measures, bipolar at-risk (BAR) criteria have shown promise in predicting onset of bipolar disorder in the first year in clinical cohorts; however, it is not known whether BAR criteria are associated with the onset of BD in the longer term. Objective: To assess the association of BAR criteria with onset of BD over 10 to 13 years follow-up. Design, Setting, and Participants: This prospective cohort study, completed between May 1, 2020, and November 7, 2022, included consenting people seeking help for nonpsychotic major mental health difficulties, including mood, personality, and substance use disorders, who were originally recruited at ages 15 to 25 years from a tertiary youth mental health setting in metropolitan Melbourne, Victoria, Australia, from May 1, 2008, to September 30, 2010. Exposure: Meeting BAR criteria at baseline. Criteria included subthreshold mania, cyclothymic features, subthreshold depression, and family history of BD. A matched clinical comparison group was recruited from the same help-seeking population. Main Outcomes and Measures: The primary outcome was expert consensus diagnosis of BD I or II based on the Mini International Neuropsychiatric Interview, self-reported information collected through online assessments, and linked data on mental health service utilization in Victoria over 10 to 13 years of follow-up. Results: Among 69 eligible participants, follow-up data were available for 60 (88.2%). The mean (SD) age at the end of follow-up was 32.9 (2.8) years, and 49 (81.7%) were women. A total of 28 participants met BAR criteria, and 32 were in the comparison group. In the BAR group, 8 patients (28.6%) developed BD over a mean (SD) of 11.1 (0.7) years of follow-up, and no patients in the comparison group developed BD. The risk of developing BD was higher in the BAR group than in the non-BAR group (χ21 = 70.0; P < .001). The proportions of transitions to BD were equal in the first and second halves of the follow-up period. Conclusions and relevance: In this cohort study of participants seeking care for mental health difficulties, patients meeting the BAR criteria were significantly more likely to transition to BD over a decade after ascertainment compared with patients not meeting the BAR criteria. The findings suggest that those meeting BAR criteria may benefit from longer-term monitoring and support. Evaluation of predictive properties in longer-term studies using a risk measure will help with implementation of BAR criteria in clinical settings.

Association between cannabis use and symptom dimensions in schizophrenia spectrum disorders: an individual participant data meta-analysis on 3053 individuals.

Background: The association between cannabis use and positive symptoms in schizophrenia spectrum disorders is well documented, especially via meta-analyses. Yet, findings are inconsistent regarding negative symptoms, while other dimensions such as disorganization, depression, and excitement, have not been investigated. In addition, meta-analyses use aggregated data discarding important confounding variables which is a source of bias. Methods: PubMed, ScienceDirect and PsycINFO were used to search for publications from inception to September 27, 2022. We contacted the authors of relevant studies to extract raw datasets and perform an Individual Participant Data meta-analysis (IPDMA). Inclusion criteria were: psychopathology of individuals with schizophrenia spectrum disorders assessed by the Positive and Negative Syndrome Scale (PANSS); cannabis-users had to either have a diagnosis of cannabis use disorder or use cannabis at least twice a week. The main outcomes were the PANSS subscores extracted via the 3-factor (positive, negative and general) and 5-factor (positive, negative, disorganization, depression, excitement) structures. Preregistration is accessible via Prospero: ID CRD42022329172. Findings: Among the 1149 identified studies, 65 were eligible and 21 datasets were shared, totaling 3677 IPD and 3053 complete cases. The adjusted multivariate analysis revealed that relative to non-use, cannabis use was associated with higher severity of positive dimension (3-factor: Adjusted Mean Difference, aMD = 0.34, 95% Confidence Interval, CI = [0.03; 0.66]; 5-factor: aMD = 0.38, 95% CI = [0.08; 0.63]), lower severity of negative dimension (3-factor: aMD = -0.49, 95% CI [-0.90; -0.09]; 5-factor: aMD = -0.50, 95% CI = [-0.91; -0.08]), higher severity of excitement dimension (aMD = 0.16, 95% CI = [0.03; 0.28]). No association was found between cannabis use and disorganization (aMD = -0.13, 95% CI = [-0.42; 0.17]) or depression (aMD = -0.14, 95% CI = [-0.34; 0.06]). Interpretation: No causal relationship can be inferred from the current results. The findings could be in favor of both a detrimental and beneficial effect of cannabis on positive and negative symptoms, respectively. Longitudinal designs are needed to understand the role of cannabis is this association. The reported effect sizes are small and CIs are wide, the interpretation of findings should be taken with caution. Funding: This research did not receive any specific grant or funding. Primary financial support for authors was provided by Le Vinatier Psychiatric Hospital.

[IEHT or inpatient treatment? - First results of the multicenter AKtiV study on inpatient-equivalent home treatment regarding the study population and index treatment]. / StäB oder Station? ­ Erste Ergebnisse zur Studienpopulation und zur Behandlung im Rahmen der multizentrischen AKtiV-Studie zur stationsäquivalenten Behandlung.

