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临床试验/NCT00295048
NCT00295048已完成不适用

Cognitive Remediation for Schizophrenia

University of Maryland, Baltimore6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年11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
50
试验地点
6
主要终点
broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.

详细描述

Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. The personal, social and economic costs of this illness are enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (Bellack, Gold & Buchanan; 1999; Green, 1996). While standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation.

The purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty individuals with schizophrenia and related disorders will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR will be more effective than the control treatment in each domain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria
  • Age 18 through 50
  • Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff
  • Primary psychiatric medication is a new generation antipsychotic other than Clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment.

排除标准

  • Documented history of organic brain disease
  • Documented history of mental retardation
  • Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises
  • Diagnosis of current Substance Dependence according to DSM-IV criteria
  • Participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).

结局指标

主要结局

broad cognitive performance (as indexed by a composite of the neuropsychological measures) and on a composite of everyday problem solving

次要结局

  • individual cognitive domains and individual everyday problem solving domains, the interaction of treatment with various other variables

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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