Multimodal Training With Immersive VIRTUAL Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone (VirtualDONA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Differences between groups in scores of global cognition
研究概览
简要总结
This study aims to evaluate the effectiveness of an immersive virtual reality-based multimodal intervention (VirtualDONA) to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. The intervention combines mindfulness, cognitive, and physical training in a group format over 8 weeks.
详细描述
The VirtualDONA project aims to promote the health of older women living alone and at risk of poverty, as they are considered a highly vulnerable population. Women's longer life expectancy compared to men leads to a greater proportion of women living alone. In Catalonia, there are 786,000 people living alone, and 42.2% are aged 65 or older. The combination of being a woman, of advanced age, and living alone is associated with a high rate of poverty.
These social and economic determinants significantly increase the likelihood of developing dementia and/or mental health disorders in affected individuals. Research has established a connection between social isolation, aging, and a higher probability of experiencing dementia, stress, depression, and anxiety. Economic uncertainty is also known to contribute to stress and anxiety, while social stigma-particularly affecting older women-can negatively impact their cognitive and mental health.
All of these factors highlight the need for preventive interventions targeting women over the age of 65 who live alone and have incomes below the minimum income threshold. VirtualDONA proposes a preventive intervention for this population using immersive virtual reality technology (without headsets) to improve cognitive functioning, emotional well-being, and quality of life.
The intervention will be delivered in a group format over 8 weeks (16 sessions). The combination of mindfulness, cognitive, and physical exercises within a virtual environment offers a suitable multimodal platform for a comprehensive and innovative intervention aimed at vulnerable women. The project aims to demonstrate the benefits of this approach and to develop a sustainable, scalable, and long-term viable business model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Living alone
- •Registered with the elderly care services of Suara Cooperativa
- •Annual income below the guaranteed minimum income threshold (below €20,353.62/year)
- •Global cognitive functioning not suggestive of dementia, defined as MMSE score ≥ 24
- •Able to read and write
- •Good command of Catalan and/or Spanish
- •Signed informed consent to participate in the study
排除标准
- •History of severe neurological, psychiatric disorders, or intellectual disability
- •Uncorrected sensory deficits (e.g., vision or hearing)
- •Physical or motor impairments that may interfere with participation or bias outcome measures
研究组 & 干预措施
Immersive VR-Based Multimodal Intervention
Participants in this arm will receive a multimodal, group-based intervention using immersive virtual reality without headsets. The intervention includes mindfulness, cognitive training, and physical exercises delivered in 16 group sessions over 8 weeks.
干预措施: VirtualDONA Multimodal Program (Behavioral)
Usual Activity (Control Group)
Participants in this arm will continue their usual daily routines with no specific intervention during the study period.
结局指标
主要结局
Differences between groups in scores of global cognition
时间窗: Baseline and after the 8-week intervention
Global cognition is assessed with the Mini-Mental State Examination (MMSE), a brief screening tool for cognitive impairment. The MMSE includes items that evaluate orientation, registration, attention and calculation, recall, language, and visuospatial ability. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Differences between groups in scores of executive functioning and cognitive flexibility
时间窗: Baseline and after the 8-week intervention
Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.
Differences between groups in scores of verbal episodic memory
时间窗: Baseline and after the 8-week intervention
Verbal episodic memory is assessed with the Free and Cued Selective Reminding Test (FCSRT), which evaluates the ability to learn and recall words with both free and cued recall conditions. The total score ranges from 0 to 48, based on the number of words correctly recalled. Higher scores indicate better memory performance.
Differences between groups in scores of auditory attention
时间窗: Baseline and after the 8-week intervention
Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of working memory
时间窗: Baseline and after the 8-week intervention
Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of processing speed
时间窗: Baseline and after the 8-week intervention
Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.
Differences between groups in scores of visual scanning and processing speed
时间窗: Baseline and after the 8-week intervention
Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.
Differences between groups in scores of executive functioning
时间窗: Baseline and after the 8-week intervention
Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors indicate worse performance, while more categories completed reflect better executive functioning.
Differences between groups in scores of selective attention, inhibition, and processing speed
时间窗: Baseline and after the 8-week intervention
Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
Differences between groups in scores of phonetic fluency
时间窗: Baseline and after the 8-week intervention
Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.
Differences between groups in scores of semantic verbal fluency
时间窗: Baseline and after the 8-week intervention
Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.
Differences between groups in language
时间窗: Baseline and after the 8-week intervention
Language function is assessed using the 15-item version of the Boston Naming Test (BNT), a confrontation naming task consisting of 15 black-and-white line drawings of objects with increasing difficulty. The total score is the number of correctly named items. Higher scores indicate better naming ability.
次要结局
- Differences between groups in scores of anxiety(Baseline and after the 8-week intervention)
- Differences between groups in scores of frailty(Baseline and after the 8-week intervention)
- Differences between groups in scores of Quality of Life(Baseline and after the 8-week intervention)
- Differences between groups in scores of loneliness(Baseline and after the 8-week intervention)
- Differences between groups in scores of perceived social support(Baseline and after the 8-week intervention)
- Differences between groups in scores of emotional well-being(Baseline and after the 8-week intervention)
- Differences between groups in scores of depression(Baseline and after the 8-week intervention)
- Differences between groups in scores of dietary habits(Baseline and after the 8-week intervention)
- Differences between groups in scores of performed physical activity(Baseline and after the 8-week intervention)
- Differences between groups in scores of Sleep Quality(Baseline and after the 8-week intervention)
研究者
Maite Garolera
Chief of the Neuropsychological Unit and Director of the Brain, Cognition, and Behavior Research Group
Consorci Sanitari de Terrassa