Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06956794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Sponsor:
Consorci Sanitari de Terrassa
Organization:
Study Overview
Official Title:
Multimodal Training With Immersive VIRTUAL Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone (VirtualDONA)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VirtualDONA
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: