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/NCT06005779</url>
    </required_header>
    <id_info>
      <org_study_id>KY2018.77</org_study_id>
      <nct_id>NCT06005779</nct_id>
    </id_info>
    <brief_title>A Study on the Outcome and Its Influencing Factors in Patients With Borderline Personality Disorder</brief_title>
    <official_title>An Ambispective Cohort Study on the Prognosis and Its Influencing Factors of Borderline Personality Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Mental Health Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Mental Health Centre</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>
        Borderline personality disorder (BPD) is a difficult chronic mental illness. This diagnosis&#xD;
        is common in Western countries. Our researchers want to study the outcome and its influencing&#xD;
        factors of BPD for the first time in China. Patients with BPD who had been hospitalized in&#xD;
        Wuhan Mental Health Center were selected as the subjects. The researchers retrospectively&#xD;
        collected the most recent hospitalization data of these patients, and then prospectively&#xD;
        follow up them for 2 years to see how their condition will change. By analyzing all data,&#xD;
        researchers hope to know deeply about the development law of this illness, and to provide&#xD;
        evidence for releasing these patients' suffering.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is an ambispective cohort study. The information collected in the retrospective&#xD;
        part mainly included demographic data, comorbid psychiatric diagnosis, psychotherapeutive and&#xD;
        pharmacotherapeutive data, times of hospitalization and patients' contact information. The&#xD;
        above data were derived from electronic medical records. After informed consent, prospective&#xD;
        follow-up was initiated primarily by telephone interviews and web-based questionnaires, or by&#xD;
        in-person assessments at hospital return visits. Enrolled patients will be followed up at&#xD;
        6-month intervals after the first follow-up to assess psychiatric diagnosis, social function,&#xD;
        and quality of life. The researchers are senior psychiatrists, all of whom received training&#xD;
        on the use of questionnaires and inter-investigator consistency before the follow-up.&#xD;
  &#xD;
        Cox Proportional Hazard Model is used to analyze the influencing factors of remission of BPD,&#xD;
        and Generalized Estimating Equation Model is used to analyze the influencing factors of the&#xD;
        patients' social function and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 22, 2021</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>remission rate</measure>
      <time_frame>After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.</time_frame>
      <description>The remission rate is calculated as the number of patients who no longer met the diagnostic criteria for BPD for at least 6 months divided by the total number of enrolled patients. The diagnostic tool is ICD-10 (F60.3).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>social disability</measure>
      <time_frame>After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.</time_frame>
      <description>Social disability refers to the patient's occupation, family, social life, personal life and other aspects of functional deficits, using Social Disability Screening Schedule (SDSS) to assess.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>quality of life</measure>
      <time_frame>After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.</time_frame>
      <description>Someone's quality of life is the extent to which their life is comfortable or satisfying. The study used WHOQOL-BREF to assess patients' quality of life in the physical, psychological, social relationship, and environmental domains.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">270</enrollment>
    <condition>Borderline Personality Disorder</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Inpatients at the Wuhan Mental Health Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of BPD based on ICD-10 (F60.3)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Comorbidity with severe physical disease&#xD;
  &#xD;
            -  Comorbidity with neurological diseases such as epilepsy&#xD;
  &#xD;
            -  Comorbidity with mental retardation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fan Yang, Master</last_name>
      <role>Study Director</role>
      <affiliation>Wuhan Mental Health Centre</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Wuhan Mental Health Centre</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430014</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <!-- 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/NCT06005779
  org study id: KY2018.77
  nct id: NCT06005779
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Borderline personality disorder (BPD) is a difficult chronic mental illness. This diagnosis
        is common in Western countries. Our researchers want to study the outcome and its influencing
        factors of BPD for the first time in China. Patients with BPD who had been hospitalized in
        Wuhan Mental Health Center were selected as the subjects. The researchers retrospectively
        collected the most recent hospitalization data of these patients, and then prospectively
        follow up them for 2 years to see how their condition will change. By analyzing all data,
        researchers hope to know deeply about the development law of this illness, and to provide
        evidence for releasing these patients' suffering.
  This study is an ambispective cohort study. The information collected in the retrospective
        part mainly included demographic data, comorbid psychiatric diagnosis, psychotherapeutive and
        pharmacotherapeutive data, times of hospitalization and patients' contact information. The
        above data were derived from electronic medical records. After informed consent, prospective
        follow-up was initiated primarily by telephone interviews and web-based questionnaires, or by
        in-person assessments at hospital return visits. Enrolled patients will be followed up at
        6-month intervals after the first follow-up to assess psychiatric diagnosis, social function,
        and quality of life. The researchers are senior psychiatrists, all of whom received training
        on the use of questionnaires and inter-investigator consistency before the follow-up.
  
        Cox Proportional Hazard Model is used to analyze the influencing factors of remission of BPD,
        and Generalized Estimating Equation Model is used to analyze the influencing factors of the
        patients' social function and quality of life.
  observational model: Cohort
  time perspective: Other
  measure: remission rate
  time frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
  description: The remission rate is calculated as the number of patients who no longer met the diagnostic criteria for BPD for at least 6 months divided by the total number of enrolled patients. The diagnostic tool is ICD-10 (F60.3).
  measure: social disability
  time frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
  description: Social disability refers to the patient's occupation, family, social life, personal life and other aspects of functional deficits, using Social Disability Screening Schedule (SDSS) to assess.
  measure: quality of life
  time frame: After the first follow-up, patients will be followed up every 6 months, and the total follow-up time was 2 years.
  description: Someone's quality of life is the extent to which their life is comfortable or satisfying. The study used WHOQOL-BREF to assess patients' quality of life in the physical, psychological, social relationship, and environmental domains.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fan Yang, Master
  role: Study Director
  affiliation: Wuhan Mental Health Centre
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder