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Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive stimulation + VR
Participants receive a cognitive stimulation program with virtual reality.
Adfærdsmæssigt: Cognitive stimulation program
Twelve group sessions of a cognitive stimulation program with virtual reality.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence
Tidsramme: 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.
Throughout the intervention period (6 weeks)
Acceptability and Feasibility
Tidsramme: 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)
Acceptability and perceived barriers (semi-strutured interviews)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depressive symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Baseline, post-intervention (at week 7) and follow-up (3 months)
Global cognitive functioning
Tidsramme: 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
Tidsramme: 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)
Executive functioning and cognitive flexibility
Tidsramme: 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
Tidsramme: 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)
Attention and immediate verbal memory
Tidsramme: 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)
Working memory
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Grupo Lusófona

Samarbejdspartnere

Fundação para a Ciência e a Tecnologia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023.03520.BDANA

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Kliniske forsøg med Depressive symptomer

Kliniske forsøg med Cognitive stimulation program

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