Psychological WellbeingNCT05966844
Golden Age: Virtual Reality and Mindfulness
A study testing Mindfluness and Virtual Reality in people with Psychological Wellbeing and Healthy Lifestyle, run by Idego srl at 1 site in Italy.
Trial summary
The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people. Read more about this study
- Who is it for?
- Ages 64 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Wellbeing, Healthy Lifestyle
- What is being tested?
- Mindfluness and Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
- Current use of narcotics or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people.
Read the 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.
- Conditions
- Psychological Wellbeing, Healthy Lifestyle
- Being tested
- Mindfluness and Virtual Reality
- Keywords
- healthy lifestyle, psychological wellbeing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfluness and Virtual RealityBehavioural
They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfluness and Virtual Reality |
| No intervention | No intervention | This group will only receive questionnaires at the beginning and end of the experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two months
Secondary outcomes (1)
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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idego srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Di Natale, Principal investigator, Idego srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966844
- Sponsor's protocol ID
- Golden Age 01-2023
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golden Age: Virtual Reality and Mindfulness
- ClinicalTrials.gov ID
- NCT05966844
- Acronym / sponsor ID
- Golden Age 01-2023
- Conditions
- Psychological Wellbeing, Healthy Lifestyle
- Keywords
- healthy lifestyle, psychological wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Idego srlIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and Virtual Reality | Experimental | Behavioral: Mindfluness and Virtual RealityThis 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. |
| No intervention | No intervention | –This group will only receive questionnaires at the beginning and end of the experiment |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
- Current use of narcotics or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfluness and Virtual RealityThey will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes. | Behavioural | Mindfulness and Virtual Reality |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Level of acceptance and usability of devices
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Yes. Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Di Natale principal investigator
Idego srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfluness and Virtual Reality in people with Psychological Wellbeing and Healthy Lifestyle, run by Idego srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of GAD-7 test scores (time frame: Two months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.