Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Negative symptoms
研究概览
简要总结
A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group.
The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding of allocation will be maintained for the research workers until all outcome measures for all participants have been collected. Blindness will be maintained using a range of measures (e.g. separate offices for therapist and researchers, protocols for answering phones and emails and security for electronic randomization information). The trial statistician will be also blind to the randomization outcome.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria.
- •Age between 18 to 65 years-old.
- •Outpatient setting,
- •Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization.
- •No concomitant active substance abuse disorder, excluding nicotine.
- •Subjects are capable of providing informed consent.
排除标准
- •Previous diagnosis of learning disability according either to ICD- 10 or clinical history
- •Verbal expression difficulties, determined by language or medical causes.
- •Deafness and/or blindness.
- •Other physical handicaps to use VR devices.
- •Predominant positive symptoms, defined as PANNS-C >
- •Catatonic symptoms.
- •Previous epilepsy diagnosis.
- •Neurodegenerative disease.
结局指标
主要结局
Negative symptoms
时间窗: 12 weeks
The primary outcome will be the difference in the rate of change in negative symptoms at 3 months of follow-up. Negative symptoms are measured with the Positive and negative syndrome scale (PANSS) negative subscale. Scale's scoring system ranges from 7 to 49 points. A 25% reduction from the baseline score on the PANSS-N will be considered a significant decrease.
次要结局
- Positive symptoms(12 weeks)
- Mood symptoms(12 weeks)
- Quality of life: Short Form (36) Health Survey(12 weeks)
- Global functioning(12 weeks)
- Social anxiety(12 weeks)
- Adverse effects(12 weeks)
研究者
Javiera Libuy Mena
Director
Hospital de la Florida Dra. Eloiza Diaz