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临床试验/NCT04251195
NCT04251195已完成不适用

Verbal Memory Training Using Virtual Reality in Schizophrenia

The Royal Ottawa Mental Health Centre2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Feasibility of the intervention

研究概览

简要总结

Verbal episodic memory is an independent declarative memory system associated with language and is responsible for storage and conscious recall of previous personal experiences. Verbal episodic memory is impaired in schizophrenia and is related to patients' functional outcomes. Because no medication has shown clear positive effects on verbal memory impairment in schizophrenia, there is a great need to find effective cognitive remediation treatments (CRT) that could improve this domain in this psychiatric population. Although CRT programs have shown small to moderate positive effects on verbal memory in individuals with schizophrenia, traditional lab-based computerised cognitive interventions have notable attrition rates. In recent years, along with the advancement of technology, the development of Virtual Reality (VR) has allowed the possibility for new training techniques. Previous studies have established the initial feasibility and safety of using VR in schizophrenia population. However, no studies have examined the feasibility, safety and efficacy of combining VR technology with verbal memory training among individuals with schizophrenia. Thus, in this study, we will adapt an exercise from the Strategy for Semantic Association Memory (SESAME; (Guimond et al., 2018; Guimond & Lepage, 2016) training to a VR environment. We aim to determine the feasibility of using virtual reality in the context of a cognitive remediation intervention and to assess the initial efficacy of our verbal memory training on the use of semantic encoding strategies in people with schizophrenia. We also aim to assess participants' experience and tolerability of the VR training.

详细描述

In this study, participants will first undergo the Hopkins Verbal Learning Test - Revisited (HVLT-R) to assess the baseline use of semantic clustering and verbal memory recall performance. Participants will then be randomly assigned to either a control group or a verbal training group. Participants in both groups will undergo a short session (15 minutes) of VR training. Finally, participants will be invited to perform an alternate version of the HVLT-R to assess initial change in semantic clustering and verbal memory recall performance after the training. They will also complete the VR Experience Questionnaire and the simulator sickness questionnaire (SSQ) in order for the research team to gain feedback from participants regarding their experience and tolerability of the VR session.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 20-60 years
  • the ability to read and speak fluent English
  • having a diagnosis of schizophrenia or schizoaffective from a psychiatrist and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) interview
  • considered clinically stable (on stable medication for more than one month, and have a score below 95 on the Positive and Negative Syndrome Scale (PANSS))

排除标准

  • having vision problems that cannot be corrected with contact lenses or glasses that fit into the VR goggles (because of requirements of VR headset)
  • having significant neurological or medical disorders (other than schizophrenia/schizoaffective disorder) that may produce cognitive impairment
  • a recent history of substance abuse or dependence (within the past 3 months)
  • decisional incapacity requiring a guardian
  • having past or current conditions of seizure, epilepsy, migraines or cybersickness

结局指标

主要结局

Feasibility of the intervention

时间窗: baseline, post treatment (~20 minutes)

Feasibility of the intervention as measured by the number of people who complete the intervention.

Change in semantic encoding strategy use as measured by change in semantic clustering from baseline - the Hopkins Verbal Learning Test - Revisited (HVLT-R).

时间窗: baseline, post treatment (~20 minutes)

The Hopkins Verbal Learning Test - Revisited (HVLT-R) for verbal memory is a 12-item test to measure a person's ability to encode, combine, store and recover verbal information in memory.

次要结局

  • Change in verbal memory performance from baseline(baseline, post treatment (~20 minutes))
  • Participants' experience and tolerability - VR experience questionnaire(post treatment (~20 minutes))
  • Participants' experience - Simulator sickness questionnaire (SSQ)(post treatment (~20 minutes))

研究者

发起方
The Royal Ottawa Mental Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Synthia Guimond

Scientist

The Royal Ottawa Mental Health Centre

研究点 (2)

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