Depressive Symptoms
Conditions
Keywords
Depression, Cognitive functioning, Well-being, Functionality, Mental health, Cognitive stimulation program, Virtual reality, Older adults
Brief summary
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.
Interventions
BEHAVIORALCognitive stimulation program
Twelve group sessions of a cognitive stimulation program with virtual reality.
Sponsors
Grupo Lusófona
Fundação para a Ciência e a Tecnologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
One experimental group and one wait-list control group.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 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. |
| Acceptability and Feasibility | 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. |
| Acceptability and perceived barriers (semi-strutured interviews) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 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. |
| Well-being | 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. |
| Functionality | 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. |
| Global cognitive functioning | 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. |
| Visual attention and processing speed | 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. |
| Executive functioning and cognitive flexibility | 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. |
| Frontal executive functioning | 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. |
| Attention and immediate verbal memory | 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. |
| Working memory | 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. |
Outcome results
None listed