Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Executive Function
研究概览
简要总结
The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder
- •More than 2 years illness duration
- •Mini Mental Status Examination score over 24
- •Global Assessment of Functioning scores between 40 and 70
排除标准
- •Current acute illness exacerbation
- •Mental Retardation
- •Neurological disorder which impairs cognition
- •Currently participating in social skills training or cognitive remediation
- •Change of antipsychotic medication one month before the trial or during the 40 study weeks
- •Diagnosis of alcohol or drug dependence within 6 months of trial commencement.
结局指标
主要结局
Executive Function
时间窗: Change from baseline in executive functioning at 40 weeks
Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.
次要结局
- Psychosocial Functioning(Change from baseline in social functioning scales at 40 weeks)
- Psychiatric Symptoms(Change from baseline in psychiatric symptoms scales at 40 weeks)
研究者
Aida Farreny
Dr. Aida Farreny
Fundació Sant Joan de Déu