SOKO-1: Stress & Social Cognition in Borderline Personality Disorder

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT04504994

Collaborator

(none)

196

Enrollment

Location

Arms

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Behavioral: inclusion condition	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

196 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

empathy [30 minutes after cyberball]
Multifaceted Empathy Test

Secondary Outcome Measures

sharing behavior: amount of monetary units (max 30) shared with co-player [directly after cyberball]
Computer game

Other Outcome Measures

punishment behavior: number of accepted offers from co-player [15 minutes after cyberball]
Computer game

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

physical illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite University	Berlin		Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katja Wingenfeld, Principal Investigator, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT04504994

Other Study ID Numbers:

WI 3396/12-1

First Posted:

Aug 7, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Personality Disorders

Borderline Personality Disorder

Study Results

No Results Posted as of Mar 15, 2022