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1.
Article De | MEDLINE | ID: mdl-38718816

Schizophrenia is accompanied by significant cognitive impairments, which often persist to a relevant extent after remission of clinical symptoms and has a negative impact on psychosocial functioning. These impairments are often experienced as very stressful by those affected. Under the umbrella term of Cognitive Remediation Therapy (CRT), evidence-based therapy options are available that improve both the respective cognitive target functions and the psychosocial functioning. According to expert recommendations, at least 20 sessions should be carried out, accompanied by qualified therapeutic staff. The current edition of the S3 treatment guideline schizophrenia of the German Society for Psychiatry and Psychotherapy, Psychosomatics and Neurology recommends CRT with the highest level of recommendation. It is unclear to what extent CRT has become part of routine inpatient care. Between July 2021 and May 2022, 395 psychiatric university hospitals and non-university psychiatric specialist hospitals in Germany were invited to fill in a 14-item questionnaire. A total of 103 institutions took part in the survey; 56.3% of these hospitals used at least one evidence-based CRT programme. Among the CRT programmes used, Cogpack, Rehacom and the Integriertes Psychologisches Therapieprogramm (IPT) were named most frequently. In 87.5% of the participating facilities, fewer than half of the people with schizophrenia received CRT. With regard to the clinics which used evidence-based CRT, 64.3% carried out fewer than 11 therapy sessions, 28.6% between 11 and 20 sessions and 7.2% more than 20 sessions. It is thus clear that CRT is not yet offered in all of the participating psychiatric hospitals in Germany, not yet for all people with schizophrenia, and not yet with sufficient intensity, with clinics indicating the need for more technical and personnel resources and more extensive development of competencies for CRT application.The low response rate of 26.1% and possible selection effects for participation in the study are addressed and are to be seen as limitations.

2.
World J Biol Psychiatry ; 25(4): 233-241, 2024 Apr.
Article En | MEDLINE | ID: mdl-38493362

BACKGROUND: The evidence for repetitive transcranial magnetic stimulation (rTMS) to treat negative symptoms in schizophrenia (SCZ) is increasing, although variable response rates remain a challenge. Subject´s sex critically influences rTMS´ treatment outcomes. Females with major depressive disorder are more likely to respond to rTMS, while SCZ data is scarce. METHODS: Using data from the 'rTMS for the Treatment of Negative Symptoms in Schizophrenia' (RESIS) trial we assessed the impact of sex on rTMS´ clinical response rate from screening up to 105 days after intervention among SCZ patients. The impact of resting motor threshold (RMT) on response rates was also assessed. RESULTS: 157 patients received either active or sham rTMS treatment. No significant group differences were observed. Linear mixed model showed no effects on response rates (all p > 0.519). Apart from a significant sex*time interaction for the positive subscale of the positive and negative syndrome scale (PANSS) scores (p = 0.032), no other significant effects of sex on continuous PANSS scores were observed. RMT had no effect on response rate. CONCLUSION: In the largest rTMS trial on the treatment of SCZ negative symptoms we did not observe any significant effect of sex on treatment outcomes. Better assessments of sex-related differences could improve treatment individualisation.


Schizophrenia , Transcranial Magnetic Stimulation , Humans , Schizophrenia/therapy , Schizophrenia/physiopathology , Female , Male , Adult , Middle Aged , Sex Factors , Treatment Outcome , Psychiatric Status Rating Scales
3.
Schizophr Res ; 264: 1-28, 2024 Feb.
Article En | MEDLINE | ID: mdl-38086109

