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Abstract Background Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user’s home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. Methods/design The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders’ experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical ‘twins’ receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. Discussion By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. Trial registration Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.

BackgroundMindfulness-based interventions are promising psychological treatment approaches that may have more substantial long-lasting intervention effects than cognitive behavioral therapy when treating individuals with early psychosis. A pilot study analyzed mindfulness-based inpatient group therapy’s feasibility and potential efficacy (Feel-Good).ObjectiveThis paper explores the subjective experiences of participants in the Feel-Good inpatient therapy group to gain insight into the possible changes brought about by the mindfulness-based intervention.MethodsA semi-structured change interview was used to examine the experience of ten participants who participated in the Feel-Good intervention and the additional qualitative assessment. The interviews were conducted 16 weeks after the Feel-Good group ended (16-week Follow-Up). Interviews were transcribed verbatim and analyzed using thematic analysis.ResultsThe analysis generated five themes—one about personal changes brought about by the Feel-Good group, three about the group therapy experience, and one about wishes/modification suggestions to change and improve the Feel-Good group. The findings suggested that the Feel-Good group was perceived as very helpful, leading to numerous changes in one’s overall well-being and relation to emotions. However, patients recommended a more directive therapeutic style and reduced time required for study assessments.ConclusionGathering qualitative insight from participants on the Feel-Good intervention revealed meaningful insight into patients’ experience of change processes. In addition, participant suggestions help to improve the intervention and study design to increase therapy attendance rates and treatment satisfaction, potentially increasing treatment effectiveness in the future.Clinical trial registrationClinicalTrials.gov, identifier NCT04592042.

BackgroundThe Collaborative Outcome study on Health and Functioning during Infection Times (COH-FIT; www.coh-fit.com) is an anonymous and global online survey measuring health and functioning during the COVID-19 pandemic. The aim of this study was to test concurrently the validity of COH-FIT items and the internal validity of the co-primary outcome, a composite psychopathology "P-score".MethodsThe COH-FIT survey has been translated into 30 languages (two blind forward-translations, consensus, one independent English back-translation, final harmonization). To measure mental health, 1-4 items ("COH-FIT items") were extracted from validated questionnaires (e.g. Patient Health Questionnaire 9). COH-FIT items measured anxiety, depressive, post-traumatic, obsessive-compulsive, bipolar and psychotic symptoms, as well as stress, sleep and concentration. COH-FIT Items which correlated r ≥ 0.5 with validated companion questionnaires, were initially retained. A P-score factor structure was then identified from these items using exploratory factor analysis (EFA) and confirmatory factor analyses (CFA) on data split into training and validation sets. Consistency of results across languages, gender and age was assessed.ResultsFrom >150,000 adult responses by May 6th, 2022, a subset of 22,456 completed both COH-FIT items and validated questionnaires. Concurrent validity was consistently demonstrated across different languages for COH-FIT items. CFA confirmed EFA results of five first-order factors (anxiety, depression, post-traumatic, psychotic, psychophysiologic symptoms) and revealed a single second-order factor P-score, with high internal reliability (ω = 0.95). Factor structure was consistent across age and sex.ConclusionsCOH-FIT is a valid instrument to globally measure mental health during infection times. The P-score is a valid measure of multidimensional mental health.

Abstract Background Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies. Early intervention programs for people in the first 5 years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. Methods The SEEearly trial compares treatment as usual (TAU) plus SEE to TAU alone in outpatient psychiatric settings. The study is a six-site, two-arm, single-blinded, superiority randomized controlled trial (RCT). Participants are randomly assigned (1:1) to the intervention or control group. Aiming to recruit 184 participants, with an assumed drop-out rate of 22%, we will be able to detect a 24% difference in the main outcome of employment/education with 90% power. We make assessments at baseline and at 6- and 12-month follow-ups. Outcome data on employment/education, medication, and current psychiatric treatment is obtained monthly through phone based short assessments. The primary outcome is steady participation for at least 50% of the 12-month follow-up in competitive employment and/or mainstream education. Secondary employment outcomes capture length of employment/education, time to first employment/education, monthly wages/educational attainment, and social return on investment (SROI). Secondary non-employment outcomes include subjective quality of life, psychopathology, substance use, relapse, hospitalization, and functional impairment. To be eligible, participants must be between 16 and 35 years, fulfill diagnostic criteria for early psychosis, and be interested in competitive employment and/or mainstream education. Discussion In SEEearly, we hypothesize that participants with psychosis, who receive TAU plus SEE, present with better primary and secondary outcomes than participants, who receive TAU alone. Positive results of this study will justify SEE as an evidence-based strategy for clinical routine treatment in people with early psychosis. Trial registration SEEearly was registered nationally and internationally in the German Clinical Trials Register (DRKS; identifier: DRKS00029660) on October 14, 2022.

Abstract Background It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion on psychotherapy in psychotic disorders, and to help implement psychotherapy in routine care. Furthermore, the study will allow drawing conclusions about the mediators of treatment effects of CBT of psychotic disorders. Trial Registration Current Controlled Trials ISRCTN29242879

Summary: 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.

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.

