About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 65 years or older attending Portuguese day care centers;
Presence of mild, moderate, or severe depressive symptomatology;
Language skills and visual acuity.
Disqualifiers
Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
Trial design
Parallel
Treatments tested in this trial
Cognitive stimulation program
BehavioralTwelve group sessions of a cognitive stimulation program with virtual reality.
Treatment groups
Trial outcomes
Primary outcomes
Adherence
The proportion of participants who complete all intervention sessions. Adherence will be considered achieved if at least 70% of participants complete all scheduled sessions.
Acceptability and Feasibility
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.
Acceptability and perceived barriers (semi-strutured interviews)
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.
Secondary outcomes
Depressive symptoms
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.
Well-being
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.
Functionality
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.
Global cognitive functioning
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.
Locations
Sponsors and contacts
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Grupo Lusófona
Lead sponsor
Fundação para a Ciência e a Tecnologia
Collaborator
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