Borderline Personality DisorderLIMITOMNCT03968081
Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
A study testing Cyberball in people with Borderline Personality Disorder and Social Rejection, run by Versailles Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Social Rejection, Social Skills
- What is being tested?
- Cyberball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-V criteria for borderline personality disorder (Structured Clinical Interview for Disorders)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Borderline Personality Disorder, Social Rejection, Social Skills, Cognitive Function 1, Social
- Being tested
- Cyberball
- Keywords
- theory of mind, mentalisation, ostracism, cyberball
- Medical subject headings
- Borderline Personality Disorder, Social Isolation, Social Skills, Ostracism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberballBehavioural
a ball tossing playing game in which the experimentor can control the number of throws received by the participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Cyberball |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 56 repeated measures per subject, assessed during a 10 min long task
Secondary outcomes (3)
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.
Measured: One measure per subject, assessed during a 5 min long interview
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).
Measured: One measures per subject, assessed during a 20 min long interview
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).
Measured: One measures per subject, assessed during a 20 min long interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start26 Jun 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: human ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Paul ROUX, Versailles Hospital
- Investigators
- Paul ROUX, MD PHD, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968081
- Sponsor's protocol ID
- P18/12_LIMITOM
- Acronym
- LIMITOM
- Status last verified
- Mar 2022
- First submitted
- 22 May 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28513343Nemeth 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.
PubMed 30248485Williams 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.
PubMed 16817529Fonagy 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.
PubMed 18312120Staebler 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.
PubMed 21306661Bazin 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.
PubMed 19346006Roux 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.
PubMed 26836621
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03968081
- Acronym / sponsor ID
- LIMITOM / P18/12_LIMITOM
- Conditions
- Borderline Personality Disorder, Social Rejection, Social Skills, Cognitive Function 1, Social
- Keywords
- theory of mind, mentalisation, ostracism, cyberball
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: human ressources
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social exclusion | Experimental | Behavioral: CyberballParticipating 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 comparator | Behavioral: CyberballParticipating at the cyberball game in inclusion condition in wich they will receive 33% of the throw : 10 in a total of 30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-V criteria for borderline personality disorder (Structured Clinical Interview for Disorders)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyberballa ball tossing playing game in which the experimentor can control the number of throws received by the participants | Behavioural | Social exclusion, Social inclusion |
Primary outcome
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
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.
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.
3 secondary outcomes
Mentalization performance
Time frame: 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
Social rejection sensibility - difference between intentional and non intentional rejection
Time frame: One measures per subject, assessed during a 20 min long interview
Results and safety
The study was stopped early (reason given: human ressources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 28513343Savage 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.
- Background: PubMed 30248485Nemeth 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.
- Background: PubMed 16817529Williams 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.
- Background: PubMed 18312120Fonagy 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.
- Background: PubMed 21306661Staebler 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.
- Background: PubMed 19346006Bazin 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.
- Background: PubMed 26836621Roux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul ROUX, MD PHD principal investigator
Versailles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyberball in people with Borderline Personality Disorder and Social Rejection, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: human ressources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theory of mind performance (time frame: One measure per subject, assessed during a 30 min long task). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968081, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.