Golden Age: Virtual Reality and Mindfulness

Healthy Lifestyle Clinical Trial

Official title:

Golden Age: Virtual Reality and Mindfulness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966844
• Other study ID #: Golden Age 01-2023
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Idego srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 64 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle
• Psychological Wellbeing

Intervention

Behavioral:
• Mindfluness and Virtual Reality
They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.

Locations

Country	Name	City	State
Italy	Idego srl	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Idego srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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