<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/NCT03297840</url>
  </required_header>
  <id_info>
    <org_study_id>Mindfullness in BPD</org_study_id>
    <nct_id>NCT03297840</nct_id>
  </id_info>
  <brief_title>Change in Mindfulness in Borderline Personality Disorder</brief_title>
  <official_title>Change in Mindfulness in Borderline Personality Disorder After Dialectic-behavioural Therapy (DBT): A Pre-post-comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Katharina Bachmann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oldenburg</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>
      The current study aims to investigate the effect of dialectical behavioral therapy on&#xD;
      mindfulness in patients with Borderline Personality Disorder. A treatment group will be&#xD;
      compared to a waitlist control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited from the Dialectical-Behavioral-Therapy (DBT) unit. DBT is a&#xD;
      treatment approach that has been shown to be effective in the treatment of Borderline&#xD;
      Personality Disorder. DBT integrates different psychotherapeutic interventions as well as&#xD;
      Mindfulness Meditation exercises. Mindfulness is a meditation practice that can improve&#xD;
      present moment awareness. When applied as therapeutic intervention mindfulness meditation can&#xD;
      help patients to stay with their attention in the present moment, to be aware what is&#xD;
      happening in the here and now, and to better identify and regulate upcoming emotions.&#xD;
&#xD;
      The current observational study investigates changes in symptom severity and mindfulness&#xD;
      skills during DBT treatment. A treatment group will be compared to a waitlist control group.&#xD;
      The two groups are predefined by routine medical care.&#xD;
&#xD;
      Symptom severity and mindfulness skills will be assessed at baseline (before treatment or&#xD;
      when accepted for the waitlist) and after 12-weeks. A within and between group analyses will&#xD;
      be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mindfulness</measure>
    <time_frame>Baseline and after 12-weeks</time_frame>
    <description>Degree of mindfulness will be assessed by the Kentucky Inventory of Mindfulness Skills, German Version (KIMS-D). A within and between group comparison will be performed (treatment vs. waitlist).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in borderline symptom severity</measure>
    <time_frame>Baseline and after 12-weeks</time_frame>
    <description>Change in Borderline symptom severity is measured by the Borderline Symptom List (BSL 23). A within and between group comparison will be performed (treatment vs. waitlist).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in overall psychiatric symptom severity</measure>
    <time_frame>Baseline and after 12-weeks</time_frame>
    <description>Change in overall symptom severity is measured by the Change in symptomseverity is measured by the Symptom-Checklist-90®-Standard (SCL-90). A within and between group comparison will be performed (treatment vs. waitlist).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in severity in symptoms of depression</measure>
    <time_frame>Baseline and after 12-weeks</time_frame>
    <description>Change in overall symptom severity is measured by the Beck depression inventory (BDI). A within and between group comparison will be performed (treatment vs. waitlist).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Mindfulness</condition>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>Patients with Borderline Personality Disorder receiving DBT treatment. Measurement takes place at the beginning of the treatment and a second time after 12-weeks treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <description>Patients with Borderline Personality Disorder on the waitlist for inpatient DBT treatment. Measurement takes place twice at baseline and after 12-weeks waiting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialectical Behavioural Therapy (DBT)</intervention_name>
    <description>Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female BPD Patients from 18 to 60 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Borderline Personality Disorder&#xD;
&#xD;
          -  On the waitlist for DBT treatment or actually treated with DBT&#xD;
&#xD;
          -  Not previously treated with DBT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra Philipsen, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katharina Bachmann, Psych.Msc.</last_name>
    <phone>00494119615 1506</phone>
    <email>Katharina.Bachmann@uni-oldenburg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg</name>
      <address>
        <city>Bad Zwischenahn</city>
        <zip>26160</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katharina Bachmann, Psych.Msc.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Oldenburg</investigator_affiliation>
    <investigator_full_name>Katharina Bachmann</investigator_full_name>
    <investigator_title>Psychologist Msc.</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03297840
org study id: Mindfullness in BPD
nct id: NCT03297840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study aims to investigate the effect of dialectical behavioral therapy on
      mindfulness in patients with Borderline Personality Disorder. A treatment group will be
      compared to a waitlist control group.
Participants will be recruited from the Dialectical-Behavioral-Therapy (DBT) unit. DBT is a
      treatment approach that has been shown to be effective in the treatment of Borderline
      Personality Disorder. DBT integrates different psychotherapeutic interventions as well as
      Mindfulness Meditation exercises. Mindfulness is a meditation practice that can improve
      present moment awareness. When applied as therapeutic intervention mindfulness meditation can
      help patients to stay with their attention in the present moment, to be aware what is
      happening in the here and now, and to better identify and regulate upcoming emotions.

      The current observational study investigates changes in symptom severity and mindfulness
      skills during DBT treatment. A treatment group will be compared to a waitlist control group.
      The two groups are predefined by routine medical care.

      Symptom severity and mindfulness skills will be assessed at baseline (before treatment or
      when accepted for the waitlist) and after 12-weeks. A within and between group analyses will
      be performed.
observational model: Other
time perspective: Other
measure: Change in mindfulness
time frame: Baseline and after 12-weeks
description: Degree of mindfulness will be assessed by the Kentucky Inventory of Mindfulness Skills, German Version (KIMS-D). A within and between group comparison will be performed (treatment vs. waitlist).
measure: Change in borderline symptom severity
time frame: Baseline and after 12-weeks
description: Change in Borderline symptom severity is measured by the Borderline Symptom List (BSL 23). A within and between group comparison will be performed (treatment vs. waitlist).
measure: Change in overall psychiatric symptom severity
time frame: Baseline and after 12-weeks
description: Change in overall symptom severity is measured by the Change in symptomseverity is measured by the Symptom-Checklist-90®-Standard (SCL-90). A within and between group comparison will be performed (treatment vs. waitlist).
measure: Change in severity in symptoms of depression
time frame: Baseline and after 12-weeks
description: Change in overall symptom severity is measured by the Beck depression inventory (BDI). A within and between group comparison will be performed (treatment vs. waitlist).
arm group label: Treatment
description: Patients with Borderline Personality Disorder receiving DBT treatment. Measurement takes place at the beginning of the treatment and a second time after 12-weeks treatment.
arm group label: Waitlist
description: Patients with Borderline Personality Disorder on the waitlist for inpatient DBT treatment. Measurement takes place twice at baseline and after 12-weeks waiting.
intervention type: Behavioral
intervention name: Dialectical Behavioural Therapy (DBT)
description: Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.
arm group label: Treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Alexandra Philipsen, Prof.
role: Principal Investigator
affiliation: Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany
last name: Katharina Bachmann, Psych.Msc.
phone: 00494119615 1506
email: Katharina.Bachmann@uni-oldenburg.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Oldenburg
investigator full name: Katharina Bachmann
investigator title: Psychologist Msc.
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: Undecided