Study Stopped
human ressources
Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
LIMITOM
1 other identifier
interventional
10
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
June 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedMarch 23, 2022
March 1, 2022
2.4 years
May 22, 2019
March 8, 2022
Conditions
Keywords
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
EXPERIMENTALParticipating 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.
Social inclusion
ACTIVE COMPARATORParticipating at the cyberball game in inclusion condition in wich they will receive 33% of the throw : 10 in a total of 30
Interventions
a ball tossing playing game in which the experimentor can control the number of throws received by the participants
Eligibility Criteria
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
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: 28513343BACKGROUNDNemeth 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: 30248485BACKGROUNDWilliams 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: 16817529BACKGROUNDFonagy 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: 18312120BACKGROUNDStaebler 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: 21306661BACKGROUNDBazin 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: 19346006BACKGROUNDRoux 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul ROUX, MD PHD
Versailles Hospital
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