Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
NCT06956794, Not applicable, Active not recruiting, Consorci Sanitari de Terrassa
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone | ClinicalTrials.gov |
| NCT number | NCT06956794 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Consorci Sanitari de Terrassa | ClinicalTrials.gov |
| Conditions | Social Isolation in Older Adults, Poverty | ClinicalTrials.gov |
| Interventions | VirtualDONA Multimodal Program | ClinicalTrials.gov |
| First posted | 2025-05-04 | ClinicalTrials.gov |
| Last updated | 2026-10-21 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of Quality of Life | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of loneliness | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of perceived social support | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of emotional well-being | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of depression | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of anxiety | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
| Secondary | Differences between groups in scores of frailty | Baseline and after the 8-week intervention | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 10
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)