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/NCT06034249</url>
    </required_header>
    <id_info>
      <org_study_id>20230816</org_study_id>
      <nct_id>NCT06034249</nct_id>
    </id_info>
    <brief_title>Mindfulness-Based VR for Family Caregivers of People With Dementia</brief_title>
    <official_title>The Effect of Mindfulness-Based VR on Depression, Sleep and Quality of Life Among Family Caregivers of People With Dementia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Taipei Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could&#xD;
        enhance depression, sleep quality, and overall quality of life for family caregivers&#xD;
        providing care for people with dementia.&#xD;
  &#xD;
        Participants will be ask to attend the six-week course encompassed various mindfulness&#xD;
        practices, including breathing observation, body scanning, mindful yoga, mindful walking,&#xD;
        holistic meditation, and non-selective awareness practices. The control group will only be&#xD;
        given the mindfulness-based audio files for six weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The inclusion criteria for participants were as follows: (1) being a family caregiver&#xD;
        responsible for caring for a family member diagnosed with dementia by a medical institution,&#xD;
        (2) having the ability to communicate in Mandarin or Taiwanese, and (3) providing informed&#xD;
        consent to participate in the study by signing the consent form. Individuals with visual and&#xD;
        auditory impairments were excluded from the study.&#xD;
  &#xD;
        Outcome measure: basic characteristics of participants; The Center for Epidemiologic Studies&#xD;
        Depression Scale; Questionnaire of Taiwan's World Health Organization Quality of Life Brief&#xD;
        Version.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 23, 2022</start_date>
    <completion_date type="Actual">June 6, 2023</completion_date>
    <primary_completion_date type="Actual">November 21, 2022</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>A randomized controlled trial (RCT) design was used. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>Baseline and six-week</time_frame>
      <description>The Center for Epidemiologic Studies Depression Scale (CES-D)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>Baseline and six-week</time_frame>
      <description>Chinese Pittsburgh Sleep Quality Index (CPSQI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QoL</measure>
      <time_frame>Baseline and six-week</time_frame>
      <description>Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Caregivers of People With Dementia</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will only be given the mindfulness-based audio files for six weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-Based VR</intervention_name>
      <description>Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Audio</intervention_name>
      <description>The mindfulness-based audio files for six weeks.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. being a family caregiver responsible for caring for a family member diagnosed with&#xD;
               dementia by a medical institution,&#xD;
  &#xD;
            2. having the ability to communicate in Mandarin or Taiwanese, and&#xD;
  &#xD;
            3. providing informed consent to participate in the study by signing the consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Visual and auditory impairments were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Megan F Liu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taipei Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Taipei Medical University</name>
        <address>
          <city>Taipei</city>
          <zip>110</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taipei Medical University</investigator_affiliation>
      <investigator_full_name>Megan F. Liu</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Virtual Reality</keyword>
    <keyword>Depression</keyword>
    <keyword>Sleep Quality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan to make individual participant data (IPD) available to other researchers.</ipd_description>
    </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/NCT06034249
  org study id: 20230816
  nct id: NCT06034249
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could
        enhance depression, sleep quality, and overall quality of life for family caregivers
        providing care for people with dementia.
  
        Participants will be ask to attend the six-week course encompassed various mindfulness
        practices, including breathing observation, body scanning, mindful yoga, mindful walking,
        holistic meditation, and non-selective awareness practices. The control group will only be
        given the mindfulness-based audio files for six weeks.
  The inclusion criteria for participants were as follows: (1) being a family caregiver
        responsible for caring for a family member diagnosed with dementia by a medical institution,
        (2) having the ability to communicate in Mandarin or Taiwanese, and (3) providing informed
        consent to participate in the study by signing the consent form. Individuals with visual and
        auditory impairments were excluded from the study.
  
        Outcome measure: basic characteristics of participants; The Center for Epidemiologic Studies
        Depression Scale; Questionnaire of Taiwan's World Health Organization Quality of Life Brief
        Version.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized controlled trial (RCT) design was used. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Depression
  time frame: Baseline and six-week
  description: The Center for Epidemiologic Studies Depression Scale (CES-D)
  measure: Sleep
  time frame: Baseline and six-week
  description: Chinese Pittsburgh Sleep Quality Index (CPSQI)
  measure: QoL
  time frame: Baseline and six-week
  description: Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version
  arm group label: Experimental group
  arm group type: Experimental
  description: Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: The control group will only be given the mindfulness-based audio files for six weeks.
  intervention type: Behavioral
  intervention name: Mindfulness-Based VR
  description: Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.
  arm group label: Experimental group
  intervention type: Behavioral
  intervention name: Audio
  description: The mindfulness-based audio files for six weeks.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Megan F Liu, PhD
  role: Principal Investigator
  affiliation: Taipei Medical University
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Taipei Medical University
  investigator full name: Megan F. Liu
  investigator title: Associate Professor
  mesh term: Dementia
  sharing ipd: No
  ipd description: No plan to make individual participant data (IPD) available to other researchers.