Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone

NCT ID: NCT06956794

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2026-06-01

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.

Conditions

Social Isolation in Older Adults; Poverty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VirtualDONA Multimodal Program

Intervention Type: BEHAVIORAL

A group-based behavioral intervention using immersive virtual reality without headsets. The 8-week program includes 16 sessions combining mindfulness, cognitive training, and physical exercises, designed to improve cognitive health and emotional well-being in older women living alone and at risk of poverty.

Usual Activity (Control Group)

Participants in this arm will continue their usual daily routines with no specific intervention during the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VirtualDONA Multimodal Program

A group-based behavioral intervention using immersive virtual reality without headsets. The 8-week program includes 16 sessions combining mindfulness, cognitive training, and physical exercises, designed to improve cognitive health and emotional well-being in older women living alone and at risk of poverty.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Broomx Technologies

UNKNOWN

Sponsor Role: collaborator

SUARA Cooperativa

UNKNOWN

Sponsor Role: collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Maite Garolera

Chief of the Neuropsychological Unit and Director of the Brain, Cognition, and Behavior Research Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maite Garolera, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Locations

SUARA Cooperativa

Barcelona, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Countries

Spain

Other Identifiers

2024PROD00053

Identifier Type: -

Identifier Source: org_study_id