AIM: The quasi-experimental AKtiV study investigates the effects inpatient-equivalent home treatment (IEHT). This paper describes the study population based on demographic and clinical parameters at baseline and compares the index treatment. METHODS: Over a period of 12 months 200 IEHT users were included in the intervention group (IG) and 200 inpatients were included in the control group (CG). The comparability of the two groups was ensured by propensity score matching (PSM). RESULTS: In addition to the PSM variables, IG and CG did not differ significantly from each other variables at study inclusion. The duration of the index treatment was significantly longer in the IG (M=37.2 days) compared to the CG (M=27.9 days; p<0.001). CONCLUSION: The similarity of the two groups enables comparisons over 12 months, investigating IEHT effects on long-term outcomes.

Premature termination, satisfaction with care, and shared decision-making during home treatment compared to inpatient treatment: A quasi-experimental trial.

BACKGROUND: Inpatient equivalent home treatment (IEHT), implemented in Germany since 2018, is a specific form of home treatment. Between 2021 and 2022, IEHT was compared to inpatient psychiatric treatment in a 12-months follow-up quasi-experimental study with two propensity score matched cohorts in 10 psychiatric centers in Germany. This article reports results on the treatment during the acute episode and focuses on involvement in decision-making, patient satisfaction, and drop-out rates. METHODS: A total of 200 service users receiving IEHT were compared with 200 matched statistical "twins" in standard inpatient treatment. Premature termination of treatment as well as reasons for this was assessed using routine data and a questionnaire. In addition, we measured patient satisfaction with care with a specific scale. For the evaluation of patient involvement in treatment decisions, we used the 9-item Shared Decision Making Questionnaire (SDM-Q-9). RESULTS: Patients were comparable in both groups with regard to sociodemographic and clinical characteristics. Mean length-of-stay was 37 days for IEHT and 28 days for inpatient treatment. In both groups, a similar proportion of participants stopped treatment prematurely. At the end of the acute episode, patient involvement in decision-making (SDM-Q-9) as well as treatment satisfaction scores were significantly higher for IEHT patients compared to inpatients. CONCLUSIONS: Compared to inpatient care, IEHT treatment for acute psychiatric episodes was associated with higher treatment satisfaction and more involvement in clinical decisions.

Machine Learning Prediction of Estimated Risk for Bipolar Disorders Using Hippocampal Subfield and Amygdala Nuclei Volumes.

The pathophysiology of bipolar disorder (BD) remains mostly unclear. Yet, a valid biomarker is necessary to improve upon the early detection of this serious disorder. Patients with manifest BD display reduced volumes of the hippocampal subfields and amygdala nuclei. In this pre-registered analysis, we used structural MRI (n = 271, 7 sites) to compare volumes of hippocampus, amygdala and their subfields/nuclei between help-seeking subjects divided into risk groups for BD as estimated by BPSS-P, BARS and EPIbipolar. We performed between-group comparisons using linear mixed effects models for all three risk assessment tools. Additionally, we aimed to differentiate the risk groups using a linear support vector machine. We found no significant volume differences between the risk groups for all limbic structures during the main analysis. However, the SVM could still classify subjects at risk according to BPSS-P criteria with a balanced accuracy of 66.90% (95% CI 59.2-74.6) for 10-fold cross-validation and 61.9% (95% CI 52.0-71.9) for leave-one-site-out. Structural alterations of the hippocampus and amygdala may not be as pronounced in young people at risk; nonetheless, machine learning can predict the estimated risk for BD above chance. This suggests that neural changes may not merely be a consequence of BD and may have prognostic clinical value.

Feasibility of six-month outpatient cognitive remediation in schizophrenia: Experience from the randomized controlled integrated social cognition and social skills therapy study.

Patients with schizophrenia often have cognitive impairments that contribute to diminished psychosocial functioning. Cognitive remediation therapy (CRT) has proven efficacy and is recommended by evidence-based treatment guidelines. Important moderators of efficacy include integration of CRT into a psychiatric rehabilitation concept and patient attendance at a sufficient number of therapy sessions. These conditions can probably best be met in an outpatient setting; however, outpatient treatment is prone to higher rates of treatment discontinuation and outpatient settings are not as well protected as inpatient ones and less closely supervised.The present study investigated the feasibility of outpatient CRT in schizophrenia over a six-month period. Adherence to scheduled sessions and safety parameters were assessed in 177 patients with schizophrenia randomly assigned to one of two matched CRT programs.Results showed that 58.8 % of participants completed the CRT (>80 % of scheduled sessions) and 72.9 % completed at least half the sessions. Predictor analysis revealed a high verbal intelligence quotient as favorable for good adherence, but this factor had only low general predictive power. During the six-month treatment phase, serious adverse events occurred in 15.8 % (28/177) of the patients, which is a comparable rate to that reported in the literature.Our findings support the feasibility of six-month outpatient CRT in schizophrenia in terms of adherence to scheduled sessions and safety. Trial registration number: NCT02678858, DRKS00010033.