With new data about different aspects of schizophrenia being continually generated, it becomes necessary to periodically revisit exactly what we know. Along with a need to review what we currently know about schizophrenia, there is an equal imperative to evaluate the construct itself. With these objectives, we undertook an iterative, multi-phase process involving fifty international experts in the field, with each step building on learnings from the prior one. This review assembles currently established findings about schizophrenia (construct, etiology, pathophysiology, clinical expression, treatment) and posits what they reveal about its nature. Schizophrenia is a heritable, complex, multi-dimensional syndrome with varying degrees of psychotic, negative, cognitive, mood, and motor manifestations. The illness exhibits a remitting and relapsing course, with varying degrees of recovery among affected individuals with most experiencing significant social and functional impairment. Genetic risk factors likely include thousands of common genetic variants that each have a small impact on an individual's risk and a plethora of rare gene variants that have a larger individual impact on risk. Their biological effects are concentrated in the brain and many of the same variants also increase the risk of other psychiatric disorders such as bipolar disorder, autism, and other neurodevelopmental conditions. Environmental risk factors include but are not limited to urban residence in childhood, migration, older paternal age at birth, cannabis use, childhood trauma, antenatal maternal infection, and perinatal hypoxia. Structural, functional, and neurochemical brain alterations implicate multiple regions and functional circuits. Dopamine D-2 receptor antagonists and partial agonists improve psychotic symptoms and reduce risk of relapse. Certain psychological and psychosocial interventions are beneficial. Early intervention can reduce treatment delay and improve outcomes. Schizophrenia is increasingly considered to be a heterogeneous syndrome and not a singular disease entity. There is no necessary or sufficient etiology, pathology, set of clinical features, or treatment that fully circumscribes this syndrome. A single, common pathophysiological pathway appears unlikely. The boundaries of schizophrenia remain fuzzy, suggesting the absence of a categorical fit and need to reconceptualize it as a broader, multi-dimensional and/or spectrum construct.


Autistic Disorder , Bipolar Disorder , Psychotic Disorders , Schizophrenia , Pregnancy , Infant, Newborn , Female , Humans , Schizophrenia/diagnosis , Psychotic Disorders/diagnosis , Brain/pathology
4.
Eur Psychiatry ; 67(1): e4, 2023 Dec 13.
Article En | MEDLINE | ID: mdl-38086744

The digitalisation of mental health care is expected to improve the accessibility and quality of specialised treatment services and introduce innovative methods to study, assess, and monitor mental health disorders. In this narrative review and practical recommendation of the European Psychiatric Association (EPA), we aim to help healthcare providers and policymakers to navigate this rapidly evolving field. We provide an overview of the current scientific and implementation status across two major domains of digitalisation: i) digital mental health interventions and ii) digital phenotyping, discuss the potential of each domain to improve the accessibility and outcomes of mental health services, and highlight current challenges faced by researchers, clinicians, and service users. Furthermore, we make several recommendations meant to foster the widespread adoption of evidence-based digital solutions for mental health care in the member states of the EPA. To realise the vision of a digitalised, patient-centred, and data-driven mental health ecosystem, a number of implementation challenges must be considered and addressed, spanning from human, technical, ethical-legal, and economic barriers. The list of priority areas and action points our expert panel has identified could serve as a playbook for this process.


Mental Disorders , Mental Health Services , Humans , Mental Disorders/diagnosis , Mental Disorders/therapy , Mental Health
6.
Z Evid Fortbild Qual Gesundhwes ; 182-183: 8-16, 2023 Dec.
Article En | MEDLINE | ID: mdl-37884419

Quality indicators (QI) are becoming increasingly important in mental healthcare in Germany. QI can be used for various purposes, such as for creating transparency as well as for benchmarking between hospitals. QI themselves are subject to high quality standards. The aim of this report is to describe the development and implementation of QI in a group of psychiatric hospitals. Since 2015, the LVR hospital group has developed and gradually implemented QI for the purposes of quality measurement, quality assurance and internal benchmarking in its nine psychiatric hospitals in a comprehensive, multidisciplinary, scientifically accompanied process. The full LVR-QI set, consisting of eight structure-, twelve process- and four outcome indicators as well as one patient satisfaction questionnaire, was implemented by 2019. In order to create high documentation quality and acceptance by clinicians, various implementation and dissemination strategies were used, such as written documentation manuals, staff training as well as regular face-to-face communication between the LVR hospitals, the LVR Institute for Health Services Research as the central coordinating body and the headquarters of the LVR hospital group. The QI led to a quality-oriented dialogue within and between the LVR hospitals.


