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

March 8, 2022 updated by: Dr Paul ROUX, Versailles Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150
        • Centre Hospitalier De Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Social exclusion
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
a ball tossing playing game in which the experimentor can control the number of throws received by the participants
Active Comparator: Social inclusion
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
a ball tossing playing game in which the experimentor can control the number of throws received by the participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theory of mind performance
Time Frame: One measure per subject, assessed during a 30 min long task

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
Time Frame: 56 repeated measures per subject, assessed during a 10 min long task
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
Time Frame: 56 repeated measures per subject, assessed during a 10 min long task
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mentalization performance
Time Frame: One measure per subject, assessed during a 5 min long interview

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.
One measure per subject, assessed during a 5 min long interview
Social rejection sensibility - intentional rejection
Time Frame: One measures per subject, assessed during a 20 min long interview

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).
One measures per subject, assessed during a 20 min long interview
Social rejection sensibility - difference between intentional and non intentional rejection
Time Frame: One measures per subject, assessed during a 20 min long interview

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2019

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P18/12_LIMITOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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