Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
Virtual reality-based rehabilitation has recently gained increasing attention in the field of cognitive rehabilitation, allowing patients to engage in simulated real-life scenarios within a safe and controlled setting. The feasibility and safety of immersive VR-based cognitive rehabilitation in individuals with schizophrenia is currently insufficiently explored. This study seeks to evaluate whether immersive immersive virtual reality-based rehabilitation can be safely and practically implemented in a community psychiatric setting. The study also aims to explore preliminary effects on negative symptoms, cognitive performance, and global functioning compared with treatment as usual in a waiting-list control group.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with Schizophrenia/Schizoaffective Disorder (DSM-5-TR)
- •Age 18-67 years
- •Chronic phase of illness
- •Able to provide a valid informed consent
排除标准
- •Recent substance use (less than six months)
- •Concomitant intellectual disability or neurological disorders (e.g., neurodegenerative disorders, Parkison's disease, brain cancer) that may impair the ability to undergo cognitive rehabilitation
- •With a recent (less than six weeks from the enrolling date) symptom exacerbation, hospitalization or change in pharmacotherapy
- •Acute phase of illness
研究组 & 干预措施
Immersive Virtual Reality-Based Cognitive Rehabilitation
patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU)
干预措施: CEREBRUM VR (Device)
Waiting List
The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU
干预措施: Waiting List (Other)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: From enrollment to the end of treatment at 12 weeks
Total score, positive and negative symptoms, general psychopathology
次要结局
- Global Assessment of Functioning (GAF)(From enrollment to the end of treatment at 12 weeks)
- Digital Symbol Substitution Test (DSST)(From enrollment to the end of treatment at 12 weeks)
- Animal Naming Test (ANT)(From enrollment to the end of treatment at 12 weeks)
- Trial Making Test - A (TMT)(From enrollment to the end of treatment at 12 weeks)
- Simple Reaction Time (SRT)(From enrollment to the end of treatment at 12 weeks)
- Choice Reaction Time (CRT)(From enrollment to the end of treatment at 12 weeks)