SHame prOpensity in bOrderline Personality Disorder
ConditionBorderline Personality Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Clinical and biological assessments - a 5 Years follow-up
Other interventionDuring 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.
Treatment groups
688 Participants
are divided into 1 treatment groupGroup A: Patients with Borderline Personality DisorderOther 1 intervention
Trial outcomes
Primary outcomes
1
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Time frame
At enrollment2
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Time frame
1 year after enrollment3
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Time frame
2 years after enrollment4
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Time frame
3 years after enrollmentSecondary outcomes
1
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
Time frame
At enrollment2
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
Time frame
1 year after enrollment3
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
Time frame
2 years after enrollment4
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
Time frame
3 years after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
Collaborator
Source ClinicalTrials.gov