Hospitals, Psychiatric , Quality Indicators, Health Care , Humans , Germany , Benchmarking , Patient Satisfaction , Quality Assurance, Health Care
8.
Eur Psychiatry ; 66(1): e65, 2023 08 03.
Article En | MEDLINE | ID: mdl-37534402

Depressive disorders have one of the highest disability-adjusted life years (DALYs) of all medical conditions, which led the European Psychiatric Association to propose a policy paper, pinpointing their unmet health care and research needs. The first part focuses on what can be currently done to improve the care of patients with depression, and then discuss future trends for research and healthcare. Through the narration of clinical cases, the different points are illustrated. The necessary political framework is formulated, to implement such changes to fundamentally improve psychiatric care. The group of European Psychiatrist Association (EPA) experts insist on the need for (1) increased awareness of mental illness in primary care settings, (2) the development of novel (biological) markers, (3) the rapid implementation of machine learning (supporting diagnostics, prognostics, and therapeutics), (4) the generalized use of electronic devices and apps into everyday treatment, (5) the development of the new generation of treatment options, such as plasticity-promoting agents, and (6) the importance of comprehensive recovery approach. At a political level, the group also proposed four priorities, the need to (1) increase the use of open science, (2) implement reasonable data protection laws, (3) establish ethical electronic health records, and (4) enable better healthcare research and saving resources.


Depression , Mental Disorders , Humans , Mental Health
9.
Int J Neuropsychopharmacol ; 26(10): 747-760, 2023 10 19.
Article En | MEDLINE | ID: mdl-37531283

BACKGROUND: Increased levels of occupational stress among health professionals during the COVID-19 pandemic have been documented. Few studies have examined the effects of the pandemic on mental health professionals despite the heightened demand for their services. METHOD: A multilingual, longitudinal, global survey was conducted at 3 time points during the pandemic among members of the World Health Organization's Global Clinical Practice Network. A total of 786 Global Clinical Practice Network members from 86 countries responded to surveys assessing occupational distress, well-being, and posttraumatic stress symptoms. RESULTS: On average, respondents' well-being deteriorated across time while their posttraumatic stress symptoms showed a modest improvement. Linear growth models indicated that being female, being younger, providing face-to-face health services to patients with COVID-19, having been a target of COVID-related violence, and living in a low- or middle-income country or a country with a higher COVID-19 death rate conveyed greater risk for poor well-being and higher level of stress symptoms over time. Growth mixed modeling identified trajectories of occupational well-being and stress symptoms. Most mental health professions demonstrated no impact to well-being; maintained moderate, nonclinical levels of stress symptoms; or showed improvements after an initial period of difficulty. However, some participant groups exhibited deteriorating well-being approaching the clinical threshold (25.8%) and persistently high and clinically significant levels of posttraumatic stress symptoms (19.6%) over time. CONCLUSIONS: This study indicates that although most mental health professionals exhibited stable, positive well-being and low stress symptoms during the pandemic, a substantial minority of an already burdened global mental health workforce experienced persistently poor or deteriorating psychological status over the course of the pandemic.


COVID-19 , Humans , Female , Male , COVID-19/epidemiology , Pandemics , SARS-CoV-2 , Mental Health , Depression/psychology
10.
Article En | MEDLINE | ID: mdl-37581691

This study aims to investigate the barriers and facilitators to guideline adherence for the print format of the German schizophrenia guideline as well as for the concept of a digital living guideline for the first time. For this purpose, the schizophrenia guideline was transferred to a digital guideline format within the web-based tool MAGICapp. An online survey was performed under participation of mental healthcare professionals (medical doctors, psychologists/psychotherapists, psychosocial therapists, caregivers) in 17 hospitals for psychiatry in Southern Germany and a professional association for German neurologists and psychiatrists. 524 participants opened the survey, 439 completed the demographic questions and commenced the content-related survey and 309 provided complete data sets. Results indicate a higher occurrence of knowledge-related barriers for the living guideline. The print version is associated with more attitude-related and external barriers. Older professionals reported more attitude-related barriers to a living guideline compared to younger professionals. Differences between professions regarding barriers were found for both formats. Various barriers exist for both guideline formats and a need for facilitators was expressed across professions. Many of the mentioned obstacles and facilitators can be more easily addressed with living guidelines. However, also living guidelines face barriers. Thus, the introduction of these new formats alone cannot lead to sustainable behavior change regarding guideline adherence. Yet, living guidelines seem to be a cornerstone to improved and tailored guideline implementation as they facilitate to keep recommendations up to date and to address the need of individual professional groups.

