NCT03968081

Brief Summary

Theory of mind is one of the features of mentalization. It can be defined as the ability to predict or explain other's behavior with the assignment of beliefs, wishes, and intentions and knowing how to discriminate them with our own, or in other words to know how other people think. Although this ability is crucial to behave adequately in a complex environment, theory of mind judgments are not always optimal. Notably, individuals with borderline personality disorder are may have difficulties to infer other people's thought and state of mind as well as their own mental states. These aspects could be at the origin of symptoms like impaired and unstable relationships, identity disruption and excessive fear of abandonment. Clinical and scientific point suggest that this struggle can be reinforced by social exclusion. Our study aims at identifying if a situation of social exclusion (compared with social inclusion) may decrease theory of mind performance in borderline personality disorder. Participants will play a virtual ball-tossing game on a computer, which can lead to a situation of social inclusion or exclusion. Before and after that, they will perform theory of mind tests with visual material. The study will address three research questions: Q1: Is theory of mind performance lowered after social exclusion, compared with social inclusion? Q2: is the self-reported mentalization skills correlated with theory of mind performances? Q3: Is the social rejection sensitivity correlated with the the theory of mind performances ? The investigators make several hypotheses related to the previous research questions: Q1: the investigators expect social exclusion will decrease the subject's theory of mind performances. Q2: the investigators expect low mentalization skills are correlated to low theory of mind performances. Q3: the investigators expect that a high social rejection sensitivity will be correlated with low theory of mind performances.

Trial Health

57
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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

May 22, 2019

Last Update Submit

March 8, 2022

Conditions

Keywords

theory of mindmentalisationostracismcyberball

Outcome Measures

Primary Outcomes (3)

  • Theory of mind performance

    Total score at the VLIS (Versailles intentional reading in situation), minimum 0, maximum 90, a low outcome indicate high theory of mind performances whereas a high score indicate low theory of mind performances. Accuracy and reaction time at the intentional cartoon task

    One measure per subject, assessed during a 30 min long task

  • Evolution of theory of mind performance after cyberball - accuracy

    Accuracy (percentage minium 0 maximum 100) in the intentional cartoon task : a computer task in wich the subjects have to choose the logical end of comic strip involving or not human intention. There is 28 comic strip in each of the two sessions.

    56 repeated measures per subject, assessed during a 10 min long task

  • Evolution of theory of mind performance after cyberball - reaction time

    Reaction time (milliseconds, minimum 100 milliseconds maximum 4000 milliseconds) in the intentional cartoon task : a computer task in wich the subjects have to choose the logical end of comic strip involving or not human intention. There is 28 comic strip in each of the two sessions.

    56 repeated measures per subject, assessed during a 10 min long task

Secondary Outcomes (3)

  • Mentalization performance

    One measure per subject, assessed during a 5 min long interview

  • Social rejection sensibility - intentional rejection

    One measures per subject, assessed during a 20 min long interview

  • Social rejection sensibility - difference between intentional and non intentional rejection

    One measures per subject, assessed during a 20 min long interview

Study Arms (2)

Social exclusion

EXPERIMENTAL

Participating at the cyberball game in exclusion condition in wich they will receive 2 time the ball in the 10 first throw then none of them in the last 20 throw.

Behavioral: Cyberball

Social inclusion

ACTIVE COMPARATOR

Participating at the cyberball game in inclusion condition in wich they will receive 33% of the throw : 10 in a total of 30

Behavioral: Cyberball

Interventions

CyberballBEHAVIORAL

a ball tossing playing game in which the experimentor can control the number of throws received by the participants

Social exclusionSocial inclusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-V criteria for borderline personality disorder (Structured Clinical Interview for Disorders)

You may not qualify if:

  • Criteria of DSM-V substance use disorder from moderate to severe (except for tobacco and caffeine) in the last six months
  • schizophrenic disorder
  • Bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

Related Publications (7)

  • Savage M, Lenzenweger MF. The Impact of Social Exclusion on "Reading the Mind in the Eyes" Performance in Relation to Borderline Personality Disorder Features. J Pers Disord. 2018 Feb;32(1):109-130. doi: 10.1521/pedi_2017_31_293. Epub 2017 May 17.

    PMID: 28513343BACKGROUND
  • Nemeth N, Matrai P, Hegyi P, Czeh B, Czopf L, Hussain A, Pammer J, Szabo I, Solymar M, Kiss L, Hartmann P, Szilagyi AL, Kiss Z, Simon M. Theory of mind disturbances in borderline personality disorder: A meta-analysis. Psychiatry Res. 2018 Dec;270:143-153. doi: 10.1016/j.psychres.2018.08.049. Epub 2018 Sep 21.

    PMID: 30248485BACKGROUND
  • Williams KD, Jarvis B. Cyberball: a program for use in research on interpersonal ostracism and acceptance. Behav Res Methods. 2006 Feb;38(1):174-80. doi: 10.3758/bf03192765.

    PMID: 16817529BACKGROUND
  • Fonagy P, Bateman A. The development of borderline personality disorder--a mentalizing model. J Pers Disord. 2008 Feb;22(1):4-21. doi: 10.1521/pedi.2008.22.1.4.

    PMID: 18312120BACKGROUND
  • Staebler K, Renneberg B, Stopsack M, Fiedler P, Weiler M, Roepke S. Facial emotional expression in reaction to social exclusion in borderline personality disorder. Psychol Med. 2011 Sep;41(9):1929-38. doi: 10.1017/S0033291711000080. Epub 2011 Feb 9.

    PMID: 21306661BACKGROUND
  • Bazin N, Brunet-Gouet E, Bourdet C, Kayser N, Falissard B, Hardy-Bayle MC, Passerieux C. Quantitative assessment of attribution of intentions to others in schizophrenia using an ecological video-based task: a comparison with manic and depressed patients. Psychiatry Res. 2009 May 15;167(1-2):28-35. doi: 10.1016/j.psychres.2007.12.010. Epub 2009 Apr 5.

    PMID: 19346006BACKGROUND
  • Roux P, Brunet-Gouet E, Passerieux C, Ramus F. Eye-tracking reveals a slowdown of social context processing during intention attribution in patients with schizophrenia. J Psychiatry Neurosci. 2016 Mar;41(2):E13-21. doi: 10.1503/jpn.150045.

    PMID: 26836621BACKGROUND

MeSH Terms

Conditions

Borderline Personality DisorderSocial IsolationSocial SkillsOstracism

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Paul ROUX, MD PHD

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 30, 2019

Study Start

June 26, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations