The RAISE early treatment program for first-episode psychosis: background, rationale, and study design.
The RAISE early treatment program for first-episode psychosis: background, rationale, and study design.
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DOI：
10.4088/jcp.14m09289
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发表时间：
2015-03
期刊：
影响因子：
--
通讯作者：
Robinson DG
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文献类型：
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作者：
Kane JM;Schooler NR;Marcy P;Correll CU;Brunette MF;Mueser KT;Rosenheck RA;Addington J;Estroff SE;Robinson J;Penn DL;Robinson DG
NIMH RAISE-ETP（早期治疗计划）的前提是由训练有素的多学科团队提供联合收割机最先进的药理学和心理社会治疗，以显着改善首发精神病患者的功能结局和生活质量。该研究是在非学术（“真实的世界”）治疗环境中进行的，主要使用现存的报销机制。我们在广泛的文献回顾和专家咨询的基础上制定了一个治疗模式和培训计划。我们的主要目的是比较实验性干预与“常规护理”对生活质量的影响。次要目标包括缓解、恢复和成本效益的比较。根据DSM IV，首次发作精神分裂症、情感性精神障碍、精神分裂症样障碍、精神病性障碍NOS或短暂精神病性障碍且抗精神病药物治疗不超过6个月的15-40岁患者合格。患者随访至少两年，主要评估由设盲的集中评估者使用实时双向视频进行。我们选择了21个州的34个临床研究中心，并利用聚类随机化将17个分配给实验治疗，17个分配给常规治疗。入组于2009年7月开始，2011年7月结束，共入组404例受试者。试验结果将另行公布。本文的目的是介绍干预的总体发展和临床试验的设计，以评估其有效性。我们相信，我们已经成功地设计了一种多模式治疗干预，可以在真实的世界的临床环境中提供，并实施了一项对照临床试验，可以提供必要的结果数据，以确定其对早期精神分裂症的轨迹的影响。
The premise of the NIMH RAISE-ETP (Early Treatment Program) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team, in order to significantly improve the functional outcome and quality of life for first episode psychosis patients. The study is being conducted in non-academic (“real world’) treatment settings, using primarily extant reimbursement mechanisms. We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to “usual care” on quality of life. Secondary aims include comparisons on remission, recovery and cost effectiveness. Patients 15–40 years old with a first episode of schizophrenia; schizoaffective disorder; schizophreniform disorder, psychotic disorder NOS, or brief psychotic disorder according to DSM IV and no more than six months of antipsychotic medications were eligible. Patients are followed for a minimum of two years, with major assessments conducted by blinded, centralized raters using live, two-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 to the experimental treatment and 17 to usual care. Enrollment began in July, 2009 and ended in July 2011 with 404 subjects. The results of the trial will be published separately. The goal of the paper is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness. We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real world clinical settings and implementing a controlled clinical trial which can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.