Back to resultsStress & Social Cognition in Borderline Personality Disorder (SOKO-1)
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
inclusion condition
Sponsored by
About this trial
This is an interventional basic science trial for Borderline Personality Disorder
Eligibility Criteria
Inclusion Criteria:
female patients with BPD and healthy control women, matched for age, body mass index, and education
Exclusion Criteria:
physical illness
Sites / Locations
- Charite University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
exclusion BPD
over-inclusion BPD
exclusion healthy controls
over-inclusion healthy controls
Arm Description
cyberball exclusion condition - BPD patients
cyberball over-inclusion condition - BPD patients
cyberball exclusion condition - healthy controls
cyberball over-inclusion condition - healthy controls
Outcomes
Primary Outcome Measures
empathy
Multifaceted Empathy Test
Secondary Outcome Measures
sharing behavior: amount of monetary units (max 30) shared with co-player
Computer game
Full Information
NCT ID
NCT04504994
First Posted
July 30, 2020
Last Updated
March 14, 2022
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT04504994
Brief Title
Stress & Social Cognition in Borderline Personality Disorder
Acronym
SOKO-1
Official Title
"Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exclusion BPD
Arm Type
Experimental
Arm Description
cyberball exclusion condition - BPD patients
Arm Title
over-inclusion BPD
Arm Type
Experimental
Arm Description
cyberball over-inclusion condition - BPD patients
Arm Title
exclusion healthy controls
Arm Type
Experimental
Arm Description
cyberball exclusion condition - healthy controls
Arm Title
over-inclusion healthy controls
Arm Type
Experimental
Arm Description
cyberball over-inclusion condition - healthy controls
Intervention Type
Behavioral
Intervention Name(s)
inclusion condition
Intervention Description
cyberball game: ex- versus over-inclusion condition
Primary Outcome Measure Information:
Title
empathy
Description
Multifaceted Empathy Test
Time Frame
30 minutes after cyberball
Secondary Outcome Measure Information:
Title
sharing behavior: amount of monetary units (max 30) shared with co-player
Description
Computer game
Time Frame
directly after cyberball
Other Pre-specified Outcome Measures:
Title
punishment behavior: number of accepted offers from co-player
Description
Computer game
Time Frame
15 minutes after cyberball
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients with BPD and healthy control women, matched for age, body mass index, and education
Exclusion Criteria:
physical illness
Facility Information:
Facility Name
Charite University
City
Berlin
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Stress & Social Cognition in Borderline Personality Disorder
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