The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18–65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the ‘empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders’ (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

中文翻译：

---

实施严重精神疾病患者心理社会干预循证（S3）指南（IMPPETUS）的患者版本：整群随机对照试验的研究方案

德国针对严重精神障碍患者的心理社会干预指南建议采用广泛的循证治疗。迄今为止，还缺少相关患者版本指南的结构化实施。该研究旨在评估患者指南的结构化实施是否可以改善严重精神障碍患者的赋权，以及有关心理社会干预、服务使用、治疗满意度、治疗需求、生活质量和护理负担的知识、态度和经验。该研究是一项多中心、整群随机对照研究，有两个平行组。患有严重精神障碍的住院患者和日间医院患者（所有性别；18-65 岁）将包括在内。此外，精神障碍患者的亲属（所有性别；≥ 18 岁）也将包括在内。在实验组中，将使用多模式策略实施患者指南。对照组的参与者将照常接受治疗，但将了解患者指南。主要结果是赋权的变化，通过使用“情感和精神分裂症患者精神治疗过程中的赋权”（EPAS）量表进行评估。此外，有关心理社会干预的知识、态度和经验将作为次要结果进行评估，以及服务使用、护理满意度、患者需求和生活质量以及参与和社会包容。对于亲属来说，感知到的护理负担也将被记录。将使用分层线性模型对结果进行分析。对于健康经济评估，将使用研究组之间疾病总成本的差异和质量调整生命年（QALY）的差异来计算增量成本效用比。该研究将是第一个评估患者版精神病治疗指南的结构化实施效果的研究。该研究在将结果转移到其他患者和其他地区方面存在一些局限性。此外，研究期间可能会出现招募患者和亲属以及实施干预措施的问题。该研究已在德国临床试验注册中心（DRKS）和世界卫生组织国际临床试验注册平台（ICTRP）注册，注册号为DRKS00017577（注册日期：2019年10月23日）。