NCT05784948已完成不适用
Efficacy of Virtual Reality Mindfulness in Patients With Psychosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Efficacy Assessment by Experience Questionnaire Decentering
研究概览
简要总结
This study is to evaluate the safety and efficacy of Virtual Reality Mindfulness in Patients With Psychosis.
详细描述
This study is randomized, single-blind and parallel group trial to evaluate the safety and the efficacy of Virtual Reality Mindfulness in Patients With Psychosis once a week over 8 weeks treatment period. Both groups can experience the screen coming out of the head-mounted display for 30 minutes in a comfortable sitting position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients who are 15-59 years (inclusive) of age at time of consent.
- •Patients with current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-fifth edition) diagnosis schizophrenia spectrum and other psychotic disorders including bipolar and related disorders or depressive disorder with psychotic symptoms.
- •Patients who can agree to participate in the study in a stable state (Clinical Global Impression score of 5 or less) and cooperate appropriately with questionnaires and tests.
- •Patients with a SOFAS score in the range of 41 to 80 points.
- •Patients with a PANSS score of less than 85 points.
排除标准
- •Patients who are currently in poor health due to serious physical illness
- •Patients who are currently pregnant or lactating.
- •Patients who are accompanying intellectual disability with an Intelligence Quotient (IQ) of 70 or lower
- •Patients who have difficulty in agreeing to and participating in research due to severely impaired ability to verify reality
- •Patients with a PANSS score of 85 or higher or a CGI of 6 or higher
- •Patients with a SOFAS score of 40 or less or 81 or more
- •Patients who are currently in hospitalized
结局指标
主要结局
Efficacy Assessment by Experience Questionnaire Decentering
时间窗: 1 week
The experience questionnaire (EQ) is a psychological measure used to assess attentional bias. The questionnaire consists of 15 items, with a minimum score of 1 and a maximum score of 7. The higher scores indicate the better outcome.
次要结局
- Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I)(through study completion, an average of 8 weeks)
- Efficacy Assessment by Columbia-Suicide Severity Rating Scale(1 week)
- Efficacy Assessment by Health of the Nation Outcome Scales(1 week)
- Safety Assessment by Skin conductance level(1 week)
- Safety Assessment by Heart rate(1 week)
- Efficacy Assessment by self rating scale Perceived Stress Scale (PSS)(1 week)
- Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II)(through study completion, an average of 8 weeks)
- Efficacy Assessment by Social and Occupational Functioning Assessment Scale(1 week)
- Safety Assessment by R-R interval(1 week)
- Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K)(1 week)
- Efficacy Assessment by Positive and Negative Syndrome Scale(1 week)
- Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR)(1 week)
- Efficacy Assessment by self rating scale Beck Depression Inventory (BDI)(1 week)
- Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)(1 week)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital
研究点 (2)
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