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Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder (LIMITOM)

Primary Purpose

Borderline Personality Disorder, Social Rejection, Social Skills

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cyberball
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Borderline Personality Disorder focused on measuring theory of mind, mentalisation, ostracism, cyberball

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centre Hospitalier de Versailles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social exclusion

Social inclusion

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Mentalization performance
Total score on the 8 item reflexive questionary, a self report scale with 8 items (minimum 0, maximum 56) which measure the subject's mentalization abilities. A low outcome reflects low self evaluation of mentalizing skill, whereas a high outcome reflects high self evaluation of mentalizing skills.
Social rejection sensibility - intentional rejection
Using the VSISR which is a self-report scale including 20 items of intentional rejection and 20 match items of non intentional rejection, the subject will rate each one from 0 to 10 as a function of the anticipated suffering (0 for none, 10 for maximum suffering). The investigators will use intentional rejection score (minium 0 maximum 200).
Social rejection sensibility - difference between intentional and non intentional rejection
Using the VSISR which is a self-report scale including 20 items of intentional rejection and 20 match items of non intentional rejection, the subject will rate each one from 0 to 10 as a function of the anticipated suffering (0 for none, 10 for maximum suffering). The investigators will use difference between intentional and non intentional rejection score (minium 0 maximum 200).

Full Information

First Posted
May 22, 2019
Last Updated
March 8, 2022
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03968081
Brief Title
Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
Acronym
LIMITOM
Official Title
Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
human ressources
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
SAMPLING PLAN Existing data registration before the creation of data: As of the date of submission of this research plan for preregistration, the data have not yet been collected, created, or realized. Data collection procedures. Individuals with a borderline personality disorder will be recruited from community mental health centers. All participants will be naive to the purpose of the study, give informed consent in accordance with institutional guidelines and the Declaration of Helsinki. Sample size Maximum of 50 individuals with a borderline personality disorder. Given that psychometric properties of intention attribution measures by the VLIS in borderline personality disorder aren't known and the impact of social exclusion lead by a virtual ball-tossing game in intention's attribution aren't know either, it is impossible to operate a calculation of the number of necessary subjects. However, a previous study has shown that is was possible to prove a significant diminution of theory of mind measure in a group of 17 subjects with a borderline personality disorder, after being socially excluded by the cyberball. Because the measures used in this study are different from ours, the investigators offer to proceed with an intermediate analysis of power after including 10 subjects in each condition (social exclusion and inclusion). This power analysis aims to calculate the number of subjects the investigators should recruit for the difference underlined by our two intermediate samples to become significant. If this number exceeds 25 subjects in each group, the research will be stopped. DESIGN PLAN First, the investigators will collect socio-demographic data then the participants will have various evaluations and tests like the MADRS depression scale, the WAIS-IV with matrix reasoning, vocabulary and letter-number sequencing, an executive functions test (Test des commissions). Before playing the cyberball game the participants will perform the first sequence of intentional cartoon task, a computer task in which the subject had to choose a logical end at a 3 boxes comic strip, involving or not a human intention. Then they will play the cyberball game, a virtual ball-tossing game in which they are lead to think they are playing online with two other people while it is actually a randomized pre register condition. Following the VLIS, a theory of mind test in which the subject as to infer intentionality likehood for characters in various movies extracts. Then the second sequence of intentional cartoon task. They will finish with the the height items reflexive questionnaire and the VSISR (Versailles Sensitivity for Social Rejection, measuring social rejection sensitivity). ANALYSIS PLAN Comparison between groups : The groups' socio-demographic (age, sex, education), cognitive ( current IQ, and executive performance with planning and working memory) and mood (depression) characteristics will be compared using the Student t test or Χ² tests when appropriate. Only variables that significantly differ between the two groups will be included as covariates in the following analyses. The first analysis of covariance with repeated measures will be run with VLIS score as the dependent variable, the condition (social exclusion or inclusion) as the independent factor, and depression scale, and cognitive performances (matrix reasoning, vocabulary, letter-number sequencing, and executive functions test) as covariates. A second analysis of covariance with repeated measures will be run with intentional cartoon task score as the dependent variable, the condition (social exclusion or inclusion) as the independent between-subject factor, the time of measurement (before or after the cyberball) and the cartoon condition (intentional or non intentional) as the independent within-subject factors, and depression scale and cognitive performances (matrix reasoning, vocabulary, letter-number sequencing and executive functions test) as covariates. The third analysis of covariance with repeated measures will be run with questionnaire of reflexive functions score as the dependent variable, the condition (social exclusion or inclusion) as the independent factor and depression scale, and cognitive performances (matrix reasoning, vocabulary, letter-number sequencing, and executive functions test) as covariables Correlation analyses Spearman's correlation will be computed between: change in intentional cartoon task score after social exclusion and VSISR intentional cartoon task score and questionnaire of reflexive functions score VLIS score and questionnaire of reflexive functions score Missing data management : The investigators predict an anecdotal quantity of missing data (<5%) in our study. If need be the investigators will exclude them.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Social Rejection, Social Skills, Cognitive Function 1, Social
Keywords
theory of mind, mentalisation, ostracism, cyberball

