Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- improvement in attention
研究概览
简要总结
A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate (≥5 years of formal education).
- •Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
- •Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening
- •No hospitalizations in the last 6 months.
排除标准
- •Other Axis I psychiatric disorders, substance abuse or dependence.
- •History of head trauma or other neurologic diseases.
- •Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,
- •Suicide risk
- •Participation in any other kind of psychosocial intervention.
研究组 & 干预措施
arithmetic training (Kumon method)
干预措施: cognitive training (Other)
nonspecific recreation
干预措施: placebo (Other)
结局指标
主要结局
improvement in attention
时间窗: change from baseline to 6 months and to 12 months
neuropsychological battery
improvement in working memory
时间窗: change from baseline to 6 months and to 12 months
neuropsychological battery
improvement in executive function
时间窗: change from baseline to 6 months and to 12 months
neuropsychological battery
次要结局
- psychopathology(change from baseline to 6 months and to 12 months)
- functioning(change from baseline to 6 months and to 12 months)
研究者
Mario R. Louza, MD, PhD
Principal Investigator
University of Sao Paulo