Remediation of Working Memory in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Cognitive Assessment - MATRICS Consensus Cognitive Battery
研究概览
简要总结
The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.
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
- Double (Participant, 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
- 否
入选标准
- •Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- •No hospitalizations in the previous 4 weeks
- •No antipsychotic medication changes in the previous 4 weeks
- •Age 18-60
- •Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month
排除标准
- •History of clinically significant head injury or neurological disease
- •Poor comprehension of the English language
- •History of diagnosis of mental retardation or pervasive developmental disorder
- •Unable to give informed consent
结局指标
主要结局
Cognitive Assessment - MATRICS Consensus Cognitive Battery
时间窗: Post-intervention, within 2 weeks of completion of the 4 month intervention
The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.
次要结局
- Functional Capacity - University of California, San Diego Performance-Based Skills Assessment(Post-intervention, within 2 weeks of completion of the 4 month intervention)