Efficacy of Hierarchized Computer-assisted Cognitive Remediation Therapy in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)
研究概览
简要总结
Objectives:
The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.
详细描述
Methods:
In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.
Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •schizophrenia (DSM IV criteria)
- •remitted symptoms
- •french language
- •informed consent
排除标准
- •addiction, neurological disease
- •only for second randomized patient participating in MRI study (n=30) : MRI counterindications
结局指标
主要结局
cognitive deficits (attention/concentration, topological memory, logical reasoning, executive functions)
时间窗: before and after CRT (3 months later)
standardised COGTEST battery (for details see cogtest.com). Cognitive performances were assessed 2 times : at inclusion and 3 months later (after CRT).
次要结局
- brain functioning (fMRI)(before and after CRT (3 months later))
- schizophrenia symptoms(before CRT and 3 months later)