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临床试验/NCT04291586
NCT04291586已完成不适用

The Impact of Using an Interactive System and a Paper and Pencil Program in Psychosocial Rehabilitation of Psychiatric Patients

Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年6月3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
29
试验地点
2
主要终点
Montreal Cognitive Assessment (Cognitive Screening)

研究概览

简要总结

Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context.

The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.

详细描述

Cognitive impairments are frequently present on many psychiatric diseases, such as schizophrenia, depression, etc. and are not always given sufficient attention despite its limitations in activities of daily living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday life, and have limited ecological validity.

Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems but, does it have more impact than a paper and pencil personalized intervention?

Through a participatory design approach, with health professionals, the investigators have developed:

a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and; a web tool which generates personalized paper and pencil tasks (Task Generator).

The investigators goal is to have a sample of 30 inpatients from a psychosocial rehabilitation unit, with no age limit, randomly allocated in two groups: 1) the experimental group, where participants will perform 30 minutes of the VR training with Reh@City; and 2) the control group, where participants will perform 30 minutes of the paper and pencil training with the Task Generator.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Inpatients of psychosocial rehabilitation unit;
  • Cognitive deficit but with enough capacity to understand the task and follow instructions;
  • Able to read and write.

排除标准

  • Patients experiencing an acute psychiatric episode.

结局指标

主要结局

Montreal Cognitive Assessment (Cognitive Screening)

时间窗: Baseline, End (8 weeks) and 8-weeks follow-up

Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes.

次要结局

  • Symbol Search and Coding (WAIS III)(Baseline, End (8 weeks) and 8-weeks follow-up)
  • Rey 15-Item Memory Test(Baseline, End (8 weeks) and 8-weeks follow-up)
  • Toulouse-Pieron (Attention)(Baseline, End (8 weeks) and 8-weeks follow-up)
  • Semantic Fluency and Phonemic Fluency Tests(Baseline, End (8 weeks) and 8-weeks follow-up)
  • Rey Complex Figure(Baseline, End (8 weeks) and 8-weeks follow-up)
  • Verbal Paired Associates (WMS-III) (Memory)(Baseline, End (8 weeks) and 8-weeks follow-up)

研究者

发起方
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
申办方类型
Other
责任方
Sponsor

研究点 (2)

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