Golden Age: Virtual Reality and Mindfulness

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

Study Overview

• Status: Completed
• Conditions: Healthy Lifestyle; Psychological Wellbeing
• Intervention / Treatment: Behavioral: Mindfluness and Virtual Reality

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorenzo Di Natale; Phone Number: +39 3356480675; Email: dinatale@idego.it

Study Locations

• Italy
  • Rome, Italy, 00197
    • Idego srl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness 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.	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.
No Intervention: No intervention; This group will only receive questionnaires at the beginning and end of the experiment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Idego srl
• Investigators: Principal Investigator: Lorenzo Di Natale, Idego srl

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: healthy lifestyle; psychological wellbeing
• Other Study ID Numbers: Golden Age 01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
• IPD Sharing Time Frame: Data will be available starting from October 2023 for five years.
• IPD Sharing Access Criteria: The data available on the research website (www.idego.it). A specific page will be create where researchers can download the raw data to perform any analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No