Immersive Nature-Based Wellbeing Program in Older Adults With Cognitive Impairment
ConditionCognitive Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorConsorci Sanitari de Terrassa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Immersive virtual reality program
DeviceParticipants 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.
Treatment groups
230 Participants
are divided into 1 treatment groupGroup A: Immersive virtual reality interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (1 week)Secondary outcomes
1
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (1 week)2
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (1 week)3
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (1 week)4
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.
Time frame
Baseline (pre-intervention) and immediately post-intervention (1 week)Other outcomes
1
Perceived immersion during virtual reality sessions (Self-Assessment Manikin, SAM)
Immersion is assessed using the Self-Assessment Manikin (SAM), a non-verbal pictorial tool that captures participants' subjective experience during exposure to immersive virtual environments.
Time frame
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.2
Participant satisfaction with immersive virtual reality sessions
Satisfaction is assessed using an ad hoc questionnaire evaluating participants' experience, acceptability, and perceived usefulness of the intervention.
Time frame
At the end of virtual reality sessions 4, 7, and 10, during the 1-week intervention period.3
Intervention adherence based on session attendance and completion rates
Adherence is measured by attendance rate and completion of the scheduled sessions.
Time frame
At the end of each intervention day: Day 1 (after session 4), Day 2 (after session 7), and Day 3 (after session 10).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Consorci Sanitari de Terrassa
Lead sponsor
Suara Serveis SCCL
Collaborator
Source ClinicalTrials.gov