<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/NCT04504994</url>
  </required_header>
  <id_info>
    <org_study_id>WI 3396/12-1</org_study_id>
    <nct_id>NCT04504994</nct_id>
  </id_info>
  <brief_title>Stress &amp; Social Cognition in Borderline Personality Disorder</brief_title>
  <acronym>SOKO-1</acronym>
  <official_title>&quot;Fight-or-flight&quot; Versus &quot;Tend-and-befriend&quot; Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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 investigators will examine whether perceived social exclusion provoke a reduction in&#xD;
      prosocial behavior in BPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will examine whether perceived social exclusion provoke a reduction in&#xD;
      prosocial behavior, such as empathy, in BPD patients and whether this &quot;fight-or-flight&quot;&#xD;
      pattern is also seen in other relevant aspects of social behavior, such as sharing and&#xD;
      punishment behavior. To induce social exclusion all participants will play cyberball, either&#xD;
      the exclusion condition or the (over)inclusion condition before testing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>empathy</measure>
    <time_frame>30 minutes after cyberball</time_frame>
    <description>Multifaceted Empathy Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sharing behavior: amount of monetary units (max 30) shared with co-player</measure>
    <time_frame>directly after cyberball</time_frame>
    <description>Computer game</description>
  </secondary_outcome>
  <other_outcome>
    <measure>punishment behavior: number of accepted offers from co-player</measure>
    <time_frame>15 minutes after cyberball</time_frame>
    <description>Computer game</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>exclusion BPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cyberball exclusion condition - BPD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>over-inclusion BPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cyberball over-inclusion condition - BPD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exclusion healthy controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cyberball exclusion condition - healthy controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>over-inclusion healthy controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cyberball over-inclusion condition - healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>inclusion condition</intervention_name>
    <description>cyberball game: ex- versus over-inclusion condition</description>
    <arm_group_label>exclusion BPD</arm_group_label>
    <arm_group_label>exclusion healthy controls</arm_group_label>
    <arm_group_label>over-inclusion BPD</arm_group_label>
    <arm_group_label>over-inclusion healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        female patients with BPD and healthy control women, matched for age, body mass index, and&#xD;
        education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        physical illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charite University</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Katja Wingenfeld</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT04504994
org study id: WI 3396/12-1
nct id: NCT04504994
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will examine whether perceived social exclusion provoke a reduction in
      prosocial behavior in BPD patients.
The investigators will examine whether perceived social exclusion provoke a reduction in
      prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight"
      pattern is also seen in other relevant aspects of social behavior, such as sharing and
      punishment behavior. To induce social exclusion all participants will play cyberball, either
      the exclusion condition or the (over)inclusion condition before testing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: empathy
time frame: 30 minutes after cyberball
description: Multifaceted Empathy Test
measure: sharing behavior: amount of monetary units (max 30) shared with co-player
time frame: directly after cyberball
description: Computer game
measure: punishment behavior: number of accepted offers from co-player
time frame: 15 minutes after cyberball
description: Computer game
arm group label: exclusion BPD
arm group type: Experimental
description: cyberball exclusion condition - BPD patients
arm group label: over-inclusion BPD
arm group type: Experimental
description: cyberball over-inclusion condition - BPD patients
arm group label: exclusion healthy controls
arm group type: Experimental
description: cyberball exclusion condition - healthy controls
arm group label: over-inclusion healthy controls
arm group type: Experimental
description: cyberball over-inclusion condition - healthy controls
intervention type: Behavioral
intervention name: inclusion condition
description: cyberball game: ex- versus over-inclusion condition
arm group label: exclusion BPD
arm group label: exclusion healthy controls
arm group label: over-inclusion BPD
arm group label: over-inclusion healthy controls
criteria: 
gender: Female
gender based: Yes
gender description: female only
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Katja Wingenfeld
investigator title: Principal Investigator
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
sharing ipd: Undecided