Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
13 juli 2026 bijgewerkt door: Sofia Borges de Sousa, Grupo Lusófona
Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
The aim of this pilot RCT is the development, implementation, and evaluation of a cognitive stimulation program with virtual reality for individuals aged 65 or older who have depressive symptoms and attend Portuguese day centers.
The program aims to promote their cognitive functioning, well-being and functionality, and to reduce their depressive symptoms.
A pilot study of the program will be conducted to assess its feasibility and preliminary efficacy.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Individuals aged 65 years or older attending Portuguese day care centers;
- Presence of mild, moderate, or severe depressive symptomatology;
- Language skills and visual acuity.
Exclusion Criteria:
- Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cognitive stimulation + VR
Participants receive a cognitive stimulation program with virtual reality.
|
Twelve group sessions of a cognitive stimulation program with virtual reality.
|
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Geen tussenkomst: Wait-list Control
Participants assigned to the waitlist control condition remain on the waitlist throughout the study and are offered the intervention upon completion of the post-intervention assessment phase.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adherence
Tijdsspanne: Throughout the intervention period (6 weeks)
|
The proportion of participants who complete all intervention sessions.
Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.
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Throughout the intervention period (6 weeks)
|
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Acceptability and Feasibility
Tijdsspanne: Post-intervention (at week 7)
|
Acceptability and feasibility will be assessed through Theoretical Framework of Acceptability Questionnaire (TFA).
All items are assessed on a 5-point Likert scale, with scores ranging from 1 to 5. Scores range from 7 to 35, with higher scores indicating better acceptability and feasibility.
|
Post-intervention (at week 7)
|
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Acceptability and perceived barriers (semi-strutured interviews)
Tijdsspanne: Post-intervention (at week 7)
|
Acceptability of the intervention will be assessed through semi-structured interviews conducted with each participant after the intervention.
The interviews will explore participants' overall evaluation of the program, including its perceived relevance, satisfaction with the intervention, and willingness to continue or recommend it.
Perceived barriers to implementation will also be explored by asking participants to describe any difficulties or challenges they experienced during their participation.
|
Post-intervention (at week 7)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Depressive symptoms
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in depressive symptoms will be assessed using the Geriatric Depression Scale (GDS-15), a 15-item questionnaire with yes/no responses, with total scores ranging from 0 to 15, where higher scores indicate greater depressive symptomatology.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
|
Well-being
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
The scale consists of 14 items rated on a 5-point Likert scale ranging from 1 (never) to 5 (always), with total scores ranging from 14 to 70.
Higher scores indicate greater levels of well-being.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
|
Functionality
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in functional ability will be assessed using the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale.
The scale consists of 8 items and total score ranges from 8 to 30 points, with 8 indicating independence, scores between 9 and 20 indicating moderate dependence and scores above 20 indicating severe dependence.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Global cognitive functioning
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in cognitive functioning will be assessed using the total score of the Neuropsychological Assessment Questionnaire that assesses multiple cognitive functions.
The total score ranges from 0 to 112 points, with higher total scores indicating better cognitive performance.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
|
Visual attention and processing speed
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in visual attention and processing speed will be assessed using the Trail Making Test Part A (TMT-A).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer visual attention and processing speed.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Executive functioning and cognitive flexibility
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in executive functioning and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B).
Performance is measured by the time required to complete the test, with longer completion times indicating poorer executive functioning and cognitive flexibility.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
|
Frontal executive functioning
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in executive functioning will be assessed using Frontal Assessment Battery (FAB), a brief screening tool composed of 6 subtests.
Total scores range from 0 to 18, with higher scores indicating better executive functioning.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Attention and immediate verbal memory
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in attention and immediate verbal memory will be assessed using the Digit Span Forward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences, with higher scores indicating better attention and immediate verbal memory.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Working memory
Tijdsspanne: Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Changes in working memory will be assessed using the Digit Span Backward subtest of the Wechsler Adult Intelligence Scale-III (WAIS-III).
Performance is measured by the number of correctly recalled digit sequences in reverse order, with higher scores indicating better working memory performance.
|
Baseline, post-intervention (at week 7) and follow-up (3 months)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 maart 2027
Studie voltooiing (Geschat)
1 maart 2027
Studieregistratiedata
Eerst ingediend
18 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
13 juli 2026
Eerst geplaatst (Werkelijk)
17 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
13 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2023.03520.BDANA
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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