SHame PrOpensity in BOrderline Personality Disorder
- Conditions
- Borderline Personality Disorder
- Interventions
- Other: Clinical and biological assessments - a 5 Years follow-up
- Registration Number
- NCT03994510
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 688
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Borderline Personality Disorder Clinical and biological assessments - a 5 Years follow-up 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
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Parasuicidal Behaviours 5 years after enrollment The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Sick leave for a psychiatric condition 5 years after enrollment The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Major depressive episodes 5 years after enrollment The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Hospitalization for a psychiatric condition 5 years after enrollment The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
The need to emergency psychiatric consult 5 years after enrollment The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Global functioning 5 years after enrollment The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Suicidal Ideation 5 years after enrollment The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Life Quality 5 years after enrollment The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Number of SA compared to the biological 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 biological data obtained in baseline
Trial Locations
- Locations (1)
University Hospital of Montpellier
🇫🇷Montpellier, Hérault, France