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Clinical Trials/NCT05966844
NCT05966844
Completed
Not Applicable

Golden Age: Virtual Reality and Mindfulness

Idego srl1 site in 1 country40 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Wellbeing
Sponsor
Idego srl
Enrollment
40
Locations
1
Primary Endpoint
Change in levels of GAD-7 test scores
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Idego srl
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in levels of GAD-7 test scores

Time Frame: Two months

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.

Change in levels of PHQ-9 test scores

Time Frame: Two months

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.

Change in Perceived Stress Scale test scores

Time Frame: Two months

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.

Change in Mindful Awareness Attention Scale scores

Time Frame: Two months

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.

Secondary Outcomes

  • Level of acceptance and usability of devices(Two months)

Study Sites (1)

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