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social exclusion
Arm Type
Experimental
Arm Description
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.
Arm Title
Social inclusion
Arm Type
Active Comparator
Arm Description
Participating at the cyberball game in inclusion condition in wich they will receive 33% of the throw : 10 in a total of 30
Intervention Type
Behavioral
Intervention Name(s)
Cyberball
Intervention Description
a ball tossing playing game in which the experimentor can control the number of throws received by the participants
Primary Outcome Measure Information:
Title
Theory of mind performance
Description
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
Time Frame
One measure per subject, assessed during a 30 min long task
Title
Evolution of theory of mind performance after cyberball - accuracy
Description
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.
Time Frame
56 repeated measures per subject, assessed during a 10 min long task
Title
Evolution of theory of mind performance after cyberball - reaction time
Description
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.
Time Frame
56 repeated measures per subject, assessed during a 10 min long task
Secondary Outcome Measure Information:
Title
Mentalization performance
Description
Total score on the 8 item reflexive questionary, a self report scale with 8 items (minimum 0, maximum 56) which measure the subject's mentalization abilities. A low outcome reflects low self evaluation of mentalizing skill, whereas a high outcome reflects high self evaluation of mentalizing skills.
Time Frame
One measure per subject, assessed during a 5 min long interview
Title
Social rejection sensibility - intentional rejection
Description
Using the VSISR which is a self-report scale including 20 items of intentional rejection and 20 match items of non intentional rejection, the subject will rate each one from 0 to 10 as a function of the anticipated suffering (0 for none, 10 for maximum suffering). The investigators will use intentional rejection score (minium 0 maximum 200).
Time Frame
One measures per subject, assessed during a 20 min long interview
Title
Social rejection sensibility - difference between intentional and non intentional rejection
Description
Using the VSISR which is a self-report scale including 20 items of intentional rejection and 20 match items of non intentional rejection, the subject will rate each one from 0 to 10 as a function of the anticipated suffering (0 for none, 10 for maximum suffering). The investigators will use difference between intentional and non intentional rejection score (minium 0 maximum 200).
Time Frame
One measures per subject, assessed during a 20 min long interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-V criteria for borderline personality disorder (Structured Clinical Interview for Disorders) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul ROUX, MD PHD
Organizational Affiliation
Versailles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28513343
Citation
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.
Results Reference
background
PubMed Identifier
30248485
Citation
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.
Results Reference
background
PubMed Identifier
16817529
Citation
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.
Results Reference
background
PubMed Identifier
18312120
Citation
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.
Results Reference
background
PubMed Identifier
21306661
Citation
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.
Results Reference
background
PubMed Identifier
19346006
Citation
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.
Results Reference
background
PubMed Identifier
26836621
Citation
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.
Results Reference
background

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Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder

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