Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:21 AM
Study NCT ID:
NCT07443657
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nature Exposure Through Virtual Reality (NET-VR) in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Simulator Sickness Questionnaire (SSQ)', 'timeFrame': 'Post-intervention (after 5 weeks)', 'description': 'The Simulator Sickness Questionnaire (SSQ) is a self-report instrument designed to assess symptoms of motion sickness or discomfort experienced during or after virtual reality exposure. The SSQ consists of 16 items grouped into three subscales: Nausea, Oculomotor, and Disorientation. Participants rate the severity of each symptom on a 4-point Likert scale: 0 (None), 1 (Slight), 2 (Moderate), 3 (Severe). Total and subscale scores are calculated according to standardized formulas, with higher scores indicating greater severity of simulator-induced discomfort.'}, {'measure': 'System Usability Scale (SUS)', 'timeFrame': 'Post-intervention (after 5 weeks)', 'description': 'The System Usability Scale (SUS) is a widely used 10-item self-report questionnaire designed to assess perceived usability of a system, product, or technology. Items are rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores converted to a 0-100 scale. Higher scores indicate better perceived usability.'}, {'measure': 'Visual Analogue Scales (VAS) for Immersion, Enjoyment, and Relaxation', 'timeFrame': 'After each VR session (10 sessions per participant over 5 weeks)', 'description': "Visual Analogue Scales (VAS) are self-report measures used to assess participants' subjective experiences after each VR session. Participants provide oral ratings after completing all immersive VR (IVR) tasks in the session. Each scale ranges from 0 (none) to 100 (absolutely). VAS scores assess immersion, enjoyment, and relaxation, with higher scores indicating greater perceived levels of each experience. These measures allow real-time evaluation of participants' engagement and affective response to the VR intervention."}], 'primaryOutcomes': [{'measure': 'Mood - Positive and Negative Affect Schedule', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': "The Positive and Negative Affect Schedule (PANAS) assess two broad domains of affect, termed Positive Affect (PA) and Negative Affect (NA). Both PA and NA represent largely independent constructs ranging from low to high levels of emotional experience . Low PA scores reflect 'sadness and lethargy' whereas high PA scores reflect 'high energy, full concentration, and pleasurable engagement'. Low NA scores describe 'a state of calmness and serenity' whereas high NA scores suggest 'subjective distress and unpleasurable engagement'. The PANAS contains 20 items that yield two subscales (PA, NA) of 10 adjectives each. Participants responded with regards to how they felt 'during the past week' on a 5-point scale from very slightly to very much. Minimum score is 20 and maximum score is 100."}, {'measure': 'Beck Depression Inventory-II', 'timeFrame': 'During and after each session; post-intervention (after 5 weeks)', 'description': 'It assesses the severity of depressive symptoms, specifically evaluating the intensity of depression in psychiatric and general populations aged 13 years and older. It consists of 21 items with four response options ranging from 0 (absence of the symptom) to 3 (greater severity of the symptom). It evaluates symptom severity over the past two weeks, including the day the inventory is completed. The total score ranges from 0 (no depression) to 63 (severe depression).'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': 'The State-Trait Anxiety Inventory (STAI) is a widely used self-report instrument designed to assess anxiety as both a transient emotional state (State Anxiety) and a relatively stable individual difference in anxiety proneness (Trait Anxiety). State Anxiety reflects temporary feelings of tension, nervousness, and apprehension that fluctuate over time and in response to situational stressors, whereas Trait Anxiety reflects a general tendency to perceive situations as threatening and to respond with elevated anxiety. The STAI consists of 40 items divided into two 20-item subscales (State and Trait). Participants rate the intensity or frequency of anxiety-related feelings on a 4-point Likert scale. Higher scores indicate greater levels of anxiety, with total scores ranging from 20 to 80 for each subscale.'}], 'secondaryOutcomes': [{'measure': 'Mindful Attention Awareness Scale and Nature Exposure Scale-II', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': "The Mindful Attention Awareness Scale (MAAS) is a self-report questionnaire designed to assess dispositional mindfulness, defined as an individual's capacity to maintain attention and awareness of present-moment experiences in everyday life. The scale focuses on the presence or absence of mindful attention, particularly lapses in awareness and automatic pilot behaviors. The MAAS consists of 15 items rated on a 6-point Likert scale (1 = Almost Always; 6 = Almost Never). Total scores range from 15 (minimum) to 90 (maximum), with higher scores indicating greater levels of mindful attention and awareness."