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.
Study 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.
Eligibility
Sex
FEMALE
Min age
65 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Differences between groups in scores of global cognition — 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 global cognition — Baseline and after the 8-week intervention 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.
Differences between groups in scores of verbal episodic memory — 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 — 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 — 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 — 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 — 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 and cognitive flexibility — 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 executive functioning — 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 — 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 — 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 — 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 — 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.
Trial sites (2)
Facility
City
Region
Status
SUARA Cooperativa
Barcelona
Barcelona
Consorci Sanitari de Terrassa
Terrassa
Barcelona
More Consorci Sanitari de Terrassa trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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