SHame prOpensity in bOrderline Personality Disorder

NCT03994510 | Recruiting

• 1 other identifier: RECHMPL18_0286
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 1

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

Conditions

Borderline Personality Disorder

Keywords

Psychiatry; Suicidal Behavior; Borderline Personality Disorder; Follow-Up Study

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (54)

• Number of SA compared to the biological data obtained in baseline

  At enrollment

• Number of SA compared to the biological data obtained in baseline

  1 year after enrollment

• Number of SA compared to the biological data obtained in baseline

  2 years after enrollment

• Number of SA compared to the biological data obtained in baseline

  3 years after enrollment

• Number of SA compared to the biological data obtained in baseline

  4 years after enrollment

Study Arms (1)

Patients with Borderline Personality Disorder

OTHER

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

Interventions

Clinical and biological assessments - a 5 Years follow-up OTHER

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.

Patients with Borderline Personality Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Deprived of liberty (by judicial or administrative decision)
• Protected by law (guardianship)
• Not affiliated to a social security scheme

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier: collaborator

Study Sites (1)

University Hospital of Montpellier

Montpellier, Hérault, 34295, France

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Déborah DUCASSE, MD, PhD

CONTACT

(0)467338581; d-ducasse@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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))

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: September 18, 2020
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)