Implementation of guidelines on prevention of coercion and violence: baseline data of the randomized controlled PreVCo study.

Introduction: The PreVCo study examines whether a structured, operationalized implementation of guidelines to prevent coercion actually leads to fewer coercive measures on psychiatric wards. It is known from the literature that rates of coercive measures differ greatly between hospitals within a country. Studies on that topic also showed large Hawthorne effects. Therefore, it is important to collect valid baseline data for the comparison of similar wards and controlling for observer effects. Methods: Fifty five psychiatric wards in Germany treating voluntary and involuntary patients were randomly allocated to an intervention or a waiting list condition in matched pairs. As part of the randomized controlled trial, they completed a baseline survey. We collected data on admissions, occupied beds, involuntarily admitted cases, main diagnoses, the number and duration of coercive measures, assaults and staffing levels. We applied the PreVCo Rating Tool for each ward. The PreVCo Rating Tool is a fidelity rating, measuring the degree of implementation of 12 guideline-linked recommendations on Likert scales with a range of 0-135 points covering the main elements of the guidelines. Aggregated data on the ward level is provided, with no patient data provided. We performed a Wilcoxon signed-rank-test to compare intervention group and waiting list control group at baseline and to assess the success of randomization. Results: The participating wards had an average of 19.9% involuntarily admitted cases and a median 19 coercive measures per month (1 coercive measure per occupied bed, 0.5 per admission). The intervention group and waiting list group were not significantly different in these measurements. There were 6.0 assaults per month on average (0.3 assaults per occupied bed and 0.1 per admission). The PreVCo Rating Tool for guideline fidelity varied between 28 and 106 points. The percentage of involuntarily admitted cases showed a correlation with coercive measures per month and bed (Spearman's Rho = 0.56, p < 0.01). Discussion: Our findings that coercion varies widely within a country and mainly is associated with involuntarily admitted and aggressive patients are in line with the international literature. We believe that we included a sample that covers the scope of mental health care practice in Germany well.Clinical trial registration: www.isrctn.com, identifier ISRCTN71467851.

Prevention of First-Episode Psychosis in People at Clinical High Risk: A Randomized Controlled, Multicentre Trial Comparing Cognitive-Behavioral Therapy and Clinical Management Plus Low-Dose Aripiprazole or Placebo (PREVENT).

BACKGROUND: There is limited knowledge of whether cognitive-behavioral therapy (CBT) or second-generation antipsychotics (SGAs) should be recommended as the first-line treatment in individuals at clinical high risk for psychosis (CHRp). HYPOTHESIS: To examine whether individual treatment arms are superior to placebo and whether CBT is non-inferior to SGAs in preventing psychosis over 12 months of treatment. STUDY DESIGN: PREVENT was a blinded, 3-armed, randomized controlled trial comparing CBT to clinical management plus aripiprazole (CM + ARI) or plus placebo (CM + PLC) at 11 CHRp services. The primary outcome was transition to psychosis at 12 months. Analyses were by intention-to-treat. STUDY RESULTS: Two hundred eighty CHRp individuals were randomized: 129 in CBT, 96 in CM + ARI, and 55 in CM + PLC. In week 52, 21 patients in CBT, 19 in CM + ARI, and 7 in CM + PLC had transitioned to psychosis, with no significant differences between treatment arms (P = .342). Psychopathology and psychosocial functioning levels improved in all treatment arms, with no significant differences. CONCLUSIONS: The analysis of the primary outcome transition to psychosis at 12 months and secondary outcomes symptoms and functioning did not demonstrate significant advantages of the active treatments over placebo. The conclusion is that within this trial, neither low-dose aripiprazole nor CBT offered additional benefits over clinical management and placebo.

Predictors of the use of restraint in inpatient psychiatric care among patients admitted via the emergency department.

BACKGROUND: Coercive measures are associated with negative consequences for both patients and hospital staff. The aim of the study was to identify predictors for the use of restraints in the emergency department and in subsequent inpatient care. METHOD: Retrospective routine clinical data of all patients admitted to the psychiatric departments of Vivantes Klinikum Am Urban in Berlin via the emergency department in 2019 was examined case-wise (n = 2584) as well as patient-wise (n = 2118). RESULTS: Of all cases admitted via the emergency department, 195 cases (7.5%) experienced restraints and restraints combined with drug sedation during their inpatient treatment. Of the 2584 cases admitted via the emergency department, 195 cases (7.5%) experienced restraints and restraints combined with drug sedation during their inpatient treatment. These 195 cases experienced a total of 358 restraints and were distributed across 159 individuals. Multivariate regression analyses on patient-level show that age (p < .001), judicial placement (p < .001), and police referral in the presence of others (p < .001) had a statistically significant effect on the use of restraint. DISCUSSION: The results indicate that certain patient characteristics increase the risk of restraints. A majority of the findings of this study underline previous research findings. However, ICD-10 diagnosis and gender do not prove to be significant variables, contrary to expectations based on previous.