Cognitive DysfunctionCOGNITIONCT07802392
Immersive Nature-Based Wellbeing Program in Older Adults With Cognitive Impairment
A study testing Immersive virtual reality program in people with Cognitive Dysfunction, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Immersive virtual reality program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2026to Dec 2026
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- Diagnosis of mild or moderate cognitive impairment
- Ability to understand study procedures and follow instructions
- Ability to provide informed consent (or consent provided by a legal representative)
- Attendance at participating day care centers or residential facilities (Phase 2)
- For Phase 1: healthy adults without cognitive impairment
Who cannot join
- Severe cognitive impairment or diagnosis of advanced dementia
- Severe visual, auditory, or motor impairments that prevent use of virtual reality
- Neurological or psychiatric conditions that may interfere with participation
- History of epilepsy or conditions contraindicating virtual reality exposure
- Severe behavioral disturbances or agitation
- Participation in other clinical studies that may interfere with results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Maite Garolera, PhD, +34937310007 ext. 1758, mgarolera@cst.cat
About this study
Official title: Cognitio Avançada: Immersive Nature-Based Wellbeing Program for Older Adults With Cognitive Impairment: A Quasi-Experimental Pre-Post Study
This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging.
The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions.
Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.
Read the detailed description
This study evaluates the effectiveness of an immersive virtual reality program based on nature environments to improve cognitive function, emotional well-being, functional ability, and quality of life in older adults with mild to moderate cognitive impairment.
Cognitive impairment is common in older adults and can negatively affect independence, emotional well-being, and quality of life. Non-pharmacological interventions using emerging technologies, such as immersive virtual reality, offer new opportunities to support cognitive and emotional health. Nature-based virtual environments may help reduce stress, improve mood, and increase engagement, even in individuals with limited mobility or access to natural settings.
The study takes place across services affiliated with Suara Cooperativa. In Phase 1, researchers test and validate immersive virtual environments in healthy participants. Participants attend individual sessions where they view nature-based virtual scenarios. Researchers collect behavioral, subjective, and physiological data, including electroencephalography, heart rate, electrodermal activity, and respiration, to assess safety, usability, and emotional responses to the virtual environments.
In Phase 2, researchers conduct a quasi-experimental pre-post study without a control group. The study includes 200 participants (100 with mild cognitive impairment and 100 with moderate cognitive impairment) recruited from day care centers and residential facilities managed by Suara Cooperativa.
Participants take part in a structured group-based intervention consisting of 10 immersive virtual reality sessions. The program combines exposure to nature-based virtual environments with mindfulness practices, cognitive stimulation activities, and breathing techniques to promote emotional regulation and cognitive engagement. The intervention is accessible, engaging, and adapted to the needs of older adults with cognitive impairment.
Primary outcome measures include cognitive function, emotional well-being, functional capacity in activities of daily living, and quality of life. Researchers also assess participant engagement and acceptability of the intervention as secondary measures.
Researchers analyze data using descriptive and inferential statistical methods to assess changes between pre- and post-intervention measures. They also evaluate adherence to the intervention and participant satisfaction.
This study aims to generate evidence on the potential of immersive virtual reality as an innovative, safe, and accessible non-pharmacological intervention to support cognitive health, emotional well-being, and autonomy in older adults, contributing to active and healthy aging.
- Conditions
- Cognitive Dysfunction
- Being tested
- Immersive virtual reality program
- Keywords
- Immersive Virtual Reality, Cognitive Impairment, Older Adults, Well-being, Quality of Life, Blue and Green Spaces, Cognitive Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality programDevice
Participants receive an immersive virtual reality intervention using nature-based environments. The program consists of 10 group sessions that combine mindfulness, cognitive stimulation, and breathing techniques to promote cognitive and emotional well-being.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality intervention | Experimental | Participants receive a group-based immersive virtual reality intervention consisting of 10 sessions using nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. Receives: Device: Immersive virtual reality program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function (verbal fluency and Digit Span tests)
Cognitive function is assessed using verbal fluency tasks and Digit Span tests (forward and backward). Verbal fluency evaluates language and executive function by measuring the number of words generated under specific conditions. Digit Span forward assesses attention, while Digit Span backward assesses working memory. Higher scores indicate better cognitive performance.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Secondary outcomes (6)
Change in anxiety symptoms (Generalized Anxiety Disorder 7-item scale [GAD-7])
Anxiety symptoms are assessed using the GAD-7 questionnaire, a validated self-report scale measuring severity of generalized anxiety symptoms. Higher scores indicate greater anxiety.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Short-form Yesavage Geriatric Depression Scale (GDS-SF)
Depressive symptoms are assessed using the GDS-SF, a validated screening tool for depression in older adults. Higher scores indicate greater depressive symptomatology.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in positive and negative affect (Positive and Negative Affect Schedule-10 [PANAS-10])
Affective state is assessed using the PANAS-10, which measures positive and negative affect. Higher scores reflect higher levels of the corresponding affect.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in loneliness (UCLA Loneliness Scale, UCLA-10)
Loneliness is assessed using the UCLA-10 scale, a validated self-report measure of perceived social isolation. Higher scores indicate greater loneliness.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in quality of life (EuroQol 5-Dimension 5-Level questionnaire [EQ-5D-5L])
Quality of life is assessed using the EuroQol-5D-5L questionnaire, which evaluates health status across five dimensions. Higher index values indicate better perceived health-related quality of life.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in functional ability (Bayer Activities of Daily Living Scale [BAYER-ADL])
Functional ability is assessed using the Bayer Activities of Daily Living Scale, which measures impairments in instrumental activities of daily living. Higher scores indicate greater functional impairment.
