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

13. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cognitive stimulation + VR
Participants receive a cognitive stimulation program with virtual reality.
Verhalten: Cognitive stimulation program
Twelve group sessions of a cognitive stimulation program with virtual reality.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depressive symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Grupo Lusófona

Mitarbeiter

Fundação para a Ciência e a Tecnologia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2023.03520.BDANA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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