An interventional study of Cognitive stimulation program in Depressive Symptoms, sponsored by Grupo Lusófona. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Grupo Lusófona · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Grupo Lusófona is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a cognitive stimulation program with virtual reality.
Behavioral: Cognitive stimulation program
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.
Twelve group sessions of a cognitive stimulation program with virtual reality.
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.
Time frame: Throughout the intervention period (6 weeks)
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.
Time frame: Post-intervention (at week 7)
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.
Time frame: Post-intervention (at week 7)
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Visual attention and processing speed
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Executive functioning and cognitive flexibility
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Frontal executive functioning
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Attention and immediate verbal memory
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Working memory
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.
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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