11.
BMC Psychiatry ; 23(1): 548, 2023 07 28.
Article En | MEDLINE | ID: mdl-37507656

BACKGROUND: Quantifying depression mainly relies on the use of depression scales, and understanding their factor structure is crucial for evaluating their validity. METHODS: This post-hoc analysis utilized prospectively collected data from a naturalistic study of 1014 inpatients with major depression. Confirmatory and exploratory factor analyses were performed to test the psychometric abilities of the Hamilton Depression Rating Scale, the Montgomery Asberg Depression Rating Scale, and the self-rated Beck Depression Inventory. A combined factor analysis was also conducted including all items of all scales. RESULTS: All three scales showed good to very good internal consistency. The HAMD-17 had four factors: an "anxiety" factor, a "depression" factor, an "insomnia" factor, and a "somatic" factor. The MADRS also had four factors: a "sadness" factor, a neurovegetative factor, a "detachment" factor and a "negative thoughts" factor, while the BDI had three factors: a "negative attitude towards self" factor, a "performance impairment" factor, and a "somatic" factor. The combined factor analysis suggested that self-ratings might reflect a distinct illness dimension within major depression. CONCLUSIONS: The factors obtained in this study are comparable to those found in previous research. Self and clinician ratings are complementary and not redundant, highlighting the importance of using multiple measures to quantify depression.


Depressive Disorder, Major , Inpatients , Humans , Reproducibility of Results , Depressive Disorder, Major/diagnosis , Anxiety , Anxiety Disorders , Psychiatric Status Rating Scales , Psychometrics
12.
Eur Psychiatry ; 66(1): e58, 2023 07 21.
Article En | MEDLINE | ID: mdl-37476977

The ongoing developments of psychiatric classification systems have largely improved reliability of diagnosis, including that of schizophrenia. However, with an unknown pathophysiology and lacking biomarkers, its validity still remains low, requiring further advancements. Research has helped establish multiple sclerosis (MS) as the central nervous system (CNS) disorder with an established pathophysiology, defined biomarkers and therefore good validity and significantly improved treatment options. Before proposing next steps in research that aim to improve the diagnostic process of schizophrenia, it is imperative to recognize its clinical heterogeneity. Indeed, individuals with schizophrenia show high interindividual variability in terms of symptomatic manifestation, response to treatment, course of illness and functional outcomes. There is also a multiplicity of risk factors that contribute to the development of schizophrenia. Moreover, accumulating evidence indicates that several dimensions of psychopathology and risk factors cross current diagnostic categorizations. Schizophrenia shares a number of similarities with MS, which is a demyelinating disease of the CNS. These similarities appear in the context of age of onset, geographical distribution, involvement of immune-inflammatory processes, neurocognitive impairment and various trajectories of illness course. This article provides a critical appraisal of diagnostic process in schizophrenia, taking into consideration advancements that have been made in the diagnosis and management of MS. Based on the comparison between the two disorders, key directions for studies that aim to improve diagnostic process in schizophrenia are formulated. All of them converge on the necessity to deconstruct the psychosis spectrum and adopt dimensional approaches with deep phenotyping to refine current diagnostic boundaries.


Multiple Sclerosis , Neurosciences , Psychotic Disorders , Schizophrenia , Humans , Schizophrenia/diagnosis , Multiple Sclerosis/diagnosis , Reproducibility of Results , Psychotic Disorders/psychology , Biomarkers
14.
J Affect Disord ; 333: 271-277, 2023 07 15.
Article En | MEDLINE | ID: mdl-37100177

AIMS: Mental disorders characterized by preoccupation with distressing bodily symptoms and associated functional impairment have been a target of major reconceptualization in the ICD-11, in which a single category of Bodily Distress Disorder (BDD) with different levels of severity replaces most of the Somatoform Disorders in ICD-10. This study compared the accuracy of clinicians' diagnosis of disorders of somatic symptoms using either the ICD-11 or ICD-10 diagnostic guidelines in an online study. METHODS: Clinically active members of the World Health Organization's Global Clinical Practice Network (N = 1065) participating in English, Spanish, or Japanese were randomly assigned to apply ICD-11 or ICD-10 diagnostic guidelines to one of nine pairs of standardized case vignettes. The accuracy of the clinicians' diagnoses as well as their ratings of the guidelines' clinical utility were assessed. RESULTS: Overall, clinicians were more accurate using ICD-11 compared to ICD-10 for every presentation of a vignette characterized primarily by bodily symptoms associated with distress and impairment. Clinicians who made a diagnosis of BDD using ICD-11 were generally correct in applying the severity specifiers for the condition. LIMITATIONS: This sample may represent some self-selection bias and thus may not generalize to all clinicians. Additionally, diagnostic decisions with live patients may lead to different results. CONCLUSIONS: The ICD-11 diagnostic guidelines for BDD represent an improvement over those for Somatoform Disorders in ICD-10 in regard to clinicians' diagnostic accuracy and perceived clinical utility.


