Depressive SymptomsNCT07710222
Cognitive Stimulation Program With Virtual Reality for Older Adults With Depressive Symptoms
A study testing Cognitive stimulation program in people with Depressive Symptoms, run by Grupo Lusófona.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Cognitive stimulation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 years or older attending Portuguese day care centers;
- Presence of mild, moderate, or severe depressive symptomatology;
- Language skills and visual acuity.
Who cannot join
- Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
About this study
Official title: 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.
- Conditions
- Depressive Symptoms
- Being tested
- Cognitive stimulation program
- Keywords
- Depression, Cognitive functioning, Well-being, Functionality, Mental health, Cognitive stimulation program, Virtual reality, Older adults
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation programBehavioural
Twelve group sessions of a cognitive stimulation program with virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive stimulation + VR | Experimental | Participants receive a cognitive stimulation program with virtual reality. Receives: Behavioral: Cognitive stimulation program |
| Wait-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (at week 7)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (at week 7) and follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One experimental group and one wait-list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Lusófona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Sofia Borges de Sousa, Grupo Lusófona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710222
- Sponsor's protocol ID
- 2023.03520.BDANA
- Other IDs
- 2023
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Cognitive Stimulation Program With Virtual Reality: Feasibility and Preliminary Efficacy in Older Adults With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07710222
- Acronym / sponsor ID
- 2023.03520.BDANA
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Cognitive functioning, Well-being, Functionality, Mental health, Cognitive stimulation program, Virtual reality, Older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grupo LusófonaUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One experimental group and one wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive stimulation + VR | Experimental | Behavioral: Cognitive stimulation programParticipants receive a cognitive stimulation program with virtual reality. |
| Wait-list Control | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 65 years or older attending Portuguese day care centers;
- Presence of mild, moderate, or severe depressive symptomatology;
- Language skills and visual acuity.
Key exclusion criteria (1 listed)
- Individuals presenting illiteracy and/or medical diagnosis of neurocognitive disorder or significant cognitive deficits (Mini-Mental State Examination)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive stimulation programTwelve group sessions of a cognitive stimulation program with virtual reality. | Behavioural | Cognitive stimulation + VR |
Primary outcome
Adherence
Time frame: 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
Time frame: 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)
Time frame: 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.
9 secondary outcomes
Depressive symptoms
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Well-being
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Functionality
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Global cognitive functioning
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Visual attention and processing speed
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Executive functioning and cognitive flexibility
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Frontal executive functioning
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Attention and immediate verbal memory
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Working memory
Time frame: Baseline, post-intervention (at week 7) and follow-up (3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation program in people with Depressive Symptoms, run by Grupo Lusófona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Throughout the intervention period (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.