Cognitive Remediation in Early Phase Psychosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- MATRICS Consensus Cognitive Battery (MCCB)
研究概览
简要总结
The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early phase schizophrenia, schizoaffective disorder, psychosis NOS
- •Less than 5 years since start of adequate treatment for psychotic disorder
- •Age between 18-40
- •Norwegian speaking (sufficiently to understand and complete assessments)
排除标准
- •Traumatic brain injury
- •Neurological disorder as determined by medical history
- •IQ below 70
结局指标
主要结局
MATRICS Consensus Cognitive Battery (MCCB)
时间窗: Change in MCCB performance from baseline to 4 months and 9 months
Included in the MCCB are measures of the following cognitive domains: Speed of Processing, Attention, Working memory, Verbal learning, Visual Learning, Reasoning and problem solving and Social Cognition. In addition the following tests are included: HVLT-R and BVMT-R delayed recall to measure memory, TMTB (Halstead Reitan) and Color Word Inteference Test (D-KEFS) to measure executive functioning), Digit span (WAIS-III)to measure working memory, Grooved Pegboard (Halstead Reitan) to measure motor function.
UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
时间窗: Change in UPSA-B performance from baseline to 4 months and 9 months
Cognitive Assessment Interview (CAI)
时间窗: Change in CAI scores from baseline to 4 months and 9 months
Social Functioning Scale (SFS)
时间窗: Change in SFS scores from baseline to 4 months and 9 months
次要结局
- Calgary Depression Scale(Change in CDS scores from baseline to 4 months and 9 months)
- Global Assessment of Function (GAF)- split version(Change in GAF scores from baseline to 4 months and 9 months)
- event related fMRI(Change in BOLD fMRI signal from baseline to 4 months)
- Rosenberg Self-Esteem Scale (RSES)(Change in RSES scores from baseline to 4 months and 9 months)