SHame prOpensity in bOrderline Personality Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical and biological assessments - a 5 Years follow-up.
- Who it may be relevant to
- Registry conditions: Borderline Personality Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
Overview
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
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).
Interventions
- Other 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.
Primary outcome measures
- Level of shame propensity [Time frame: At enrollment]
- Level of shame propensity [Time frame: 1 year after enrollment]
- Level of shame propensity [Time frame: 2 years after enrollment]
- Level of shame propensity [Time frame: 3 years after enrollment]
- Level of shame propensity [Time frame: 4 years after enrollment]
- Level of shame propensity [Time frame: 5 years after enrollment]
- Number of SA compared to the clinical data obtained in baseline [Time frame: At enrollment]
- Number of SA compared to the clinical data obtained in baseline [Time frame: 1 year after enrollment]
- Number of SA compared to the clinical data obtained in baseline [Time frame: 2 years after enrollment]
- Number of SA compared to the clinical data obtained in baseline [Time frame: 3 years after enrollment]
Secondary outcome measures (12)
- Number of SA compared to the biological data obtained in baseline [Time frame: At enrollment]
- Number of SA compared to the biological data obtained in baseline [Time frame: 1 year after enrollment]
- Number of SA compared to the biological data obtained in baseline [Time frame: 2 years after enrollment]
- Number of SA compared to the biological data obtained in baseline [Time frame: 3 years after enrollment]
- Number of SA compared to the biological data obtained in baseline [Time frame: 4 years after enrollment]
- Number of SA compared to the biological data obtained in baseline [Time frame: 5 years after enrollment]
- Suicidal Ideation [Time frame: At enrollment]
- Suicidal Ideation [Time frame: 1 year after enrollment]
- Suicidal Ideation [Time frame: 2 years after enrollment]
- Suicidal Ideation [Time frame: 3 years after enrollment]
- Suicidal Ideation [Time frame: 4 years after enrollment]
- Suicidal Ideation [Time frame: 5 years after enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- University Hospital of Montpellier — Montpellier
Identifiers
NCT: NCT03994510 · RECHMPL18_0286