SHame prOpensity in bOrderline Personality Disorder

Study Overview
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Brief Summary
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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

Detailed Description
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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 The follow-up visits are specifics to the research During the visits patients will complete self questionary and clinical interview. The organization of visits is as follows: an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires) a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires) Genetic samples will be taken during the initial visit as well as during the visit to 5 years. They consist of: A genetic collection consisting of a DNA library (3 Ethylene Diamine Triacetic Acid (EDTA) tubes of 6ml - 18 ml). An off-genetics collection consisting of serum and plasma samples, (1 6 ml EDTA tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml).

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

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Other: Clinical and biological assessments - a 5 Years follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion. First visit (Baseline) only: Sociodemographic data, Clinical evaluation, family history At Baseline and 5 years after baseline only: Blood sample BPD diagnosis (using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID II))
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Borderline Personality Disorder<br>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 | Other: Clinical and biological assessments - a 5 Years follow-up<br>* During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | At enrollment | 
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | 1 year after enrollment | 
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | 2 years after enrollment | 
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | 3 years after enrollment | 
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | 4 years after enrollment | 
| Level of shame propensity | Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) | 5 years after enrollment | 
| Number of SA compared to the clinical data obtained in baseline | The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline | At enrollment | 
| Number of SA compared to the clinical data obtained in baseline | 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 | 1 year after enrollment | 
| Number of SA compared to the clinical data obtained in baseline | 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 | 2 years after enrollment | 
| Number of SA compared to the clinical data obtained in baseline | 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 | 3 years after enrollment | 
| Number of SA compared to the clinical data obtained in baseline | 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 | 4 years after enrollment | 
| Number of SA compared to the clinical data obtained in baseline | 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 | 5 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SA compared to the biological data obtained in baseline | The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | At enrollment | 
| Number of SA compared to the biological data obtained in baseline | The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | 1 year after enrollment | 
| Number of SA compared to the biological data obtained in baseline | The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | 2 years after enrollment | 
| Number of SA compared to the biological data obtained in baseline | The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | 3 years after enrollment | 
| Number of SA compared to the biological data obtained in baseline | The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | 4 years after enrollment | 
| Number of SA compared to the biological data obtained in baseline | The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline | 5 years after enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | At enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 1 year after enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 2 years after enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 3 years after enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 4 years after enrollment | 
| Suicidal Ideation | The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 5 years after enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | At enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 1 year after enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 2 years after enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 3 years after enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 4 years after enrollment | 
| Parasuicidal Behaviours | The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS). | 5 years after enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | At enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 1 year after enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 2 years after enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 3 years after enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 4 years after enrollment | 
| Sick leave for a psychiatric condition | The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 5 years after enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | At enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 1 year after enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 2 years after enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 3 years after enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 4 years after enrollment | 
| Hospitalization for a psychiatric condition | The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF). | 5 years after enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | At enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | 1 year after enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | 2 years after enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | 3 years after enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | 4 years after enrollment | 
| The need to emergency psychiatric consult | The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF). | 5 years after enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | At enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | 1 year after enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | 2 years after enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | 3 years after enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | 4 years after enrollment | 
| Major depressive episodes | The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30). | 5 years after enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | At enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | 1 year after enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | 2 years after enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | 3 years after enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | 4 years after enrollment | 
| Global functioning | The Global functioning will be measured using the Functioning Assessment Short Test (FAST). | 5 years after enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | At enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | 1 year after enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | 2 years after enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | 3 years after enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | 4 years after enrollment | 
| Life Quality | The Life Quality will be measured using the Satisfaction With Life Scale (SWLS). | 5 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Follow-Up Study