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Trial · NCT07443657

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMood - Positive and Negative Affect ScheduleBaseline and post-intervention (after 5 weeks)
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.
PrimaryBeck Depression Inventory-IIDuring and after each session; post-intervention (after 5 weeks)
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).
PrimaryState-Trait Anxiety Inventory (STAI)Baseline and post-intervention (after 5 weeks)
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.
SecondaryMindful Attention Awareness Scale and Nature Exposure Scale-IIBaseline and post-intervention (after 5 weeks)
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.
SecondaryContact with Nature Scale (ECN)Baseline and post-intervention (after 5 weeks)
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.
SecondaryStroop Color and Word Test (SCWT)Baseline and post-intervention (after 5 weeks)
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.
SecondaryTrail Making Test (TMT A-B)Baseline and post-intervention (after 5 weeks)
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.
SecondaryDigit SpanBaseline and post-intervention (after 5 weeks)
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).
OtherSimulator Sickness Questionnaire (SSQ)Post-intervention (after 5 weeks)
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.
OtherSystem Usability Scale (SUS)Post-intervention (after 5 weeks)
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.
OtherVisual Analogue Scales (VAS) for Immersion, Enjoyment, and RelaxationAfter each VR session (10 sessions per participant over 5 weeks)
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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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