SHame prOpensity in bOrderline Personality Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
Clinical and biological assessments - a 5 Years follow-up: 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.
Study summary
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
Eligibility
Primary outcome measure(s)
- Level of shame propensity — At enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA) - Level of shame propensity — 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 — 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 — 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 — 4 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 — 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 — 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 — 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 — 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 — 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 — 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 - Number of SA compared to the clinical data obtained in baseline — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital of Montpellier | Montpellier | Hérault | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03994510 on ClinicalTrials.gov ↗ ← All trials in France