Clinical trial NCT06956794: Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Official title: Multimodal Training With Immersive VIRTUAL Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone (VirtualDONA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Isolation in Older Adults
Poverty
Keywords: Social Isolation
Cognitive Dysfunction
Aging
Poverty
Virtual Immersive Reality
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Broomx Technologies
name: SUARA Cooperativa
First posted: 2025-05-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two parallel groups: one receiving a multimodal group-based intervention using immersive virtual reality, and a control group maintaining usual activities. The intervention consists of 16 sessions over 8 weeks.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Female
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Differences between groups in scores of global cognition
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of global cognition
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of verbal episodic memory
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of auditory attention
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of working memory
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of processing speed
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of visual scanning and processing speed
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of executive functioning and cognitive flexibility
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of executive functioning
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of selective attention, inhibition, and processing speed
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of phonetic fluency
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of semantic verbal fluency
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in language
timeFrame: Baseline and after the 8-week intervention
Secondary outcomes:
measure: Differences between groups in scores of Quality of Life
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of loneliness
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of perceived social support
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of emotional well-being
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of depression
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of anxiety
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of frailty
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of dietary habits
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of performed physical activity
timeFrame: Baseline and after the 8-week intervention
measure: Differences between groups in scores of Sleep Quality
timeFrame: Baseline and after the 8-week intervention
Other outcomes:
measure: Qualitative user experience
timeFrame: Within one week after the end of the 8-week intervention
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: SUARA Cooperativa
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Maite Garolera, PhD
role: PRINCIPAL_INVESTIGATOR
References: