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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Poverty; Social Isolation in Older Adults
• Intervention / Treatment: Behavioral: VirtualDONA Multimodal Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08018
      • SUARA Cooperativa
    • Terrassa, Barcelona, Spain, 08227
      • Consorci Sanitari de Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual Activity (Control Group); Participants in this arm will continue their usual daily routines with no specific intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between groups in scores of global cognition	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.	Baseline and after the 8-week intervention
Differences between groups in scores of global cognition	Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.	Baseline and after the 8-week intervention
Differences between groups in scores of verbal episodic memory	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.	Baseline and after the 8-week intervention
Differences between groups in scores of auditory attention	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.	Baseline and after the 8-week intervention
Differences between groups in scores of working memory	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.	Baseline and after the 8-week intervention
Differences between groups in scores of processing speed	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.	Baseline and after the 8-week intervention
Differences between groups in scores of visual scanning and processing speed	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.	Baseline and after the 8-week intervention
Differences between groups in scores of executive functioning and cognitive flexibility	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.	Baseline and after the 8-week intervention
Differences between groups in scores of executive functioning	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.	Baseline and after the 8-week intervention
Differences between groups in scores of selective attention, inhibition, and processing speed	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.	Baseline and after the 8-week intervention
Differences between groups in scores of phonetic fluency	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.	Baseline and after the 8-week intervention
Differences between groups in scores of semantic verbal fluency	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.	Baseline and after the 8-week intervention
Differences between groups in language	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.	Baseline and after the 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between groups in scores of Quality of Life	Quality of Life is measured with EuroQoL-5D (EQ-5D) a self-completion questionnaire, which consists of five questions: covering mobility, hygiene, activities, pain, and anxiety. The descriptive system divides each of the 5 dimensions into three levels of response: the absence of a problem, some problem, and extreme problem. Lower scores indicate better outcomes. In addition, the questionnaire has a plus scale where the participants rated their health state on a scale of 0-100. In this scale, higher scores indicate better outcome.	Baseline and after the 8-week intervention
Differences between groups in scores of loneliness	Loneliness levels are measured through the UCLA Loneliness Scale, a widely recognized tool for measuring subjective feelings of loneliness or social isolation. The most recent version, contains 20 items rated on a scale from 1 (Never) to 4 (Always). Higher scores indicate worse outcomes.	Baseline and after the 8-week intervention
Differences between groups in scores of perceived social support	Perceived social support is measured with the Oslo 3-Item Social Support Scale (OSLO-3). The OSLO-3 is a brief measure of perceived social support, consisting of three items assessing the number of close confidants, perceived concern from others, and ease of obtaining practical help. Scores range from 3 to 14, with higher scores indicating greater perceived social support.	Baseline and after the 8-week intervention
Differences between groups in scores of emotional well-being	Emotional well-being is measured with the WHO-Five Wellbeing Index Scale (WHO-5). The WHO-5 is a brief self-reported measure of current mental well-being, consisting of five positively worded items. Each item is rated on a 6-point Likert scale, resulting in a raw score ranging from 0 to 25. The score is multiplied by 4 to yield a final score ranging from 0 to 100, where higher scores indicate better well-being.	Baseline and after the 8-week intervention
Differences between groups in scores of depression	Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome.	Baseline and after the 8-week intervention
Differences between groups in scores of anxiety	Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome.	Baseline and after the 8-week intervention
Differences between groups in scores of frailty	Frailty is measured with the FRAIL scale. The FRAIL Scale is a 5-item screening tool that assesses frailty based on fatigue, resistance, ambulation, illnesses, and loss of weight. Each item is scored as 0 (no) or 1 (yes), with total scores ranging from 0 to 5. Higher scores indicate greater levels of frailty.	Baseline and after the 8-week intervention
Differences between groups in scores of dietary habits	Dietary haabits are measured with the PREDIMED questionnaire (adherence to the Mediterranean diet). The PREDIMED is a 14-item questionnaire used to assess adherence to the Mediterranean diet. Each item is scored 0 or 1 depending on dietary habits, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet.	Baseline and after the 8-week intervention
Differences between groups in scores of performed physical activity	Performed physical activity is measured with The International Physical Activity Questionnaire (IPAQ) is a questionnaire composed of 7 questionsin order to assessthe frequency, duration, and intensity (vigorous or moderate) of the performed physical activity, walking, and sitting time during a business day for the last 7 days. Later, from the minutes obtained from the participant's answers, the METS (metabolic equivalent tasks) conversion is performed, allowing a classification, depending on the energy consumption obtained for each activity, into three categories (low, medium, high). Higher score indicate better outcome.	Baseline and after the 8-week intervention
Differences between groups in scores of Sleep Quality	Sleep Quality is measured with The Pittsburgh Sleep Quality Index (PSQI). This test presents 24 items, although only 19 are taken into account for the correction. This test is divided into 7 dimensions, namely, sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic drugs, and daytime dysfunction. Higher scores indicate worse sleep quality.	Baseline and after the 8-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative user experience	Post-intervention focus groups will explore participants' perceived cognitive and emotional benefits, program satisfaction, and usability of the immersive VR platform. Transcripts will be analyzed using thematic content analysis.	Within one week after the end of the 8-week intervention

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa
• Collaborators: Broomx Technologies; Suara Serveis SCCL
• Investigators: Principal Investigator: Maite Garolera, PhD, Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Cognitive Dysfunction; Poverty; Social Isolation; Virtual Immersive Reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Behavior; Social Behavior; Cognitive Dysfunction; Social Isolation
• Other Study ID Numbers: 2024PROD00053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No