Golden Age: Virtual Reality and Mindfulness

Study Overview
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Brief Summary
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The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people.

Detailed Description
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With regard to the objectives of the Golden Age project, a software of Immersive Virtual Reality (VR) for people over 65. The application aims to improve the psychological wellbeing of ageing people, facilitating the removal of barriers that may represent a risk factor with respect to the assumption of a healthy and correct nutrition. In particular, the elderly will be exposed to naturalistic scenarios in Virtual Reality combined with Mindfulness audio tracks. The practice of Mindfulness in Virtual Reality will be used to prevent and intervene on depressive symptoms, stress and anxiety, which represent the main obstacles to the adoption of healthy behaviours in the elderly person.

Official Title
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Golden Age: Virtual Reality and Mindfulness

Conditions
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Psychological Wellbeing, Healthy Lifestyle

Intervention / Treatment
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* Behavioral: Mindfluness and Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Average age over 64 MMSE between 20 and 30 Adequate vision and hearing to see scenarios and hear tracks sufficient ability to understand procedures and communicate with staff Exclusion Criteria: High levels of depression combined with other psychological risk indices (such as suicidal thoughts) Current use of narcotics or substance abuse

Ages Eligible for Study
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Minimum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The project will investigate the effects of a Mindfulness pathway in RV on factors that hinder the adoption of healthy eating behaviour in the elderly population. Six meetings of about 5-10 minutes each, one per week, are planned. A randomised controlled trial (RCT) is proposed with two groups: An experimental group of 20 elderly people who will do the trial in the RV. Another control group, again of the same size, which will simply fill out simply twice the same battery of tests: one at the beginning of the project and the other at the end.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness and Virtual Reality<br>This group will receive questionnaires at the beginning and end of the trial. In addition, they will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes. | Behavioral: Mindfluness and Virtual Reality<br>* They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.<br>|
| No Intervention: No intervention<br>This group will only receive questionnaires at the beginning and end of the experiment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of GAD-7 test scores | The GAD-7 test is a validated test for the detection of generalized anxiety disorder. GAD-7 total score for the seven items ranges from 0 to 21. Higher scores mean worse outcome. | Two months | 
| Change in levels of PHQ-9 test scores | The PHQ-9 test is a validated test for the detection of depression. The PHQ-9 score ranges from 0 to 24. Higher scores mean worse outcome. | Two months | 
| Change in Perceived Stress Scale test scores | The Perceived Stress Scale (PSS) test is a validated test for detecting general stress levels. The minimum score is 0 and the maximum score is 40. Higher scores mean worse outcome. | Two months | 
| Change in Mindful Awareness Attention Scale scores | The Italian Adaptation of the Mindful Awareness Attention Scale is a questionnaire investigating the presence of mindfulness skills.The minimum score is 15 and the maximum score is 105. A high score indicates an improvement. | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of acceptance and usability of devices | Through a specifically designed questionnaire, the extent to which the devices used are perceived as useful, easy to use and accepted will be assessed. Questions on a 5-point likert scale will be used. | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy lifestyle, psychological wellbeing