Preliminary Validation of the RC2S+ Therapy in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in the HB (Hostility Bias) score
研究概览
简要总结
Background:
Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.
New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.
The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.
详细描述
Methods:
This is a randomized controlled trial to establish the validity of the RC2S+ program in schizophrenia.
The project's main objective is to assess the impact of RC2S+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions.
The study has four other objectives:
- To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
- To assess the impact of the RC2S+ therapy versus control therapy on social functioning
- To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
- To study the maintenance of benefits 3 months forward
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years old
- •Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
- •No modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated
- •French native language or education in a French school since the first year of primary school
- •Consent to participate to the study and agreement of the legal guardian
- •Patients who have not benefited from cognitive remediation during the three months before inclusion
排除标准
- •Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
- •Neurologic disorders (vascular, infectious or neurodegenerative)
- •Uncorrected visual deficit
- •Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
- •Patients resistant to antipsychotic medication
- •Pregnancy
结局指标
主要结局
Change from baseline in the HB (Hostility Bias) score
时间窗: week 12
AIHQ (Ambiguous Intentions Hostility Questionnaire)
次要结局
- Change from baseline in social functioning(week 12)
- Change from baseline in symptoms at week 12(week 12)
- Change from baseline in episodic verbal learning and memory(week 12)
- Change from baseline in visual attention and task switching(week 12)
- Change from baseline in executive functioning at week 12(week 12)
- Change from baseline in social cognitive(week 12)
- Change from baseline in visuospatial abilities at week 12(week 12)