<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/NCT03018639</url>
  </required_header>
  <id_info>
    <org_study_id>DBT_dropout</org_study_id>
    <nct_id>NCT03018639</nct_id>
  </id_info>
  <brief_title>Impact of Therapist Change on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving DBT</brief_title>
  <official_title>Impact of Therapist Change After Initial Contact and Traumatic Burden on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving Dialectical Behavior Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evangelisches Krankenhaus Bielefeld gGmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Evangelisches Krankenhaus Bielefeld gGmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient&#xD;
      Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set&#xD;
      assessing demographic information and pretreatment psychopathology during the days of their&#xD;
      inpatient stay. Beyond that, changes of therapists were documented.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dropout</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">89</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <condition>PostTraumatic Stress Disorder</condition>
  <condition>Psychotherapy</condition>
  <condition>Dropout</condition>
  <arm_group>
    <arm_group_label>Dialectical Behavior Therapy</arm_group_label>
    <description>The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialectical Behavior Therapy</intervention_name>
    <description>DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).</description>
    <arm_group_label>Dialectical Behavior Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For this study, all patients aged from 18 to 65, discharged from our personality disorder&#xD;
        inpatient unit between December 2012 and August 2016, and fulfilling three or more criteria&#xD;
        for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered&#xD;
        (n = 89).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  three or more criteria for BPD as defined by DSM-IV (Borderline Personality&#xD;
             characteristics; BPC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to contract and consent,&#xD;
&#xD;
          -  other severe mental disorders (bipolar disorder, acute psychosis),&#xD;
&#xD;
          -  current alcohol,&#xD;
&#xD;
          -  illicit or not prescribed drug use,&#xD;
&#xD;
          -  simultaneous participation in other treatment studies,&#xD;
&#xD;
          -  pregnancy or breastfeeding,&#xD;
&#xD;
          -  an inability to negotiate a non-suicide agreement,&#xD;
&#xD;
          -  ongoing traumatic contact with the perpetrator, and&#xD;
&#xD;
          -  a Body Mass Index &lt; 16.5.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Driessen</last_name>
    <role>Study Director</role>
    <affiliation>Research Department, Ev. Krankenhaus Bielefeld</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Department</name>
      <address>
        <city>Bielefeld</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Evangelisches Krankenhaus Bielefeld gGmbH</investigator_affiliation>
    <investigator_full_name>Carolin Steuwe</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03018639
org study id: DBT_dropout
nct id: NCT03018639
lead sponsor: 
has dmc: No
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient
      Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set
      assessing demographic information and pretreatment psychopathology during the days of their
      inpatient stay. Beyond that, changes of therapists were documented.
observational model: Case-Only
time perspective: Prospective
measure: Dropout
time frame: 10 weeks
arm group label: Dialectical Behavior Therapy
description: The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD.
intervention type: Behavioral
intervention name: Dialectical Behavior Therapy
description: DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
arm group label: Dialectical Behavior Therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Martin Driessen
role: Study Director
affiliation: Research Department, Ev. Krankenhaus Bielefeld
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Evangelisches Krankenhaus Bielefeld gGmbH
investigator full name: Carolin Steuwe
investigator title: Research Associate
mesh term: Stress Disorders, Post-Traumatic
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: No