Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Movie to Assess Social Cognition (MASC)
研究概览
简要总结
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition".
"Social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life.
People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration.
The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of schizophrenia, schizo-affective disorder (DSM-V criteria; APA, 2013).
- •French mother tongue.
- •psychotropic treatment unchanged during the month prior to inclusion.
- •Patients who gave their informed consent to participate in the study.
- •affiliated with a social security scheme or beneficiary of such a scheme
- •Subject suitable for the practice of sport.
排除标准
- •Recent dependence and abuse on cannabis or any other substance (DSM-V criteria), except tobacco.
- •Neurological disorders of vascular, infectious or neurodegenerative origin.
- •taking of medicinal products with a cerebral or psychic impact (e.g., corticosteroids).
- •Inability to practice sport
- •Pregnancy planned or in progress
- •Simultaneous Participation in any other program of remediation of social cognition, training in social skills, self-esteem.
研究组 & 干预措施
TAU + TOUCH RUGBY
TAU + Touch Rugby Program
干预措施: TOUCH RUGBY PROGRAM (Other)
REMEDRUGBY
TAU + RemedRugby Program
干预措施: REMEDRUGBY PROGRAM (Other)
TAU + TOUCH RUGBY
TAU + Touch Rugby Program
干预措施: TAU (Other)
REMEDRUGBY
TAU + RemedRugby Program
干预措施: TAU (Other)
结局指标
主要结局
Movie to Assess Social Cognition (MASC)
时间窗: Changes between baseline function, after intervention and at 6 months of follow-up
Changes in the aggregates (average) of standardized performance levels : z-scores of Theory of Mind (range 0-45) during social cognitive remediation
次要结局
- Positive and Negative Symptoms Scale for Schizophrenia (PANSS)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Personal and Social Performance scale (PSP)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Boston University Empowerment Scale (BUES)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Social Perception and Knowledge (PerSo)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Trail Making Test B (TMT B)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Self Esteem Rating Scale (SERS)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Trail Making Test A (TMT A)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Self-assessment of Social Cognition (AcSo)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Ambiguous Intentions and Hostility Questionnaire (AIHQ)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Stages of Recovery Instrument (STORI)(Changes between baseline function, after intervention and at 6 months of follow-up)
- French National Adult Reading Test (f-NART(Baseline measure only)
- Commission Test (modified zoo test)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Internalized Stigma of Mental Illness (ISMI)(Changes between baseline function, after intervention and at 6 months of follow-up)
- Questionnaire of Cognitive and Affective Empathy(Changes between baseline function, after intervention and at 6 months of follow-up)
研究者
Dr Julien Dubreucq
Medical Doctor
Hospital Center Alpes-Isère