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临床试验/NCT02916303
NCT02916303Unknown不适用

Cost-effectiveness of Early Intervention in First-episode Psychosis: Economic Evaluation of the PAFIP Program at Medium and Long-term

Fundación Marques de Valdecilla1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
490
试验地点
1
主要终点
Cost of pharmacological and non-pharmacological treatments in monetary units (€)

研究概览

简要总结

Schizophrenia has very significant economic consequences. Costs fall on many different parts of society, especially on individuals with schizophrenia and their families. The first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. In addition, if left untreated for a long time, psychosis can impact many areas of a person's life. The evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. The provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. Only a few international studies, and none conducted in Spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from First Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode non-affective psychosis in Spain to date.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for a principal diagnosis of schizophreniform, schizophrenia, schizoaffective, brief reactive psychosis, or psychosis non otherwise specified.
  • Living in the catchment area.
  • No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
  • Current psychotic symptoms of moderate severity or greater assessed by one of the five items of the Scale for the Assessment of Positive Symptoms (SAPS).
  • First episode patients with at least one assessement at 3 years or 10 years.

排除标准

  • Meeting DSM-IV criteria for mental retardation.
  • Meeting DSM-IV criteria for drug dependence.

结局指标

主要结局

Cost of pharmacological and non-pharmacological treatments in monetary units (€)

时间窗: 3 years and 10 years

次要结局

  • Cost of suicide attempt in monetary units (€)(3 years and 10 years)
  • Cost of inpatient treatment in monetary units (€)(3 years and 10 years)
  • Burden of unemployment rate in monetary units (€)(3 years and 10 years)
  • Expenditure in transportation in monetary units (€)(3 years and 10 years)

研究者

发起方
Fundación Marques de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedicto Crespo-Facorro

Professor of Psychiatry

Fundación Marques de Valdecilla

研究点 (1)

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