PLANning Your Every Day Life I Virtual REality : a Study Schizophrenia. Mathurin Serious Game
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Efficacy of PLANI-REV : questionnaire scores
研究概览
简要总结
Patients with schizophrenia , who visit frenquently day-care or day-care activities clinics, often experience difficulties of daily living and cognitive deficits. Living independently is a key for recovery. Cognitive remediation is a therapy which reduces deficit and improves daily living. Nowadays no program exists targeting neurocognitive functions in virtual reality which could mimic everyday life in a virtual town.
Hypotheses :
- Persons with schizophrenia experience difficulties in daily living and disabilities to plan in everyday life. PLANI-REV program, a serious game with a navigation in a virtual town, in a 15 weekly group sessions could reduce these difficulties compared to the initial assessment. This improvement could be maintained 6 months after the end of the program.
- PLANI-REV could also improve prospective memory, attention, working memory, and visuospatial organization.
- PLANI-REV could induce a clinical improvement, as well as better perception of self-efficiency, self esteem, quality of life, and conversation skills.
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
- 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
- •Age between 18 and 50 years old.
- •Diagnostic of schizophrenia or schizoaffective disorder (DSM V), attested by the MINI structured interview (Shehan et al. 1998)
- •Who visit for months or year, weekly or several times per week, a day care, or therapeutic activity units outpatients clinics and nursing homes
- •French Mother tongue
- •Consent of the legal representative caregiver for the patients under representative law (tutelle in French).
- •Clinical Stability - Therapeutic stability for at least one month.
- •National healthcare assurance
排除标准
- •Central Neurological or non stabilized somatic diseases.
- •Treatments for somatic disease with putative psychotropic effect.
- •Electroconvulsive therapy in the last six months
- •Illetrism
- •IQ< 70 established with the f-NART.
- •Substance misuse or dependence (except Nicotine) or toxic for more than 5 years.
研究组 & 干预措施
PLANI-REV
Persons with schizophrenia who will benefit from the fifteen weekly sessions of PLANI-REV group program
干预措施: PLANI-REV (Other)
RELAXATION
Persons with schizophrenia who will benefit from a non cognitive stimulation, namely RELAXATION, in a day-care clinic or day-care therapeutic activities center during fifteen weekly sessions. This activity will be 15 groups sessions of relaxation.
干预措施: RELAXATION (Other)
结局指标
主要结局
Efficacy of PLANI-REV : questionnaire scores
时间窗: 10 months
the comparison pre/post PLANI-REV of the number of difficulties of daily life using the Profinteg questionnaire
次要结局
- - Profinteg scores 6 months after PLANI-REV. Number of problematic activities; average score for difficulties of problematic activities.(16 months)