}, {'measure': 'Contact with Nature Scale (ECN)', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': "The Contact with Nature Scale (ECN) is a self-report instrument adapted into Spanish from the Nature Exposure Scale-II to measure individuals' direct contact with the natural environment. The scale consists of 6 items rated on a 5-point Likert scale (1 = Little/Not at all; 5 = Much/A lot), with total scores ranging from 6 (minimum) to 30 (maximum). Higher scores indicate greater contact with nature, covering everyday interactions, exposure outside routine environments, and contact during physical activity."}, {'measure': 'Stroop Color and Word Test (SCWT)', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': 'The Stroop Color and Word Test (SCWT) is a standardized neuropsychological measure of selective attention, cognitive flexibility, processing speed, and inhibitory control. The test consists of three conditions (word reading, color naming, and color-word interference), each administered with a 45-second time limit per condition, resulting in up to 3 scoring intervals of 45 seconds. Participants are asked to read words or name ink colors as quickly and accurately as possible within each time frame. Performance is measured by the number of correctly completed items per condition and the number of errors. The minimum possible score is 0 correct items per condition, and the typical maximum is determined by the number of items completed within the 45-second limit, with higher correct item counts indicating better cognitive performance (faster processing and stronger inhibitory control). Higher error counts indicate worse performance.'}, {'measure': 'Trail Making Test (TMT A-B)', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': 'The Trail Making Test (TMT) is a widely used neuropsychological measure of visual attention, processing speed, cognitive flexibility, and executive function. It consists of two parts: TMT Part A, which requires participants to connect 25 numbered circles in sequential order as quickly as possible, assessing visual scanning, attention, and psychomotor speed; and TMT Part B, which requires connecting 25 circles alternating between numbers and letters (1-A-2-B…), assessing set-shifting, cognitive flexibility, and executive control. Performance is measured by completion time in seconds and errors for each part. The minimum possible time is 0 seconds, and there is no strict maximum; longer completion times and more errors indicate worse performance. Lower times and fewer errors indicate better cognitive function.'}, {'measure': 'Digit Span', 'timeFrame': 'Baseline and post-intervention (after 5 weeks)', 'description': 'The Digit Span Subtest is a cognitive assessment tool that is part of the Weschler Adult Intelligence Test (WAIS), assesses auditory attention, immediate memory, working memory, and executive function. It consists of two conditions: Digit Span Forward and Digit Span Backward. In the Forward condition, participants repeat sequences of numbers presented orally in the same order; in the Backward condition, participants repeat the numbers in reverse order. Higher total correct scores indicate better attention, immediate memory (Forward), and working memory/executive control (Backward).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nature-based intervention', 'Mental health', 'Virtual Reality (VR)', 'Older adults'], 'conditions': ['Distress, Psychological', 'Negative Affect', 'Cognitive Functioning', 'Older Adults']}, 'descriptionModule': {'briefSummary': 'Daily exposure to nature is associated with improved mood and reduced anxiety symptoms in the overall population. Even brief contact with natural environments can lower stress and restore productivity.However, access to natural environments is often limited, particularly for urban and institutionalized older adults, due to physical, financial, and logistical barriers.These challenges highlight the need for new technologies that can facilitate more regular contact with nature. Virtual Reality (VR)-a digital technology that creates realistic scenes and objects to simulate the experience of being in a natural environment-offers a promising solution, particularly for older adults with physical or financial limitations.The aim of this study is to explore how both older adults might benefit from a mental health program that uses virtual reality to simulate exposure to nature.', 'detailedDescription': 'This study aims to evaluate the feasibility and effectiveness of a virtual reality (VR) system featuring nature-based environments to improve emotional well-being, reduce psychological distress, and enhance cognitive functioning in older adults.