Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
13 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adherence
Délai: 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
Délai: Post-intervention (at week 7)
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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.
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Post-intervention (at week 7)
|
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Acceptability and perceived barriers (semi-strutured interviews)
Délai: 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.
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Post-intervention (at week 7)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depressive symptoms
Délai: 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
Délai: 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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Functionality
Délai: 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
Délai: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Visual attention and processing speed
Délai: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
|
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Executive functioning and cognitive flexibility
Délai: 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)
|
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Frontal executive functioning
Délai: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Attention and immediate verbal memory
Délai: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Working memory
Délai: Baseline, post-intervention (at week 7) and follow-up (3 months)
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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.
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Baseline, post-intervention (at week 7) and follow-up (3 months)
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Collaborateurs et enquêteurs
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Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mars 2027
Achèvement de l'étude (Estimé)
1 mars 2027
Dates d'inscription aux études
Première soumission
18 juin 2026
Première soumission répondant aux critères de contrôle qualité
13 juillet 2026
Première publication (Réel)
17 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2023.03520.BDANA
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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