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/NCT06020170</url>
    </required_header>
    <id_info>
      <org_study_id>83342231</org_study_id>
      <nct_id>NCT06020170</nct_id>
    </id_info>
    <brief_title>Delving Into Participation Patterns in Social Anxiety Studies</brief_title>
    <official_title>Delving Into Participation Patterns in Social Anxiety Clinical Trials and Investigating Engagement Trends Among Individuals Impacted by the Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Power Life Sciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Power Life Sciences 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>
        The study seeks to delve into the firsthand experiences of patients diagnosed with social&#xD;
        anxiety who partake in a separate clinical trial featuring a specific medical intervention.&#xD;
        The primary emphasis will be on meticulously tracking the rates of trial completion and&#xD;
        withdrawal among these individuals.&#xD;
  &#xD;
        By joining this clinical trial, individuals have the unique opportunity to contribute to the&#xD;
        betterment of future social anxiety patients and play an active role in advancing medical&#xD;
        research.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2024</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients who decide to participate in a social anxiety clinical trial</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in social anxiety clinical trial to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Social Anxiety</condition>
    <eligibility>
      <study_pop>
        <textblock>
          People with social anxiety who are actively considering enrolling in an observational&#xD;
          clinical trial, but have not yet completed enrollment and randomization.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient has self-identified as planning to enroll in a clinical trial&#xD;
  &#xD;
            -  Patient has been diagnosed with social anxiety&#xD;
  &#xD;
            -  Patient is a minimum of 18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient does not understand, sign, and return consent form&#xD;
  &#xD;
            -  Inability to perform regular electronic reporting&#xD;
  &#xD;
            -  Patient is pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael B Gill</last_name>
      <role>Study Director</role>
      <affiliation>Power Life Sciences Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael B Gill</last_name>
      <phone>4159004227</phone>
      <email>bask@withpower.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Power Life Sciences</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael B Gill</last_name>
        <phone>415-900-4227</phone>
        <email>https://www.withpower.com/contact-us@withpower.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Alvi T, Kumar D, Tabak BA. Social anxiety and behavioral assessments of social cognition: A systematic review. J Affect Disord. 2022 Aug 15;311:17-30. doi: 10.1016/j.jad.2022.04.130. Epub 2022 Apr 28.</citation>
      <PMID>35490878</PMID>
    </reference>
    <reference>
      <citation>Gao J, Feng Y, Xu S, Wilson A, Li H, Wang X, Sun X, Wang Y. Appearance anxiety and social anxiety: A mediated model of self-compassion. Front Public Health. 2023 Mar 21;11:1105428. doi: 10.3389/fpubh.2023.1105428. eCollection 2023.</citation>
      <PMID>37026142</PMID>
    </reference>
    <reference>
      <citation>Fancourt D, Steptoe A, Bu F. Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study. Lancet Psychiatry. 2021 Feb;8(2):141-149. doi: 10.1016/S2215-0366(20)30482-X. Epub 2020 Dec 9.</citation>
      <PMID>33308420</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>social anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT06020170/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06020170
  org study id: 83342231
  nct id: NCT06020170
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study seeks to delve into the firsthand experiences of patients diagnosed with social
        anxiety who partake in a separate clinical trial featuring a specific medical intervention.
        The primary emphasis will be on meticulously tracking the rates of trial completion and
        withdrawal among these individuals.
  
        By joining this clinical trial, individuals have the unique opportunity to contribute to the
        betterment of future social anxiety patients and play an active role in advancing medical
        research.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to participate in a social anxiety clinical trial
  time frame: 3 months
  measure: Rate of patients who remain in social anxiety clinical trial to trial completion
  time frame: 12 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael B Gill
  role: Study Director
  affiliation: Power Life Sciences Inc.
  last name: Michael B Gill
  phone: 4159004227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Alvi T, Kumar D, Tabak BA. Social anxiety and behavioral assessments of social cognition: A systematic review. J Affect Disord. 2022 Aug 15;311:17-30. doi: 10.1016/j.jad.2022.04.130. Epub 2022 Apr 28.
  PMID: 35490878
  citation: Gao J, Feng Y, Xu S, Wilson A, Li H, Wang X, Sun X, Wang Y. Appearance anxiety and social anxiety: A mediated model of self-compassion. Front Public Health. 2023 Mar 21;11:1105428. doi: 10.3389/fpubh.2023.1105428. eCollection 2023.
  PMID: 37026142
  citation: Fancourt D, Steptoe A, Bu F. Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study. Lancet Psychiatry. 2021 Feb;8(2):141-149. doi: 10.1016/S2215-0366(20)30482-X. Epub 2020 Dec 9.
  PMID: 33308420
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  sharing ipd: Undecided
  provided document: 