IntroductionThe 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.MethodsFifty 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.ResultsThe 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

Abstract We will give an overview of the status of early intervention services for psychosis in Germany. We recently established a website which provides people in Germany with the nearest early detection an intervention service available (https://www.psycho-check.com). However, the overall implementation rate of early detction in Germany is quite heterogenous. We will also present recent research and ongoing projects from Germany including the first evaluation of specialized inpatient services for early psychosis, first evaluations of Individual placement and support and a mindfulness based group intervention in people with early psychosis as well as a newly desigend youth mental health service called soulspace (www.soulspace-berlin.de). Disclosure of Interest None Declared

Background: Mindfulness-based interventions are promising psychological treatment approaches that may have more substantial long-lasting intervention effects than cognitive behavioral therapy when treating individuals with early psychosis. A pilot study analyzed mindfulness-based inpatient group therapy's feasibility and potential efficacy (Feel-Good). Objective: This paper explores the subjective experiences of participants in the Feel-Good inpatient therapy group to gain insight into the possible changes brought about by the mindfulness-based intervention. Methods: A semi-structured change interview was used to examine the experience of ten participants who participated in the Feel-Good intervention and the additional qualitative assessment. The interviews were conducted 16 weeks after the Feel-Good group ended (16-week Follow-Up). Interviews were transcribed verbatim and analyzed using thematic analysis. Results: The analysis generated five themes--one about personal changes brought about by the Feel-Good group, three about the group therapy experience, and one about wishes/modification suggestions to change and improve the Feel-Good group. The findings suggested that the Feel-Good group was perceived as very helpful, leading to numerous changes in one's overall well-being and relation to emotions. However, patients recommended a more directive therapeutic style and reduced time required for study assessments. Conclusion: Gathering qualitative insight from participants on the Feel-Good intervention revealed meaningful insight into patients' experience of change processes. In addition, participant suggestions help to improve the intervention and study design to increase therapy attendance rates and treatment satisfaction, potentially increasing treatment effectiveness in the future. [ABSTRACT FROM AUTHOR]

IntroductionThe use of restraint as a means of managing patients is considered a critical factor that interferes with recovery. Strategies to create a less restrictive environment within psychiatric facilities are therefore eagerly sought. Peer support workers (PSWs) are increasingly employed in mental health settings. The prevailing theory is that PSWs have the potential to contribute to conflict and restraint prevention efforts in acute psychiatric wards. However, to date, research in support of this claim remains limited.ObjectiveThe present study aimed at assessing the effectiveness of employing peer support workers with regard to reducing the use of restraint.MethodsThis prospective controlled pre–post study sought to evaluate the implementation of peer support in one locked ward compared to treatment as usual (TAU) with no implementation of peer support in a second locked ward of a psychiatry department in Berlin, Germany. The pre–post comparison was planned to consist of two assessment periods of 3 months each, taking place directly before and after peer support implementation or TAU. Both assessments were extended to a period of 6 months, before and after the initially planned 12-month implementation process, in order to balance the effects of disruptions and of the COVID-19 pandemic. Using routine data, the proportion, frequency, and duration of mechanical restraint, forced medication as well as mechanical restraint in combination with forced medication, were evaluated.ResultsIn the control group, an increase in the proportion of patients subjected to measures of restraint was found between pre- and post-assessment, which was accompanied by a further increase in the mean number of events of restraint per patient within this group. In the intervention group, no significant change in the application of restraint was observed during the study period.DiscussionThere is some indication that peer support may be protective with regard to restraint in acute wards. However, our study faced major challenges during the implementation process and the post-assessment period, such as COVID-19 and staff reorganization. This may have led to peer support not reaching its full potential. The relationship between the implementation of peer support and the use of restraint therefore merits further investigation.

Abstract 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.

BackgroundOver the last decade, researchers have sought for alternative interventions that have better treatment effects than Cognitive Behavioral Therapy (CBT) when treating psychotic symptoms. Mindfulness-based interventions have been a proposed alternative to CBT, yet research regarding its feasibility, acceptance and effectiveness is lacking when treating individuals with early psychosis in inpatient settings.ObjectiveBefore conducting a large-scale randomized-controlled trial (RCT), this pilot study evaluated the feasibility and the potential efficacy of a mindfulness-based inpatient group intervention that targets emotion regulation in patients with early psychosis, and thus indirectly improving psychotic symptoms.MethodsA pre–post study was performed. Thirty-six patients with early psychosis treated at the specialized inpatient treatment “Frühinterventions- und Therapiezentrum; FRITZ” (early intervention and therapy center) received eight group therapy sessions. Assessments were performed at baseline, after 8 weeks post treatment and at follow-up after 16 weeks.ResultsRates of patients who participated in the study suggests that a mindfulness-based group therapy is highly accepted and feasible for patients with early psychosis being treated in an inpatient ward. Friedman analyses revealed significant changes in the primary outcomes of emotional goal attainment (Goal 1: W = 0.79; Goal 2: W = 0.71) and psychotic symptoms (PANSS-T: W = 0.74). Significant, albeit small, effect sizes were found in patients’ self-perception of emotion regulation skills (ERSQ: W = 0.23).DiscussionWe found favorable findings regarding the feasibility and acceptance of the Feel-Good mindfulness-based intervention. Results of the study provide a basis for an estimation of an adequate sample size for a fully powered RCT that needs to be conducted to test whether Feel-Good is effective in the inpatient treatment of psychotic symptoms for individuals with early psychosis.Clinical trial registration[https://clinicaltrials.gov/ct2/show/NCT04592042], identifier [NCT04592042].

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.