Measured: Baseline (pre-intervention) and immediately post-intervention (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start31 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Suara Serveis SCCL
- Responsible party
- Principal investigator, Maite Garolera, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802392
- Sponsor's protocol ID
- DDS027/24/000611
- Acronym
- COGNITIO
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitio Avançada: Immersive Nature-Based Wellbeing Program for Older Adults With Cognitive Impairment: A Quasi-Experimental Pre-Post Study
- ClinicalTrials.gov ID
- NCT07802392
- Acronym / sponsor ID
- COGNITIO / DDS027/24/000611
- Conditions
- Cognitive Dysfunction
- Keywords
- Immersive Virtual Reality, Cognitive Impairment, Older Adults, Well-being, Quality of Life, Blue and Green Spaces, Cognitive Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Suara Serveis SCCL
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 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.
This study aims to evaluate an immersive virtual reality program designed to support cognitive and emotional well-being in older adults with mild to moderate cognitive impairment. The program uses nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. The goal is to determine whether immersive virtual reality can be a safe and effective tool to improve well-being and support active and healthy aging.
The study will be conducted in two phases. In the first phase, virtual environments will be tested in healthy participants using behavioral and physiological measures. In the second phase, 200 older adults with cognitive impairment from day care centers and residential facilities will participate in a group-based immersive virtual reality intervention consisting of 10 sessions.
Researchers will assess changes in cognitive function, emotional wellbeing, daily functioning, and quality of life before and after the intervention.
Detailed description
This study evaluates the effectiveness of an immersive virtual reality program based on nature environments to improve cognitive function, emotional well-being, functional ability, and quality of life in older adults with mild to moderate cognitive impairment.
Cognitive impairment is common in older adults and can negatively affect independence, emotional well-being, and quality of life. Non-pharmacological interventions using emerging technologies, such as immersive virtual reality, offer new opportunities to support cognitive and emotional health. Nature-based virtual environments may help reduce stress, improve mood, and increase engagement, even in individuals with limited mobility or access to natural settings.
The study takes place across services affiliated with Suara Cooperativa. In Phase 1, researchers test and validate immersive virtual environments in healthy participants. Participants attend individual sessions where they view nature-based virtual scenarios. Researchers collect behavioral, subjective, and physiological data, including electroencephalography, heart rate, electrodermal activity, and respiration, to assess safety, usability, and emotional responses to the virtual environments.
In Phase 2, researchers conduct a quasi-experimental pre-post study without a control group. The study includes 200 participants (100 with mild cognitive impairment and 100 with moderate cognitive impairment) recruited from day care centers and residential facilities managed by Suara Cooperativa.
Participants take part in a structured group-based intervention consisting of 10 immersive virtual reality sessions. The program combines exposure to nature-based virtual environments with mindfulness practices, cognitive stimulation activities, and breathing techniques to promote emotional regulation and cognitive engagement. The intervention is accessible, engaging, and adapted to the needs of older adults with cognitive impairment.
Primary outcome measures include cognitive function, emotional well-being, functional capacity in activities of daily living, and quality of life. Researchers also assess participant engagement and acceptability of the intervention as secondary measures.
Researchers analyze data using descriptive and inferential statistical methods to assess changes between pre- and post-intervention measures. They also evaluate adherence to the intervention and participant satisfaction.
This study aims to generate evidence on the potential of immersive virtual reality as an innovative, safe, and accessible non-pharmacological intervention to support cognitive health, emotional well-being, and autonomy in older adults, contributing to active and healthy aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality intervention | Experimental | Device: Immersive virtual reality programParticipants receive a group-based immersive virtual reality intervention consisting of 10 sessions using nature-based environments combined with mindfulness, cognitive stimulation, and breathing techniques. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years
- Diagnosis of mild or moderate cognitive impairment
- Ability to understand study procedures and follow instructions
- Ability to provide informed consent (or consent provided by a legal representative)
- Attendance at participating day care centers or residential facilities (Phase 2)
Key exclusion criteria (6 listed)
- Severe cognitive impairment or diagnosis of advanced dementia
- Severe visual, auditory, or motor impairments that prevent use of virtual reality
- Neurological or psychiatric conditions that may interfere with participation
- History of epilepsy or conditions contraindicating virtual reality exposure
- Severe behavioral disturbances or agitation
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 |
|---|---|---|
| Immersive virtual reality programParticipants receive an immersive virtual reality intervention using nature-based environments. The program consists of 10 group sessions that combine mindfulness, cognitive stimulation, and breathing techniques to promote cognitive and emotional well-being. | Device | Immersive virtual reality intervention |
Primary outcome
Change in cognitive function (verbal fluency and Digit Span tests)
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Cognitive function is assessed using verbal fluency tasks and Digit Span tests (forward and backward). Verbal fluency evaluates language and executive function by measuring the number of words generated under specific conditions. Digit Span forward assesses attention, while Digit Span backward assesses working memory. Higher scores indicate better cognitive performance.
6 secondary outcomes
Change in anxiety symptoms (Generalized Anxiety Disorder 7-item scale [GAD-7])
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Short-form Yesavage Geriatric Depression Scale (GDS-SF)
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in positive and negative affect (Positive and Negative Affect Schedule-10 [PANAS-10])
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in loneliness (UCLA Loneliness Scale, UCLA-10)
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in quality of life (EuroQol 5-Dimension 5-Level questionnaire [EQ-5D-5L])
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
Change in functional ability (Bayer Activities of Daily Living Scale [BAYER-ADL])
Time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)
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 3 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality program in people with Cognitive Dysfunction, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Maite Garolera, PhD (+34937310007 ext. 1558, mgarolera@cst.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (verbal fluency and Digit Span tests) (time frame: Baseline (pre-intervention) and immediately post-intervention (1 week)). 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 3 Sep 2026.