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/NCT06005129</url>
    </required_header>
    <id_info>
      <org_study_id>86801</org_study_id>
      <nct_id>NCT06005129</nct_id>
    </id_info>
    <brief_title>Personality Change Study for Borderline Personality Disorder</brief_title>
    <official_title>Engaging Higher-Order Mechanisms of Psychopathology: A Parsimonious Approach to Precision Medicine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shannon E. Sauer-Zavala</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Psychological Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Kentucky</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>
        Participants with borderline personality disorder will undergo an a 2 - 4 week baseline&#xD;
        assessment to determine level of outcomes of interest in the absence of treatment. After the&#xD;
        baseline period, participants will receive six weekly 50-60-minute treatment sessions. After&#xD;
        the 6 treatment sessions, participants will complete a 4-week follow-up period to determine&#xD;
        the sustainability of the treatment module.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>N/A</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in clinician-rated borderline personality disorder symptoms</measure>
      <time_frame>up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)</time_frame>
      <description>Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - clinician-rated version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in patient-reported borderline personality disorder symptoms</measure>
      <time_frame>weekly up to 14 weeks</time_frame>
      <description>Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - self-report version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Borderline Personality Disorder</condition>
    <arm_group>
      <arm_group_label>Personality-based treatment 2 week baseline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Personality-based treatment 4 week baseline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Personality-Based Therapy</intervention_name>
      <description>Participants will be randomized to a 2- or 4-week assessment-only baseline period. After the baseline period, participants will receive the personality-based treatment module corresponding to their highest clinical elevation (i.e., neuroticism, [low] conscientiousness, [low] agreeableness). Treatment will consist of six weekly 50-60-minute sessions. After the 6-week intervention period, participants will complete a 4-week follow-up period to determine the sustainability of effects observed</description>
      <arm_group_label>Personality-based treatment 2 week baseline</arm_group_label>
      <arm_group_label>Personality-based treatment 4 week baseline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Speak English fluently&#xD;
  &#xD;
            -  Diagnosis of Borderline Personality Disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosed psychological conditions that would be better addressed by alternative&#xD;
               treatments&#xD;
  &#xD;
            -  concurrent psychotherapy&#xD;
  &#xD;
            -  medication instability&#xD;
  &#xD;
            -  substance use disorder&#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_official>
      <last_name>Shannon Sauer-Zavala, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shannon Sauer-Zavala, PhD</last_name>
      <phone>(859) 562-1570</phone>
      <email>tipslab@uky.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinic for Emotional Health at the University of Kentucky</name>
        <address>
          <city>Lexington</city>
          <state>Kentucky</state>
          <zip>40508-2307</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shannon E Sauer-Zavala</last_name>
        <phone>859-562-1570</phone>
        <email>tipslab@uky.ed</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Shannon E. Sauer-Zavala</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>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/NCT06005129
  org study id: 86801
  nct id: NCT06005129
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Participants with borderline personality disorder will undergo an a 2 - 4 week baseline
        assessment to determine level of outcomes of interest in the absence of treatment. After the
        baseline period, participants will receive six weekly 50-60-minute treatment sessions. After
        the 6 treatment sessions, participants will complete a 4-week follow-up period to determine
        the sustainability of the treatment module.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in clinician-rated borderline personality disorder symptoms
  time frame: up to 14 weeks (pre-baseline, pre-intervention, post-intervention, post-follow-up)
  description: Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - clinician-rated version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms
  measure: Change in patient-reported borderline personality disorder symptoms
  time frame: weekly up to 14 weeks
  description: Change in borderline personality disorder symptoms will be measured using Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) - self-report version. Scores range from 0-36; higher scores indicate greater severity of borderline personality disorder symptoms
  arm group label: Personality-based treatment 2 week baseline
  arm group type: Experimental
  description: Participants will receive treatment tailored to 1 of 3 personality dimensions after a 2 week baseline assessment
  arm group label: Personality-based treatment 4 week baseline
  arm group type: Experimental
  description: Participants will receive treatment tailored to 1 of 3 personality dimensions after a 4 week baseline assessment
  intervention type: Behavioral
  intervention name: Personality-Based Therapy
  description: Participants will be randomized to a 2- or 4-week assessment-only baseline period. After the baseline period, participants will receive the personality-based treatment module corresponding to their highest clinical elevation (i.e., neuroticism, [low] conscientiousness, [low] agreeableness). Treatment will consist of six weekly 50-60-minute sessions. After the 6-week intervention period, participants will complete a 4-week follow-up period to determine the sustainability of effects observed
  arm group label: Personality-based treatment 2 week baseline
  arm group label: Personality-based treatment 4 week baseline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shannon Sauer-Zavala, PhD
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Shannon Sauer-Zavala, PhD
  phone: (859) 562-1570
  email: tipslab@uky.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Shannon E. Sauer-Zavala
  investigator title: Associate Professor
  mesh term: Personality Disorders
  mesh term: Borderline Personality Disorder