Cognitive Remediation of the Ability to Infer Intention of Others in Schizophrenic Patients - A Controlled, Randomized Trial (Phase IIb)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To demonstrate a measurable improvement of Theory of Mind based ability in schizophrenic patients induced by a novel cognitive therapy, as quantified by improvement of V-SIR scores (V-LIS scores in French literature).
研究概览
简要总结
Theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in patients with schizophrenia and its deficit to be correlated with their decreased social proficiency. We designed a novel cognitive therapy, that makes use of videos, aimed at learning a better use of contextual information to infer others' intentions. The aim of this study is to demonstrate, in schizophrenic patients, a quantitative improvement of their ability to infer intention of others induced by this novel training program. A secondary aim is to measure the cerebral correlates (MEG, PeV) of this social cognitive function and of its anticipated improvement.
详细描述
Scientific justification : Improvement by training has been demonstrated in Schizophrenic patients for various cognitive functions and skills, though not yet for the social cognition ability specifically dedicated to infer others' intention when not explicit.
Main hypothesis : Abilities to infer other's intention can improve in schizophrenic patients following specific practice.
Primary aim : To demonstrate this improvement, as quantified by improvement of V-SIR scores (V-LIS scores in French literature).
Procedure : Ten weekly sessions of a novel cognitive therapy that makes use of videos aimed at learning a better use of contextual information to infer others' intentions. Group of 5 patients trained by 2 therapists. Comparison with a non-cognitive psycho-educational training (same organisational design).
Study design : Controlled randomized simple blind study (equivalent to a Phase IIb therapeutic trial). Matched pair design. 40 patients (20 per arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 57 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia following DSM IV;
- •Age 18-57;
- •Stability of the clinical state;
- •Ability to learn;
- •Deficit in intention reading as measure with the V-SIR (V-LIS in French) test (score >13);
- •informed consent to participate to the study.
排除标准
- •Any other organic or neuropsychiatric disease
结局指标
主要结局
To demonstrate a measurable improvement of Theory of Mind based ability in schizophrenic patients induced by a novel cognitive therapy, as quantified by improvement of V-SIR scores (V-LIS scores in French literature).
时间窗: 6 MONTHS
次要结局
- To measure the extension of improvement to other cognitive functions - specific or non specific - and/or to every day life aptitudes(6 MONTHS)
- To evaluate correlations with functional measurements (e.g., magneto-encephalography, cognitive evoked potentials) [transversal study; longitudinal study].(6 MONTHS)