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/NCT05989529</url>
    </required_header>
    <id_info>
      <org_study_id>80910613</org_study_id>
      <nct_id>NCT05989529</nct_id>
    </id_info>
    <brief_title>Delving Into Borderline Personality Disorder Clinical Trial Experiences</brief_title>
    <official_title>Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder</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>
        Taking part in medical study usually favors a particular demographic group. But there is&#xD;
        limited research available to explain what trial attributes affect the completion of these&#xD;
        specific demographic groups.&#xD;
  &#xD;
        This study will admit a wide range of data on the clinical research experience of borderline&#xD;
        personality disorder patients to determine which factors prevail in limiting a patient's&#xD;
        ability to join or finish a trial.&#xD;
  &#xD;
        It will also try to analyze data from the perspective of different demographic groups to&#xD;
        check for recurring trends which might yield insights for the sake of future borderline&#xD;
        personality disorder patients.&#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 enroll in a borderline personality disorder clinical research</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of patients who remain in borderline personality disorder clinical research to trial completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Borderline Personality Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with borderline personality disorder who are actively considering enrolling in an&#xD;
          observational clinical trial but have not yet completed enrollment and randomization phases&#xD;
          in said clinical trial.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged ≥ 18 years old&#xD;
  &#xD;
            -  Clinical diagnosis of Borderline Personality Disorder&#xD;
  &#xD;
            -  Able to comprehend the investigational nature of the protocol and provide informed&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No diagnosis of Borderline Personality Disorder confirmed&#xD;
  &#xD;
            -  Inability to perform regular electronic reporting&#xD;
  &#xD;
            -  Patient does not understand, sign, and return consent form&#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>415-900-4227</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>Garcia MC. [Treatment of borderline personality disorder with opioid antagonists: buprenorphine, nalmefene, naloxone and naltrexone in the treatment of dissociative symptoms, self-mutilation and suicidal behavior]. Vertex. 2020 Apr;XXX(148):1-10. doi: 10.53680/vertex.v30i148.122. Spanish.</citation>
      <PMID>33890928</PMID>
    </reference>
    <reference>
      <citation>Kvarstein EH, Froyhaug M, Pettersen MS, Carlsen S, Ekberg A, Fjermestad-Noll J, Ulvestad DA, Gikling EL, Hjermann E, Lindberget K, Omvik S, Eikenaes IU, Hummelen B, Morken KTE, Wilberg T, Pedersen GAF. Improvement of personality functioning among people treated within personality disorder mental health services. A longitudinal, observational study. Front Psychiatry. 2023 May 9;14:1163347. doi: 10.3389/fpsyt.2023.1163347. eCollection 2023.</citation>
      <PMID>37229394</PMID>
    </reference>
    <reference>
      <citation>Jacob GA, Hauer A, Kohne S, Assmann N, Schaich A, Schweiger U, Fassbinder E. A Schema Therapy-Based eHealth Program for Patients with Borderline Personality Disorder (priovi): Naturalistic Single-Arm Observational Study. JMIR Ment Health. 2018 Dec 17;5(4):e10983. doi: 10.2196/10983.</citation>
      <PMID>30559092</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>borderline personality disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Personality Disorders</mesh_term>
      <mesh_term>Borderline Personality Disorder</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 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT05989529/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/NCT05989529
  org study id: 80910613
  nct id: NCT05989529
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Taking part in medical study usually favors a particular demographic group. But there is
        limited research available to explain what trial attributes affect the completion of these
        specific demographic groups.
  
        This study will admit a wide range of data on the clinical research experience of borderline
        personality disorder patients to determine which factors prevail in limiting a patient's
        ability to join or finish a trial.
  
        It will also try to analyze data from the perspective of different demographic groups to
        check for recurring trends which might yield insights for the sake of future borderline
        personality disorder patients.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Number of patients who decide to enroll in a borderline personality disorder clinical research
  time frame: 3 months
  measure: Rate of patients who remain in borderline personality disorder clinical research 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: 415-900-4227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Garcia MC. [Treatment of borderline personality disorder with opioid antagonists: buprenorphine, nalmefene, naloxone and naltrexone in the treatment of dissociative symptoms, self-mutilation and suicidal behavior]. Vertex. 2020 Apr;XXX(148):1-10. doi: 10.53680/vertex.v30i148.122. Spanish.
  PMID: 33890928
  citation: Kvarstein EH, Froyhaug M, Pettersen MS, Carlsen S, Ekberg A, Fjermestad-Noll J, Ulvestad DA, Gikling EL, Hjermann E, Lindberget K, Omvik S, Eikenaes IU, Hummelen B, Morken KTE, Wilberg T, Pedersen GAF. Improvement of personality functioning among people treated within personality disorder mental health services. A longitudinal, observational study. Front Psychiatry. 2023 May 9;14:1163347. doi: 10.3389/fpsyt.2023.1163347. eCollection 2023.
  PMID: 37229394
  citation: Jacob GA, Hauer A, Kohne S, Assmann N, Schaich A, Schweiger U, Fassbinder E. A Schema Therapy-Based eHealth Program for Patients with Borderline Personality Disorder (priovi): Naturalistic Single-Arm Observational Study. JMIR Ment Health. 2018 Dec 17;5(4):e10983. doi: 10.2196/10983.
  PMID: 30559092
  responsible party type: Sponsor
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder
  sharing ipd: Undecided
  provided document: 