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/NCT05979922</url>
    </required_header>
    <id_info>
      <org_study_id>Pz-A108a</org_study_id>
      <nct_id>NCT05979922</nct_id>
    </id_info>
    <brief_title>Mindfulness-based Cognitive Coping for ADRD Caregivers</brief_title>
    <official_title>Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals With Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Photozig, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Photozig, Inc.</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>
        This project will evaluate the effectiveness of the Mindfulness-based Cognitive Coping (MCC)&#xD;
        intervention to alleviate stress and depressive symptoms of caregivers of Individuals with&#xD;
        Alzheimer's Disease and Related Dementia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>Phase 2</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Center for Epidemiological Studies Depression Scale</measure>
      <time_frame>3 months</time_frame>
      <description>The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>3 months</time_frame>
      <description>The &quot;Perceived Stress Scale&quot; measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Caregiver Stress</condition>
    <arm_group>
      <arm_group_label>Caring Mind mobile app</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional educational program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-based Cognitive Coping</intervention_name>
      <description>Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.</description>
      <arm_group_label>Caring Mind mobile app</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Traditional Educational/Resources Program</intervention_name>
      <description>Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.</description>
      <arm_group_label>Traditional educational program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Care for an individual with Alzheimer's Disease or Related Dementia (ADRD).&#xD;
  &#xD;
            -  Own a smartphone or tablet and have Internet access.&#xD;
  &#xD;
            -  Minimum age of 18 years old.&#xD;
  &#xD;
            -  Able to read and speak English.&#xD;
  &#xD;
            -  Spend at least 8 hours/week caring for a person with dementia.&#xD;
  &#xD;
            -  Plan to stay in the area for six months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe psychological or physical illness.&#xD;
  &#xD;
            -  Cognitive impairment or any serious medical problem that interferes with caregiving&#xD;
               role.&#xD;
  &#xD;
            -  Caring for ADRD patient with a life expectancy less than six months.&#xD;
  &#xD;
            -  Unwillingness to participate in all aspects of 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_contact>
      <last_name>Bruno Kajiyama</last_name>
      <phone>855-955-CARE</phone>
      <email>caring@photozig.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Photozig, Inc.</name>
        <address>
          <city>Campbell</city>
          <state>California</state>
          <zip>95008-5570</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bruno Kajiyama</last_name>
        <phone>855-955-2273</phone>
        <email>caring@photozig.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05979922
  org study id: Pz-A108a
  nct id: NCT05979922
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This project will evaluate the effectiveness of the Mindfulness-based Cognitive Coping (MCC)
        intervention to alleviate stress and depressive symptoms of caregivers of Individuals with
        Alzheimer's Disease and Related Dementia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Center for Epidemiological Studies Depression Scale
  time frame: 3 months
  description: The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.
  measure: Perceived Stress Scale
  time frame: 3 months
  description: The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
  arm group label: Caring Mind mobile app
  arm group type: Experimental
  description: Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.
  arm group label: Traditional educational program
  arm group type: Active Comparator
  description: Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
  intervention type: Behavioral
  intervention name: Mindfulness-based Cognitive Coping
  description: Participants will receive the Caring Mind mobile app containing the Mindfulness-based Cognitive Coping program.
  arm group label: Caring Mind mobile app
  intervention type: Behavioral
  intervention name: Traditional Educational/Resources Program
  description: Participants will receive a traditional educational/resources program, containing a downloadable workbook and online resources.
  arm group label: Traditional educational program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bruno Kajiyama
  phone: 855-955-CARE
  email: caring@photozig.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor