Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline neuropsychological performance
研究概览
简要总结
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.
详细描述
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
- Neuropsychological performance
- Brain Structure using voxel-based morphometry (VBM)
- Brain function using functional MRI (fMRI)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schizophrenia
- •History of Psychosis
- •Subjective difficulties with memory or concentration
- •Aged 18-60 Years
排除标准
- •History of head injury resulting in loss of consciousness
- •Substance misuse in the last 3 months
研究组 & 干预措施
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.
干预措施: Cognitive Remediation Therapy (Other)
Placebo Comparator
Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.
干预措施: Placebo comparator (Other)
结局指标
主要结局
Change from baseline neuropsychological performance
时间窗: 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.
次要结局
- Change from baseline neuropsychological performance at 3 to 6 months post intervention(3 to 6 months post study treatment period)
- Changes from baseline in brain activation during working memory testing(Directly post study treatment period)
- Change from baseline in grey matter volume(Directly following study treatment period)
研究者
Gary Donohoe
Associate Professor
University of Dublin, Trinity College