Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
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
- 否
入选标准
- •To be over 18
- •Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-Text Reviewed Axis II Personality Disorders)
- •Having signed the informed consent
- •Able to understand the nature, the purpose and the methodology of the study
- •Able to understand and perform the clinical evaluations
排除标准
- •Deprived of liberty (by judicial or administrative decision)
- •Protected by law (guardianship)
- •Exclusion period in relation to another protocol
- •Not affiliated to a social security scheme
研究组 & 干预措施
Patients with Borderline Personality Disorder
At each visit, these patients will have an interview that will allow for a clinical evaluation, as well as completing the hetero-questionnaires and self-questionnaires
干预措施: Clinical and biological assessments - a 5 Years follow-up (Other)
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
Level of shame propensity
时间窗: At enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
时间窗: 1 year after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
时间窗: 2 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
时间窗: 3 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
时间窗: 4 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: At enrollment
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
时间窗: 1 year 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
Number of SA compared to the clinical data obtained in baseline
时间窗: 2 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
Number of SA compared to the clinical data obtained in baseline
时间窗: 3 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
Number of SA compared to the clinical data obtained in baseline
时间窗: 4 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)
- Hospitalization for a psychiatric condition(5 years after enrollment)
- The need to emergency psychiatric consult(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)
- Number of SA compared to the biological data obtained in baseline(At enrollment)
- Number of SA compared to the biological data obtained in baseline(1 year after enrollment)
- Number of SA compared to the biological data obtained in baseline(2 years after enrollment)
- Number of SA compared to the biological data obtained in baseline(3 years after enrollment)
- Number of SA compared to the biological data obtained in baseline(4 years after enrollment)
- Suicidal Ideation(At enrollment)
- Suicidal Ideation(1 year after enrollment)
- Suicidal Ideation(2 years after enrollment)
- Suicidal Ideation(3 years after enrollment)
- Suicidal Ideation(4 years after enrollment)
- Parasuicidal Behaviours(At enrollment)
- Parasuicidal Behaviours(1 year after enrollment)
- Parasuicidal Behaviours(2 years after enrollment)
- Parasuicidal Behaviours(3 years after enrollment)
- Parasuicidal Behaviours(4 years after enrollment)
- Sick leave for a psychiatric condition(At enrollment)
- Sick leave for a psychiatric condition(1 year after enrollment)
- Sick leave for a psychiatric condition(2 years after enrollment)
- Sick leave for a psychiatric condition(3 years after enrollment)
- Sick leave for a psychiatric condition(4 years after enrollment)
- Hospitalization for a psychiatric condition(At enrollment)
- Hospitalization for a psychiatric condition(1 year after enrollment)
- Hospitalization for a psychiatric condition(2 years after enrollment)
- Hospitalization for a psychiatric condition(3 years after enrollment)
- Hospitalization for a psychiatric condition(4 years after enrollment)
- The need to emergency psychiatric consult(At enrollment)
- The need to emergency psychiatric consult(1 year after enrollment)
- The need to emergency psychiatric consult(2 years after enrollment)
- The need to emergency psychiatric consult(3 years after enrollment)
- The need to emergency psychiatric consult(4 years after enrollment)
- Major depressive episodes(At enrollment)
- Major depressive episodes(1 year after enrollment)
- Major depressive episodes(2 years after enrollment)
- Major depressive episodes(3 years after enrollment)
- Major depressive episodes(4 years after enrollment)
- Global functioning(At enrollment)
- Global functioning(1 year after enrollment)
- Global functioning(2 years after enrollment)
- Global functioning(3 years after enrollment)
- Global functioning(4 years after enrollment)
- Life Quality(At enrollment)
- Life Quality(1 year after enrollment)
- Life Quality(2 years after enrollment)
- Life Quality(3 years after enrollment)
- Life Quality(4 years after enrollment)