Schandrin Aurélie, Jourdan Julie, Chkair Sihame, Bouvet Sophie, Fabbro-Peray Pascale, Abbar Mocrane
Department of Adult Psychiatry, CHU Nîmes, Univ Montpellier, Nîmes, France.
Department of Biostatistics, Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Univ Montpellier, Nîmes, France.
BMC Psychiatry. 2025 May 15;25(1):488. doi: 10.1186/s12888-025-06940-y.
Early intervention services (EIS) for early psychosis can help reduce the patient-specific and economic impacts of mental illness, but they are underdeveloped and practices are poorly harmonized in many countries.
The aim of the study is to evaluate in France the effectiveness of a three-year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in young people with a first episode of psychosis (FEP). Eligible participants are those aged between 16 and 30 years old consulting or hospitalized in mental health services for a FEP. Exclusion criteria include mental retardation, psychosis due to medication or medical condition. Four centers have so far joined the study and started recruiting. In this randomized controlled trial, the interventional group will receive TAU with the addition of intensive follow-up by a case manager, in accordance with EPPIC guidelines. The primary outcome is the percentage of participants relapsing at least once during the three-year follow-up, and time until first relapse. Secondary outcomes are relapse and hospitalization rate, adherence to care, clinical outcomes (psychotic et depressive symptoms, suicidal and aggressive behaviors, substance use), functional outcomes (living conditions, level of study or employment, social and occupational functioning), quality of life (patients and caregivers), users' satisfaction, direct and indirect costs and correct implementation of the intervention.
The results from this study will be invaluable in characterizing the role of early intervention and case management, and establishing optimal care protocols to treat early psychosis in France. The study has encountered problems in attracting recruiting centers often to commit to randomization. The medico-economic evaluation is a strength of the study, as economic objectives are too infrequently considered in such studies.
www.
gov number NCT05116514 registered on 05/10/2021.
早期精神病的早期干预服务（EIS）有助于减少精神疾病对患者个体及经济方面的影响，但在许多国家，这些服务尚不完善，且实践缺乏协调性。
本研究旨在评估在法国，针对首次发作精神病（FEP）的年轻人，一项基于个案管理的为期三年的早期精神病项目（PEPsy-CM）相对于常规治疗（TAU）的有效性。符合条件的参与者为年龄在16至30岁之间、因FEP在精神卫生服务机构就诊或住院的患者。排除标准包括智力发育迟缓、药物或躯体疾病所致精神病。目前已有四个中心加入该研究并开始招募。在这项随机对照试验中，干预组将接受常规治疗，并根据EPPIC指南增加个案管理员的强化随访。主要结局是在三年随访期间至少复发一次的参与者百分比以及首次复发的时间。次要结局包括复发率和住院率、治疗依从性、临床结局（精神病性及抑郁症状、自杀和攻击行为、物质使用情况）、功能结局（生活状况、学习或就业水平、社会和职业功能）、生活质量（患者及照料者）、使用者满意度、直接和间接成本以及干预措施的正确实施情况。
本研究结果对于明确早期干预和个案管理的作用，以及制定法国早期精神病的最佳治疗方案将具有重要价值。该研究在吸引招募中心参与随机分组方面遇到了问题。医学经济学评估是本研究的一个优势，因为在此类研究中经济目标很少被考虑。
www.
gov编号NCT05116514，于2021年10月5日注册。