\n\nTo achieve this, participants will be assigned to one of two groups: an experimental group that will receive the nature-based VR intervention, and a control group placed on a waiting list. The intervention is expected to have a positive impact on self-reported measures such as mindful awareness, anxiety, depression and cognitive functions (particularly attention and executive functioning) Additionally, usability-related aspects of the technology-such as presence, ease of use, and cybersickness-will also be assessed.\n\nA total of 30 participants will be recruited (aged 60 to 90). Participation is voluntary and will take place at the International University of Catalonia (UIC Barcelona), through face-to-face group sessions.\n\nThe intervention will span 5 weeks, with two 30-minute session per week. Participants will use a VR headset to explore immersive natural environments (e.g., tropical islands, forests, snowy landscapes) via the Nature Treks VR software. Each session will follow a structured protocol with three stages: a training stage, a personalization stage, and a final immersive relaxation stage.\n\nBefore enrollment, participants will undergo an eligibility screening to ensure they meet the inclusion and exclusion criteria, particularly regarding mental and cognitive health. Group allocation will be randomized, and outcome assessments will be conducted by blinded evaluators to reduce bias.\n\nThis study aims to contribute new evidence on the psychological and cognitive benefits of nature-based VR interventions and their usability across different age groups, supporting the development of accessible and innovative tools for mental health and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. being between 60 and 90 years old;\n2. normal or corrected-to-normal vision and hearing.\n\nExclusion criteria (all self-reported:\n\n1. high risk of anxiety and depressive disorders, as assessed by the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7)\n2. Other serious mental disorders with psychotic or manic symptoms (e.g., psychotic disorders, bipolar disorders, etc.), sensory complications that would prevent exposure (e.g., visual or auditory deficits), epilepsy, and other medical conditions (such as, balance/vestibular problem) that would disrupt the VR experience.\n3. High risk of cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA test).'}, 'identificationModule': {'nctId': 'NCT07443657', 'acronym': 'NET-VR', 'briefTitle': 'Nature Exposure Through Virtual Reality (NET-VR) in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Nature Exposure Through Virtual Reality (NET-VR) in Older Adults', 'orgStudyIdInfo': {'id': 'PSI-2024-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Nature VR-based Sessions: The intervention lasts 5 weeks, with sessions twice weekly, 30 minutes each (10 sessions total). Participants use a single IVR headset in face-to-face groups of up to five, supervised by a PhD-level mental health expert. Completion requires attending ≥80% of sessions. The Nature-Trek VR software (Greener Games, USA) simulates diverse natural environments such as tropical islands, forests, lakes, and snow-covered landscapes. Each session features a unique environment. Sessions have three stages: (1) Training (first session only, no direct VR use), (2) Tailoring the VR nature environment, and (3) Immersion, where participants relax and experience the VR setting. Participants remain seated in comfortable chairs with wheels throughout.', 'interventionNames': ['Other: Nature-Based Virtual Reality Intervention']}, {'type': 'OTHER', 'label': 'Control group - waiting list', 'description': 'Participants assigned to the waiting list arm will not receive the VR intervention during the initial 5-week study period and will continue their usual daily routines without any study-related intervention. After the study period, they will be offered the opportunity to experience a single VR session', 'interventionNames': ['Other: Waiting list']}], 'interventions': [{'name': 'Nature-Based Virtual Reality Intervention', 'type': 'OTHER', 'otherNames': ['VR Nature Exposure Intervention', 'Nature-Trek VR', 'Nature-Based Immersive VR'], 'description': 'This intervention uses the commercially available Nature-Trek VR software to immerse participants in diverse natural environments through a virtual reality headset. It is delivered face-to-face in small groups, supervised by a mental health expert, over 5 weeks with twice-weekly 30-minute sessions. The intervention includes a training session, customization of the VR nature environment, and a relaxation immersion stage. It specifically targets reduction of psychological distress and enhancement of cognitive functioning in both young and older adults.', 'armGroupLabels': ['Experimental group']}, {'name': 'Waiting list', 'type': 'OTHER', 'description': 'Participants assigned to the waiting list arm will not receive the VR intervention during the initial 5-week study period and will continue their usual daily routines without any study-related intervention. After the study period, they will be offered the opportunity to experience a single VR session', 'armGroupLabels': ['Control group - waiting list']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}