Section of Psychiatry, Department of Public Health and Community Medicine, University of Verona and Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Trials. 2012 May 30;13:73. doi: 10.1186/1745-6215-13-73.
Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services.
METHODS/DESIGN: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.
针对首发精神病（FEP）的多元素干预措施很有前景，但这些措施大多在非流行病学代表性样本中进行，因此有可能低估在“真实世界”服务中治疗 FEP 的复杂性。
方法/设计：精神病早期干预和需求及结果评估（PIANO）试验是更大的研究计划（遗传学、内表型和治疗：理解早期精神病 - GET UP）的一部分，该计划旨在比较，在 9 个月时，多成分心理社会干预与常规治疗（TAU）在从意大利两个完整地区的所有公共社区心理健康中心（CMHC）招募的 FEP 患者及其家庭成员中，以及在佛罗伦萨、米兰和博尔扎诺市的大型流行病学队列中的有效性。GET UP PIANO 试验具有实用的集群随机对照设计。随机单位（集群）是 CMHC，观察单位是中心的患者及其家属。实验组患者将接受 TAU 加：1）认知行为治疗课程，2）家庭成员的心理教育课程，3）病例管理。患者招募将在一年内进行。在基线和随访时将评估几个精神病理学、心理学、功能和服务使用变量。主要结果是：1）从基线到随访的阳性和阴性症状严重程度和主观评估的变化；2）从基线到随访的复发发生情况，即导致入院和/或任何病例记录重新出现阳性精神病症状的发作。预计招募的患者人数约为 400 人，亲属人数约为 300 人。由于干预措施在 CMHC 层面实施，因此不可能对患者、临床医生和评估者进行盲法，但将尽一切努力保持评估者的独立性。我们预计这项研究将为 FEP 的最佳治疗方法提供证据，并确定可能阻碍其在“真实世界”临床环境中可行性的障碍、可能使这种干预无效或不适当的患者/家庭条件，以及临床、心理、环境和服务组织预测治疗效果、依从性和服务满意度。
