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Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

2026年6月2日 更新者：Gabriele Nibbio、Università degli Studi di Brescia

FULL-MINDSET- Fully Immersive Virtual Reality-based Cognitive Training in Schizophrenia and Bipolar Disorder: a Single Blind Randomized Controlled Trial in a Real-world Setting

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality-based cognitive remediation (VRCR) intervention in improving cognitive performance and psychosocial functioning in individuals with schizophrenia spectrum disorders (SSD) and bipolar disorder (BD).

A total of 80 participants (40 with SSD and 40 with BD) will be randomly assigned in a 1:1 ratio to receive either VRCR or treatment as usual (TAU). The VRCR intervention will be delivered using the CEREBRUM platform and will consist of 45-minute sessions administered twice weekly for 12 weeks under the supervision of trained therapists.

The primary outcomes are changes in cognitive performance and psychosocial functioning, assessed using the MATRICS Consensus Cognitive Battery (MCCB) and the Personal and Social Performance (PSP) scale, respectively. Secondary outcomes include clinical symptom severity, assessed with validated rating scales, and neurobiological correlates, including functional magnetic resonance imaging (fMRI) and genetic biomarkers.

Assessments will be conducted at baseline, at 3 months (post-intervention), and at 6 months (follow-up). fMRI assessments will be conducted at baseline in patients with schizophrenia spectrum disorders, whereas peripheral blood samples for genetic marker analyses will be collected at baseline and at the 3-month follow-up in patients with SSD and BD. This study is expected to provide evidence on the feasibility, acceptability, and effectiveness of VR-based cognitive remediation in SSD and BD, as well as insights into the neurobiological mechanisms underlying cognitive and functional improvements.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • Lombardy
      • Brescia、Lombardy、意大利、25123
        • ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of schizophrenia spectrum disorder or bipolar disorder (DSM-5)
  • Clinical stability for at least 3 months
  • Ability to provide informed consent

Exclusion Criteria:

  • neurological disorders
  • intellectual disability
  • inability to participate in VR-based interventions due to medical or sensory limitations.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Participants with diagnosis of schizophrenia receiving VRCR
行为的：Virtual Reality Cognitive Remediation (VRCR)

Participants in the VRCR group will receive individualized cognitive training using the CEREBRUM platform (IDEGO, Rome, Italy).

CEREBRUM is an immersive virtual reality software where the user wearing the viewer sees a virtual environment that can be explored at 360°; it consists of 52 ecologically valid exercises of varying difficulty: 22 belonging to the Memory, and Learning Module, 10 to the Cognitive Estimates Module and 20 to the Attention and Working Memory Module. The difficulty of exercises is adaptable to provide adequately implement scaffolding and errorless learning principles, and the exercises require active interaction with the therapist. The software is compatible with the Oculus Go virtual reality viewer, a device with CE obligation. The program consists of 12 weeks of individual training, delivered twice weekly in 45-minute sessions in a controlled setting, from T0 (baseline) to T1 (3 months after T0).
有源比较器：Participants with diagnosis of schizophrenia receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
其他：Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
实验性的：Participants with diagnosis of bipolar disorder receiving VRCR
行为的：Virtual Reality Cognitive Remediation (VRCR)

Participants in the VRCR group will receive individualized cognitive training using the CEREBRUM platform (IDEGO, Rome, Italy).

CEREBRUM is an immersive virtual reality software where the user wearing the viewer sees a virtual environment that can be explored at 360°; it consists of 52 ecologically valid exercises of varying difficulty: 22 belonging to the Memory, and Learning Module, 10 to the Cognitive Estimates Module and 20 to the Attention and Working Memory Module. The difficulty of exercises is adaptable to provide adequately implement scaffolding and errorless learning principles, and the exercises require active interaction with the therapist. The software is compatible with the Oculus Go virtual reality viewer, a device with CE obligation. The program consists of 12 weeks of individual training, delivered twice weekly in 45-minute sessions in a controlled setting, from T0 (baseline) to T1 (3 months after T0).
有源比较器：Participants with diagnosis of bipolar disorder receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
其他：Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Cognitive performance will be assessed using the MATRICS Consensus Cognitive Battery (MCCB), a standardized neuropsychological battery evaluating processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, and social cognition.
Baseline, 3 months (end of the intervention), and 6 months
Change in psychosocial functioning measured by Personal and Social Performance (PSP) scale
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Psychosocial functioning will be assessed using the Personal and Social Performance (PSP) scale, which evaluates socially useful activities, personal and social relationships, self-care, and disturbing or aggressive behaviors.
Baseline, 3 months (end of the intervention), and 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Clinical Global Impression (CGI) severity score
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Baseline, 3 months (end of the intervention), and 6 months
Change in Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia spectrum disorders
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Baseline, 3 months (end of the intervention), and 6 months
Change in Brief Negative Symptom Scale (BNSS) total score in participants with schizophrenia spectrum disorders
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Baseline, 3 months (end of the intervention), and 6 months
Change in Hamilton Depression Rating Scale (HAM-D) total score in participants with bipolar disorder
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Baseline, 3 months (end of the intervention), and 6 months
Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder
大体时间：Baseline, 3 months (end of the intervention), and 6 months
Baseline, 3 months (end of the intervention), and 6 months
Neurobiological correlates assessed by functional magnetic resonance imaging (fMRI) in patients with a diagnosis of SSD
大体时间：Baseline
Baseline
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
大体时间：Baseline to 3 months (end of the intervention)
Blood samples will be analyzed to assess biomarkers associated with neuroplasticity and cognitive functioning in patients with SSD and BD.
Baseline to 3 months (end of the intervention)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Università degli Studi di Brescia

调查人员

  • 学习椅：Antonio Vita, MD, PhD、Università degli Studi di Brescia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月1日

初级完成 (估计的)

2026年6月1日

研究完成 (估计的)

2026年6月1日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2025年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • FULL-MINDSET

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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