VIVA-CORE! Virtual Reality VAlidation Tool for Cognitive Rehabilitation, a REcovery Oriented Project for People With Psychosocial Disabilieties: Protocol of Randomize Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Attention
研究概览
简要总结
Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A and then to the group B.
详细描述
Background: Cognitive remedial interventions have been found to be effective in the treatment of various psycho-social disorders. The use of Virtual reality as a rehabilitation tool has been showing various scientific evidences in recent years like in cardiovascular, neurological and musculoskeletal rehabilitation. In mental health evidence they seem to be concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis and psychotherapy. The aim of this study is to evaluate the feasibility and the effectiveness of the first Cognitive Remedial toll in Virtual Reality (CEREBRUM) for people that has experienced in mental health.
Methods: Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a intervention of 3 months with 2 weekly session of CEREBRUM first to the group A and then to the group B
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
people with psychosocial disabilities
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75;
- •Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
- •both sexes;
- •users who sign the informed consent;
- •users under protection for which the informed consent is signed by the guardian
排除标准
- •The non-satisfaction of the inclusion criteria;
- •The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality
研究组 & 干预措施
virtual reality
The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
干预措施: Cognitive remedy intervention with virtual reality (CEREBRUM) (Device)
waiting list
waiting list
干预措施: Cognitive remedy intervention with virtual reality (CEREBRUM) (Device)
结局指标
主要结局
Attention
时间窗: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Matrix Test Digit Symbol Substitution Test
Memory
时间窗: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
Monitoring Side effects of Virtual Reality
时间窗: During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Questionnaire (Qualitative)
Executive functions
时间窗: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB
次要结局
- Quality of Life(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
- Alexithymia(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
- Biological Rythms(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
- Anxiety(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
- General and social functioning(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
- Depression(All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline))
研究者
Mauro Giovanni Carta
Professor
University of Cagliari