Golden Age: Virtual Reality and Mindfulness

NCT05966844 | Completed

• 1 other identifier: Golden Age 01-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychological Wellbeing; Healthy Lifestyle

Keywords

healthy lifestyle; psychological wellbeing

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Level of acceptance and usability of devices

  Two months

Study Arms (2)

Mindfulness and Virtual Reality

EXPERIMENTAL

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

No intervention

NO INTERVENTION

This group will only receive questionnaires at the beginning and end of the experiment

Interventions

Mindfluness and Virtual Reality BEHAVIORAL

They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.

Mindfulness and Virtual Reality

Eligibility Criteria

• Age: 64 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
• Current use of narcotics or substance abuse

Sponsors & Collaborators

• Idego srl: lead

Study Sites (1)

Idego srl

Rome, 00197, Italy

Location

Study Officials

• Lorenzo Di Natale

  Idego srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 1, 2023
• Study Start: July 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 30, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available starting from October 2023 for five years.
• 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.

Locations

IT (1)