Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
2026年7月13日 更新者：Sofia Borges de Sousa、Grupo Lusófona
Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
The aim of this pilot RCT is the development, implementation, and evaluation of a cognitive stimulation program with virtual reality for individuals aged 65 or older who have depressive symptoms and attend Portuguese day centers.
The program aims to promote their cognitive functioning, well-being and functionality, and to reduce their depressive symptoms.
A pilot study of the program will be conducted to assess its feasibility and preliminary efficacy.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
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
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Individuals aged 65 years or older attending Portuguese day care centers;
- Presence of mild, moderate, or severe depressive symptomatology;
- Language skills and visual acuity.
Exclusion Criteria:
- Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive stimulation + VR
Participants receive a cognitive stimulation program with virtual reality.
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Twelve group sessions of a cognitive stimulation program with virtual reality.
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无干预：Wait-list Control
Participants assigned to the waitlist control condition remain on the waitlist throughout the study and are offered the intervention upon completion of the post-intervention assessment phase.
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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 |
|---|---|---|
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Adherence
大体时间：Throughout the intervention period (6 weeks)
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The proportion of participants who complete all intervention sessions.
Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.
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Throughout the intervention period (6 weeks)
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Acceptability and Feasibility
大体时间：Post-intervention (at week 7)
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Acceptability and feasibility will be assessed through Theoretical Framework of Acceptability Questionnaire (TFA).
All items are assessed on a 5-point Likert scale, with scores ranging from 1 to 5. Scores range from 7 to 35, with higher scores indicating better acceptability and feasibility.
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Post-intervention (at week 7)
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Acceptability and perceived barriers (semi-strutured interviews)
大体时间：Post-intervention (at week 7)
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Acceptability of the intervention will be assessed through semi-structured interviews conducted with each participant after the intervention.
The interviews will explore participants' overall evaluation of the program, including its perceived relevance, satisfaction with the intervention, and willingness to continue or recommend it.
Perceived barriers to implementation will also be explored by asking participants to describe any difficulties or challenges they experienced during their participation.
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Post-intervention (at week 7)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depressive symptoms
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in depressive symptoms will be assessed using the Geriatric Depression Scale (GDS-15), a 15-item questionnaire with yes/no responses, with total scores ranging from 0 to 15, where higher scores indicate greater depressive symptomatology.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Well-being
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
The scale consists of 14 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always), with total scores ranging from 14 to 70.
Higher scores indicate greater levels of well-being.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Functionality
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in functional ability will be assessed using the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale.
The scale consists of 8 items and total score ranges from 8 to 30 points, with 8 indicating independence, scores between 9 and 20 indicating moderate dependence and scores above 20 indicating severe dependence.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Global cognitive functioning
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in cognitive functioning will be assessed using the total score of the Neuropsychological Assessment Questionnaire that assesses multiple cognitive functions.
The total score ranges from 0 to 112 points, with higher total scores indicating better cognitive performance.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Visual attention and processing speed
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in visual attention and processing speed will be assessed using the Trail Making Test Part A (TMT-A).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer visual attention and processing speed.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Executive functioning and cognitive flexibility
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in executive functioning and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer executive functioning and cognitive flexibility.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Frontal executive functioning
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in executive functioning will be assessed using Frontal Assessment Battery (FAB), a brief screening tool composed of 6 subtests.
Total scores range from 0 to 18, with higher scores indicating better executive functioning.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Attention and immediate verbal memory
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in attention and immediate verbal memory will be assessed using the Digit Span Forward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences, with higher scores indicating better attention and immediate verbal memory.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Working memory
大体时间：Baseline, post-intervention (at week 7) and follow-up (3 months)
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Changes in working memory will be assessed using the Digit Span Backward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences in reverse order, with higher scores indicating better working memory performance.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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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。
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 (估计的)
2026年9月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年6月18日
首先提交符合 QC 标准的
2026年7月13日
首次发布 (实际的)
2026年7月17日
研究记录更新
最后更新发布 (实际的)
2026年7月17日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年7月1日
更多信息
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