Golden Age: Virtual Reality and Mindfulness

Not Applicable

Completed

• Conditions: Psychological Wellbeing; Healthy Lifestyle
• Interventions: Behavioral: Mindfluness and Virtual Reality

• Registration Number: NCT05966844
• Lead Sponsor: Idego srl

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.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness and Virtual Reality	Mindfluness and Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Change in levels of GAD-7 test scores	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	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	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	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 Outcome Measures

Name	Time	Method
Level of acceptance and usability of devices	Two months	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.

Trial Locations

Locations (1)

Idego srl; 🇮🇹 Rome, Italy