Stress & Social Cognition in Borderline Personality Disorder (SOKO-1)

March 14, 2022 updated by: Katja Wingenfeld, Charite University, Berlin, Germany

"Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I

The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

female patients with BPD and healthy control women, matched for age, body mass index, and education

Exclusion Criteria:

physical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: exclusion BPD
cyberball exclusion condition - BPD patients
Behavioral: inclusion condition
cyberball game: ex- versus over-inclusion condition
EXPERIMENTAL: over-inclusion BPD
cyberball over-inclusion condition - BPD patients
Behavioral: inclusion condition
cyberball game: ex- versus over-inclusion condition
EXPERIMENTAL: exclusion healthy controls
cyberball exclusion condition - healthy controls
Behavioral: inclusion condition
cyberball game: ex- versus over-inclusion condition
EXPERIMENTAL: over-inclusion healthy controls
cyberball over-inclusion condition - healthy controls
Behavioral: inclusion condition
cyberball game: ex- versus over-inclusion condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
empathy
Time Frame: 30 minutes after cyberball
Multifaceted Empathy Test
30 minutes after cyberball

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sharing behavior: amount of monetary units (max 30) shared with co-player
Time Frame: directly after cyberball
Computer game
directly after cyberball

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
punishment behavior: number of accepted offers from co-player
Time Frame: 15 minutes after cyberball
Computer game
15 minutes after cyberball

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI 3396/12-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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