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Cognitive Remediation in Schizophrenia

2014年12月4日 更新者:Gary Donohoe、University of Dublin, Trinity College

Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.

The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses.

Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

研究概览

详细说明

The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on

  1. Neuropsychological performance
  2. Brain Structure using voxel-based morphometry (VBM)
  3. Brain function using functional MRI (fMRI)
  4. Social and occupational functioning

The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.

研究类型

介入性

注册 (预期的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Dublin、爱尔兰、8
        • 招聘中
        • Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
        • 接触:
          • April H Hargreaves, PhD
          • 电话号码:35318962624
          • 邮箱:hargrea@tcd.ie
        • 接触:
        • 首席研究员:
          • Gary J Donohue, DClin Psych PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Schizophrenia
  • History of Psychosis
  • Subjective difficulties with memory or concentration
  • Aged 18-60 Years

Exclusion Criteria:

  • History of head injury resulting in loss of consciousness
  • Substance misuse in the last 3 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Cognitive Remediation Therapy
Participants will undertake approximately 30 minutes of computerized CRT training for 8 weeks, 5 days per week. They will meet a therapist once per week to discuss any difficulties, help motivation.
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
其他名称:
  • 阴极射线管
安慰剂比较:Placebo Comparator
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
Participant meets the therapist once per week but does not carry out the CRT intervention. (Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).
其他名称:
  • 无干预

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline neuropsychological performance
大体时间:Directly following study treatment period
A battery of neuropsychological tests will be used at baseline and the same tests used directly after the intervention to measure changes in attention and memory. Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
Directly following study treatment period

次要结果测量

结果测量
措施说明
大体时间
Change from baseline neuropsychological performance at 3 to 6 months post intervention
大体时间:3 to 6 months post study treatment period
A battery of neuropsychological tests will be used at baseline and the same tests used at 3 months post intervention to measure changes in attention and memory. Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.
3 to 6 months post study treatment period
Changes from baseline in brain activation during working memory testing
大体时间:Directly post study treatment period
Changes from baseline in brain activation during working memory testing will be measured using fMRI
Directly post study treatment period
Change from baseline in grey matter volume
大体时间:Directly following study treatment period
Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.
Directly following study treatment period

其他结果措施

结果测量
措施说明
大体时间
Changes in social and occupational functioning
大体时间:Directly following study treatment period
Social and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
Directly following study treatment period
Change from baseline in social and occupational functioning 3 to 6 months post intervention
大体时间:3 to 6 months post study treatment period
Social and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)
3 to 6 months post study treatment period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gary J Donoghoe, DClin Psych PhD、Trinity College Dublin, Ireland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年5月1日

初级完成 (预期的)

2015年6月1日

研究完成 (预期的)

2015年10月1日

研究注册日期

首次提交

2013年7月2日

首先提交符合 QC 标准的

2013年7月15日

首次发布 (估计)

2013年7月19日

研究记录更新

最后更新发布 (估计)

2014年12月5日

上次提交的符合 QC 标准的更新

2014年12月4日

最后验证

2014年12月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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