NCT04504994

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

July 30, 2020

Last Update Submit

March 14, 2022

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • empathy

    Multifaceted Empathy Test

    30 minutes after cyberball

Secondary Outcomes (1)

  • sharing behavior: amount of monetary units (max 30) shared with co-player

    directly after cyberball

Other Outcomes (1)

  • punishment behavior: number of accepted offers from co-player

    15 minutes after cyberball

Study Arms (4)

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

inclusion conditionBEHAVIORAL

cyberball game: ex- versus over-inclusion condition

exclusion BPDexclusion healthy controlsover-inclusion BPDover-inclusion healthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • physical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 7, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

DE(1)