Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- STROOP
研究概览
简要总结
This study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.
详细描述
Evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder [ECo-Sz] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder.
In this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] to patients benefiting from recovery-oriented therapy [ThOR]. Patients are treated for two months and monitored for four months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Schizophrenia Disorder diagnosis, according to Diagnostic and Statistical Manual of mental disorders - Fifth edition (DSM-V) - Patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms)
- •Positive and Negative stable symptoms (no or few positive and negative symptoms)
- •Stable and effective minimum dose of medication (antipsychotic) for the last three months
- •Cognitive complaint expressed by the patient
- •Informed consent form read, initialed and signed
- •Understanding of spoken and read French
- •Patient registered on the social welfare system
排除标准
- •Other diagnosis at the forefront than Schizophrenia of the DSM-V
- •Medical history neurological disorder resulting in hospitalization
- •Acute episode in the last three month
- •Somatic disorders resulting in cognitive impairment
- •Engagement in a research protocol either currently or over the last month
- •Neuropsychological assessment evaluation during the last six month
- •Patients under the protection of a conservator (simple or reinforced)
- •Individuals in vulnerable circumstances
结局指标
主要结局
STROOP
时间窗: pre-inclusion
Interference score
TMTB
时间窗: pre-inclusion
Trail Making Test
Litteral score of Verbal fluences
时间窗: pre-inclusion
Litteral score of Verbal fluences
GO/NOGO
时间窗: pre-inclusion
cognitive control score
tower of Hanoi
时间窗: pre-inclusion
Tower planning total score from tower of Hanoi
Matrix test (WAIS-IV)
时间窗: pre-inclusion
The perceptual reasoning score of the Matrix test.
次要结局
- PANSS(pre-inclusion)
- ERF(Twenty six week)
- ERF-CS(Twenty six week)
- QFS(Twenty six week)
- Mini-500(pre-inclusion)
- CTQ(pre-inclusion)
- EESEP(Twenty six week)
- MCQ-30(Twenty six week)
- SAIQ(Twenty six week)
- SCS(Twenty six week)
- SDS(Twenty six week)
- STORI(Twenty six week)
研究者
Clémence ISAAC
Principal Investigator
Centre hospitalier de Ville-Evrard, France