跳至主要内容
临床试验/NCT03968081
NCT03968081终止不适用

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

Versailles Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
1
主要终点
Theory of mind performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Cyberball (Behavioral)

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

干预措施: Cyberball (Behavioral)

结局指标

主要结局

Theory of mind performance

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Social rejection sensibility - difference between intentional and non intentional rejection(One measures per subject, assessed during a 20 min long interview)
  • 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)

研究者

发起方
Versailles Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Paul ROUX

Principal Investigator

Versailles Hospital

研究点 (1)

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