Stress & Social Cognition in Borderline Personality Disorder | NCT04504994

Studies
Stress & Social Cognition in Borderline Personality Disorder

NCT04504994

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 15, 2022Actual

Enrollment

196Actual

Phase

Not Applicable

Conditions

Borderline Personality Disorder

Interventions

inclusion condition

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Jul 30, 2020

First Submission Date that Met QC Criteria

Aug 5, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

196Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exclusion BPD	Experimental	cyberball exclusion condition - BPD patients	Behavioral: inclusion condition
over-inclusion BPD	Experimental	cyberball over-inclusion condition - BPD patients	Behavioral: inclusion condition
exclusion healthy controls	Experimental	cyberball exclusion condition - healthy controls	Behavioral: inclusion condition
over-inclusion healthy controls	Experimental	cyberball over-inclusion condition - healthy controls	Behavioral: inclusion condition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inclusion condition	Behavioral	cyberball game: ex- versus over-inclusion condition	exclusion BPD exclusion healthy controls over-inclusion BPD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

physical illness

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female only

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided