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临床试验/NCT00919620
NCT00919620已完成不适用

Outcome of Stage-specific Early Intervention for Psychosis in Hong Kong: A Randomized Controlled Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
1
主要终点
Functioning (social and occupational)

研究概览

简要总结

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.

详细描述

Psychotic disorder is a debilitating illness which imposes substantial impact to the patients, their families, and the society. The provision of early intervention provides a window of opportunity to minimize the social and economic burden incurred by the illness.

Many previous studies of effectiveness of early intervention used the historical control approach and are subjected to cohort effects. For example, change of medication pattern over time could potentially lead to differences in outcome. In addition, few studies provide longer-term outcome data of treatment program beyond two years. The optimal length of intervention has not been determined, and many programmes used 12-24 month intervention mainly based on resources available. It is also important to ask whether favorable effects of early intervention could be sustained over time. Further analyses will be done to assess whether EI effects are more pronounced in particular subgroups including DUP, age, sex and diagnosis.

The proposed study aims to address these issues by using a randomized controlled design to investigate the longer-term (4 year) outcome of patients with first episode psychosis. The study randomizes 360 patients with first episode psychotic disorders into 3 groups: (1) standard care (outpatient based care with inpatient and community care as required); (2) standard care with 2 years of add-on stage specific case-management (individualized care delivered by designated case managers according to specific protocol); and (3) standard care with 4 years of add-on stage specific case management.

The study hypothesis are: (1) both 2 years and 4 years of case management produce better outcomes than standard care alone; (2) 4 years of case management produces better outcome than 2 years of case management.

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
26 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis nos or delusional disorder
  • Cantonese-speaking Chinese
  • Ability to understand the nature of the study and sign informed consent
  • Capacity to participate in cognitive testing

排除标准

  • Organic Brain disorder
  • Known history of intellectual disability

结局指标

主要结局

Functioning (social and occupational)

时间窗: baseline, 6-month, 12-month, 24-month, 36-month, 48-month

次要结局

  • Depressive symptoms(baseline, 12-month, 24-month, 36-month, 48-month)
  • Neurocognitive functioning(baseline, 12-month, 24-month, 36-month, 48-month)
  • Health economics(baseline, 6-month, 12-month, 24-month, 36-month, 48-month)
  • Psychotic symptoms(baseline, 6-month, 12-month, 24-month, 36-month, 48-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Eric Y.H. Chen

Professor and Head of Department of Psychiatry

The University of Hong Kong

研究点 (1)

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