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/NCT05991713</url>
    </required_header>
    <id_info>
      <org_study_id>20150678</org_study_id>
      <secondary_id>R01MH133693</secondary_id>
      <nct_id>NCT05991713</nct_id>
    </id_info>
    <brief_title>Geolocation Positional System (GPS) Experience</brief_title>
    <official_title>Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Miami</source>
    <oversight_info>
      <has_dmc>No</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 purpose of this study is to use smartphone technology to capture individual location&#xD;
        emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and&#xD;
        brain activity are related to one another.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The observational portion of this study was initially approved in 2015, this is a subset of&#xD;
        the initially approved study and it is a clinical trial of 100 participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in positive emotional response as measured by ecological momentary assessment</measure>
      <time_frame>Baseline, up to 6 months</time_frame>
      <description>Emotional response will be measured by computing a total mean score of &quot;happy&quot;, &quot;excited&quot;, &quot;content&quot;, &quot;attentive&quot;, &quot;relaxed&quot;. The total mean score ranges from 0 to 100, with higher scores indicating greater positive emotional response.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in negative emotional response as measured by ecological momentary assessment</measure>
      <time_frame>Baseline, up to 6 months</time_frame>
      <description>Emotional response will be measured by computing a total mean score of &quot;sad&quot;, &quot;tired&quot;, &quot;upset&quot;, &quot;irritable&quot;, &quot;anxious&quot;. The total mean score ranges from 0 to 100, with higher scores indicating greater negative emotional response.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Emotions</condition>
    <condition>Anhedonia</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Modifying Exploration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals will be asked on certain days to increase their levels of exploration, and some days be asked to decrease their levels of exploration. Participants will do this for up to six months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Modifying Exploration</intervention_name>
      <description>Participants in this group will use a mobile phone sensor data application that uses an accelerometer, Wireless Fidelity (WiFi) and/or GPS designed for smartphone devices. This technology allows the phones to capture information automatically and passively on the participant's activity. The application will be collecting participants' data 24 hours a day, 7 days a week. Participants will be asked to make alterations to their exploration levels approximately 20 days of their participation in the study.</description>
      <arm_group_label>Modifying Exploration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must agree to give informed consent&#xD;
  &#xD;
            -  Must be willing to have an functional Magnetic Resonance Imaging (FMRI) scan&#xD;
  &#xD;
            -  Must be able to receive and respond to daily text messages assessing current emotion&#xD;
  &#xD;
            -  Must be willing to download and run a GPS tracking application (FollowMee) onto their&#xD;
               smartphone for a four-month period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of head trauma, seizures, or neurological disorders&#xD;
  &#xD;
            -  severe/unstable medical conditions&#xD;
  &#xD;
            -  conditions that interfere with MRI&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  lifetime psychotic/bipolar disorder&#xD;
  &#xD;
            -  chronic/severe substance or alcohol abuse/dependence&#xD;
  &#xD;
            -  antipsychotic medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aaron S Heller, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Claire H Landon, BS</last_name>
      <phone>3052849555</phone>
      <email>chl46@miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Coral Gables</city>
          <state>Florida</state>
          <zip>33146</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Claire H Landon, BS</last_name>
        <phone>305-284-9555</phone>
        <email>chl46@miami.edu</email>
      </contact>
      <investigator>
        <last_name>Aaron S Heller, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Aaron Heller</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anhedonia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05991713
  org study id: 20150678
  secondary id: R01MH133693
  nct id: NCT05991713
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to use smartphone technology to capture individual location
        emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and
        brain activity are related to one another.
  The observational portion of this study was initially approved in 2015, this is a subset of
        the initially approved study and it is a clinical trial of 100 participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in positive emotional response as measured by ecological momentary assessment
  time frame: Baseline, up to 6 months
  description: Emotional response will be measured by computing a total mean score of "happy", "excited", "content", "attentive", "relaxed". The total mean score ranges from 0 to 100, with higher scores indicating greater positive emotional response.
  measure: Change in negative emotional response as measured by ecological momentary assessment
  time frame: Baseline, up to 6 months
  description: Emotional response will be measured by computing a total mean score of "sad", "tired", "upset", "irritable", "anxious". The total mean score ranges from 0 to 100, with higher scores indicating greater negative emotional response.
  arm group label: Modifying Exploration
  arm group type: Experimental
  description: Individuals will be asked on certain days to increase their levels of exploration, and some days be asked to decrease their levels of exploration. Participants will do this for up to six months.
  intervention type: Behavioral
  intervention name: Modifying Exploration
  description: Participants in this group will use a mobile phone sensor data application that uses an accelerometer, Wireless Fidelity (WiFi) and/or GPS designed for smartphone devices. This technology allows the phones to capture information automatically and passively on the participant's activity. The application will be collecting participants' data 24 hours a day, 7 days a week. Participants will be asked to make alterations to their exploration levels approximately 20 days of their participation in the study.
  arm group label: Modifying Exploration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aaron S Heller, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Claire H Landon, BS
  phone: 3052849555
  email: chl46@miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Aaron Heller
  investigator title: Associate Professor
  mesh term: Anhedonia
  sharing ipd: No