Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change from baseline in Scale of Assessment of Negative Symptoms
研究概览
简要总结
Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.
详细描述
This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.
160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 50 years old
- •Diagnosis of schizophrenia according to the DSM-IV-TR
- •French speaker
- •Unchanged psychotropic treatment during month preceding the inclusion
- •Patients having given their consent lit to participate in the study
- •Patients not having been part of therapeutic education program during six months preceding the inclusion
- •Affiliated to the French social security
排除标准
- •Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco
- •History of neurobiological illness or trauma
- •Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)
- •Simultaneous participation on another program of cognitive remediation
- •The ineffectiveness of neuroleptic treatment
研究组 & 干预措施
Social Cognition and Interaction Training (SCIT)
SCIT Social cognition and interaction training program.
干预措施: Social Cognition and Interaction Training (SCIT) (Behavioral)
Therapeutic education program (ETP)
Therapeutic education program
干预措施: therapeutic education program (ETP) (Behavioral)
结局指标
主要结局
Change from baseline in Scale of Assessment of Negative Symptoms
时间窗: 40 weeks
Improvement of negative symptoms of schizophrenia in patients who received Social Cognition and Interaction Training (SCIT) program compared to patients receiving a Therapeutic Education Program (ETP), equivalent in number, duration and rhythm of sessions
次要结局
- Change from baseline in positive and negative symptoms scale (PANSS)(40 weeks)