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OpenTrials
Completed

NCT Number: NCT05966844

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.

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Key information

Conditions

Psychological Wellbeing Healthy Lifestyle

Age range

64 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idego srl

Rome, 00197, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Level of acceptance and usability of devices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Idego srl

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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