International Classification of Diseases , Medically Unexplained Symptoms , Humans , Neurasthenia , Somatoform Disorders/diagnosis , Case-Control Studies
15.
Schizophr Bull ; 49(4): 1055-1066, 2023 07 04.
Article En | MEDLINE | ID: mdl-37021666

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.


Antipsychotic Agents , Cognitive Behavioral Therapy , Psychotic Disorders , Humans , Aripiprazole/pharmacology , Aripiprazole/therapeutic use , Psychotic Disorders/drug therapy , Psychotic Disorders/prevention & control , Antipsychotic Agents/pharmacology , Antipsychotic Agents/therapeutic use , Knowledge , Treatment Outcome
17.
Eur Arch Psychiatry Clin Neurosci ; 273(7): 1587-1598, 2023 Oct.
Article En | MEDLINE | ID: mdl-36808533

The implementation status of clinical guidelines is, despite their important role in connecting research with practice, frequently not satisfactory. This study aims to investigate the implementation status of the current German guideline for schizophrenia. Moreover, the attitude toward a living guideline has been explored for the first time by presenting screenshots of the German schizophrenia guideline transferred to a digital living guideline format called MAGICapp. A cross-sectional online survey was performed under the participation of 17 hospitals for psychiatry and psychosomatic medicine in Southern Germany and one professional association for German neurologists and psychiatrists. 439 participants supplied sufficient data for analysis. 309 provided complete data sets. Regarding the current guideline for schizophrenia and key recommendations, a large awareness-to-adherence gap was found. Group comparisons between different professions (caregivers, medical doctors, psychologists/psychotherapists, psychosocial therapists) detected differences in the implementation status showing higher awareness and agreement with the schizophrenia guideline and its key recommendations among medical doctors compared to psychosocial therapists and caregivers. Moreover, we detected differences in the implementation status of the guideline as a whole and its key recommendations between specialist and assistant doctors. The attitude toward an upcoming living guideline was mostly positive, especially among younger healthcare professionals. Our findings confirm an awareness-to-adherence gap, not only for the current schizophrenia guideline in general but also for its key recommendations with apparent differences between professions. Overall, our results show promising positive attitudes toward the living guideline for schizophrenia among healthcare providers, suggesting that a living guideline may be a supportive tool in everyday clinical practice.


Psychiatry , Schizophrenia , Humans , Schizophrenia/diagnosis , Schizophrenia/therapy , Cross-Sectional Studies , Germany , Attitude
18.
Eur Psychiatry ; 65(1): e57, 2022 09 05.
Article En | MEDLINE | ID: mdl-36059103

BACKGROUND: Although cognitive impairment is a core symptom of schizophrenia related to poorer outcomes in different functional domains, it still remains a major therapeutic challenge. To date, no comprehensive treatment guidelines for cognitive impairment in schizophrenia are implemented. METHODS: The aim of the present guidance paper is to provide a comprehensive meta-review of the current available evidence-based treatments for cognitive impairment in schizophrenia. The guidance is structured into three sections: pharmacological treatment, psychosocial interventions, and somatic treatments. RESULTS: Based on the reviewed evidence, this European Psychiatric Association guidance recommends an appropriate pharmacological management as a fundamental starting point in the treatment of cognitive impairment in schizophrenia. In particular, second-generation antipsychotics are recommended for their favorable cognitive profile compared to first-generation antipsychotics, although no clear superiority of a single second-generation antipsychotic has currently been found. Anticholinergic and benzodiazepine burdens should be kept to a minimum, considering the negative impact on cognitive functioning. Among psychosocial interventions, cognitive remediation and physical exercise are recommended for the treatment of cognitive impairment in schizophrenia. Noninvasive brain stimulation techniques could be taken into account as add-on therapy. CONCLUSIONS: Overall, there is definitive progress in the field, but further research is needed to develop specific treatments for cognitive impairment in schizophrenia. The dissemination of this guidance paper may promote the development of shared guidelines concerning the treatment of cognitive functions in schizophrenia, with the purpose to improve the quality of care and to achieve recovery in this population.


