跳至主要内容
临床试验/NCT03994510
NCT03994510招募中不适用

Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 688 人开始时间: 2020年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
688
试验地点
2
主要终点
Level of shame propensity

研究概览

简要总结

Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.

Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.

The main objective is to study the propensity to feel shame as a predictor of SA.

This include:

  • Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.
  • Identify biological markers predicting SA
  • Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA

详细描述

This is a 5 years follow-up prospective study recruiting 688 patients.

Schedule of the study :

Inclusion period : 3 years Duration of follow-up of each patient : 5 years Estimated duration of the study : 8.5 years

As part of the research, patients will be summoned annually for 5 years.

The first visit (at baseline) is included in the usual care

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Level of shame propensity

时间窗: 5 years after enrollment

Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

Number of SA compared to the clinical data obtained in baseline

时间窗: 5 years after enrollment

The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline

次要结局

  • Parasuicidal Behaviours(5 years after enrollment)
  • Sick leave for a psychiatric condition(5 years after enrollment)
  • Major depressive episodes(5 years after enrollment)
  • The need to emergency psychiatric consult(5 years after enrollment)
  • Hospitalization for a psychiatric condition(5 years after enrollment)
  • Global functioning(5 years after enrollment)
  • Suicidal Ideation(5 years after enrollment)
  • Life Quality(5 years after enrollment)
  • Number of SA compared to the biological data obtained in baseline(5 years after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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