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临床试验/NCT01202357
NCT01202357Unknown不适用

Community Case Management for Early Psychosis: is Two Year an Optimal Duration? A Randomized Controlled Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Functioning (social and occupational)

研究概览

简要总结

A total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the EASY programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. The current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.

详细描述

Psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. In order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness.

In Hong Kong, early intervention for psychotic disorder was provided since 2001. The integrated Early Assessment Service for Young people with psychosis (EASY) provide specialized care to early psychosis patients up to age 25. Evaluation of the EASY programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis.

In the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. It is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further.

The proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. The study recruit patients who had completed the first 2 years of case management in the EASY programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. The hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder
  • Received EASY service for 2 years following a first-episode psychosis
  • Cantonese-speaking Chinese
  • Ability to understand the study and to provide written informed consent

排除标准

  • Organic brain disorder
  • Known history of intellectual disability
  • Drug-induced psychosis

结局指标

主要结局

Functioning (social and occupational)

时间窗: baseline, 12-month

次要结局

  • Symptoms, quality of life and health economics(baseline, 12-month)

研究者

申办方类型
Other

研究点 (1)

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