Antipsychotic Agents , Cognitive Dysfunction , Schizophrenia , Antipsychotic Agents/therapeutic use , Benzodiazepines/therapeutic use , Cholinergic Antagonists/therapeutic use , Cognitive Dysfunction/etiology , Cognitive Dysfunction/therapy , Humans , Schizophrenia/complications , Schizophrenia/drug therapy , Schizophrenic Psychology
19.
Eur Psychiatry ; 65(1): e58, 2022 09 05.
Article En | MEDLINE | ID: mdl-36059109

BACKGROUND: Impairment in a wide range of cognitive abilities has been consistently reported in individuals with schizophrenia. Both neurocognitive and social cognitive deficits are thought to underlie severe functional disabilities associated with schizophrenia. Despite the key role in schizophrenia outcome, cognition is still poorly assessed in both research and clinical settings. METHODS: In this guidance paper, we provide a systematic review of the scientific literature and elaborate several recommendations for the assessment of cognitive functions in schizophrenia both in research settings and in real-world clinical practice. RESULTS: Expert consensus and systematic reviews provided guidance for the optimal assessment of cognitive functions in schizophrenia. Based on the reviewed evidence, we recommend a comprehensive and systematic assessment of neurocognitive and social cognitive domains in schizophrenia, in all phases of the disorder, as well as in subjects at risk to develop psychosis. This European Psychiatric Association guidance recommends not only the use of observer reports but also self-reports and interview-based cognitive assessment tools. The guidance also provides a systematic review of the state of the art of assessment in the first episode of psychosis patients and in individuals at risk for psychosis. CONCLUSION: The comprehensive review of the evidence and the recommendations might contribute to advance the field, allowing a better cognitive assessment, and avoiding overlaps with other psychopathological dimensions. The dissemination of this guidance paper may promote the development of shared guidelines concerning the assessment of cognitive functions in schizophrenia, with the purpose to improve the quality of care and to obtain recovery.


Cognition Disorders , Cognitive Dysfunction , Psychotic Disorders , Schizophrenia , Cognition Disorders/psychology , Cognitive Dysfunction/complications , Cognitive Dysfunction/etiology , Humans , Neuropsychological Tests , Psychotic Disorders/psychology , Schizophrenia/complications , Schizophrenia/diagnosis , Schizophrenic Psychology
20.
Trials ; 23(1): 807, 2022 Sep 24.
Article En | MEDLINE | ID: mdl-36153555

BACKGROUND: Despite high acceptance rates in the field, the implementation of the 2019 published German evidence and consensus-based S3 guideline is unsatisfactory. This study aims to assess the superiority of an adaptive online version with a better visualization of the recommendations in terms of guideline conformity, application of shared decision making, and digital health expertise compared to the classic pdf print version of the guideline. METHODS: The study is a multicenter, controlled, cluster-randomized trial with two arms: one arm investigating the implementation of the German schizophrenia guideline in form of a digital format (intervention group using the evidence ecosystem MAGICapp), the other arm in form of the classic print pdf version (control group). Physicians and psychologists working in specialized hospitals will be included in the study. The guideline-knowledge before and after the intervention is defined as primary outcome measure. Secondary endpoints include digital health expertise and application of shared decision making. DISCUSSION: This is the first study evaluating if an adaptive-digital version of the schizophrenia guideline is superior to the classic pdf print version. Therefore, the guideline is digitally prepared in the evidence-ecosystem MAGICapp, which covers the whole process of the development of a living guideline. We intend to use the results of the cluster-randomized trial for developing the German S3 guideline for schizophrenia in form of a living guideline in future. TRIAL REGISTRATION: The study is registered (10 May 2022) in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00028895 .


Schizophrenia , Ecosystem , Guideline Adherence , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Schizophrenia/drug therapy , Schizophrenia/therapy
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