xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966844</url>
    </required_header>
    <id_info>
      <org_study_id>Golden Age 01-2023</org_study_id>
      <nct_id>NCT05966844</nct_id>
    </id_info>
    <brief_title>Golden Age: Virtual Reality and Mindfulness</brief_title>
    <official_title>Golden Age: Virtual Reality and Mindfulness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Idego srl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Idego srl</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the research is to identify innovative methodologies to improve the psychological&#xD;
        well-being of ageing people.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        With regard to the objectives of the Golden Age project, a software of Immersive Virtual&#xD;
        Reality (VR) for people over 65. The application aims to improve the psychological wellbeing&#xD;
        of ageing people, facilitating the removal of barriers that may represent a risk factor with&#xD;
        respect to the assumption of a healthy and correct nutrition.&#xD;
  &#xD;
        In particular, the elderly will be exposed to naturalistic scenarios in Virtual Reality&#xD;
        combined with Mindfulness audio tracks. The practice of Mindfulness in Virtual Reality will&#xD;
        be used to prevent and intervene on depressive symptoms, stress and anxiety, which represent&#xD;
        the main obstacles to the adoption of healthy behaviours in the elderly person.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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:&#xD;
  An experimental group of 20 elderly people who will do the trial in the RV.&#xD;
  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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in levels of GAD-7 test scores</measure>
      <time_frame>Two months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in levels of PHQ-9 test scores</measure>
      <time_frame>Two months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Perceived Stress Scale test scores</measure>
      <time_frame>Two months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Mindful Awareness Attention Scale scores</measure>
      <time_frame>Two months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of acceptance and usability of devices</measure>
      <time_frame>Two months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Psychological Wellbeing</condition>
    <condition>Healthy Lifestyle</condition>
    <arm_group>
      <arm_group_label>Mindfulness and Virtual Reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will only receive questionnaires at the beginning and end of the experiment</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfluness and Virtual Reality</intervention_name>
      <description>They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.</description>
      <arm_group_label>Mindfulness and Virtual Reality</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Average age over 64&#xD;
  &#xD;
            -  MMSE between 20 and 30&#xD;
  &#xD;
            -  Adequate vision and hearing to see scenarios and hear tracks&#xD;
  &#xD;
            -  sufficient ability to understand procedures and communicate with staff&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  High levels of depression combined with other psychological risk indices (such as&#xD;
               suicidal thoughts)&#xD;
  &#xD;
            -  Current use of narcotics or substance abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>64 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lorenzo Di Natale</last_name>
      <role>Principal Investigator</role>
      <affiliation>Idego srl</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lorenzo Di Natale</last_name>
      <phone>+39 3356480675</phone>
      <email>dinatale@idego.it</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>healthy lifestyle</keyword>
    <keyword>psychological wellbeing</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available starting from October 2023 for five years.</ipd_time_frame>
      <ipd_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_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966844
  org study id: Golden Age 01-2023
  nct id: NCT05966844
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the research is to identify innovative methodologies to improve the psychological
        well-being of ageing people.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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.
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Change in levels of GAD-7 test scores
  time frame: Two months
  description: 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.
  measure: Change in levels of PHQ-9 test scores
  time frame: Two months
  description: 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.
  measure: Change in Perceived Stress Scale test scores
  time frame: Two months
  description: 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.
  measure: Change in Mindful Awareness Attention Scale scores
  time frame: Two months
  description: 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.
  measure: Level of acceptance and usability of devices
  time frame: Two months
  description: 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.
  arm group label: Mindfulness and Virtual Reality
  arm group type: Experimental
  description: 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.
  arm group label: No intervention
  arm group type: No Intervention
  description: This group will only receive questionnaires at the beginning and end of the experiment
  intervention type: Behavioral
  intervention name: Mindfluness and Virtual Reality
  description: They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.
  arm group label: Mindfulness and Virtual Reality
  criteria: 
  gender: All
  minimum age: 64 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lorenzo Di Natale
  role: Principal Investigator
  affiliation: Idego srl
  last name: Lorenzo Di Natale
  phone: +39 3356480675
  email: dinatale@idego.it
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.
  ipd info type: Study Protocol
  ipd time frame: Data will be available starting from October 2023 for five years.
  ipd 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.