SHame prOpensity in bOrderline Personality Disorder (SHOO)

Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Other: Clinical and biological assessments - a 5 Years follow-up

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).

• Study Type: Interventional
• Enrollment (Estimated): 688
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Déborah DUCASSE, MD, PhD; Phone Number: +33 (0)467338581; Email: d-ducasse@chu-montpellier.fr

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Recruiting
      • University Hospital of Montpellier
      • Contact: Laëtitia LACOURT; Phone Number: (0)467335663; Email: l-lacourt@chu-montpellier.fr
      • Contact: Catherine GENTY; Phone Number: +33 (0)499614575; Email: c-genty@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with Borderline Personality Disorder; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At enrollment
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	1 year after enrollment
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	2 years after enrollment
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	3 years after enrollment
Number of SA compared to the biological 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 biological data obtained in baseline	4 years after enrollment
Number of SA compared to the biological 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 biological data obtained in baseline	5 years after enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	At enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	1 year after enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	2 years after enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	3 years after enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	4 years after enrollment
Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	5 years after enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	At enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	1 year after enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	2 years after enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	3 years after enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	4 years after enrollment
Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	5 years after enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	At enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	1 year after enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	2 years after enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	3 years after enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	4 years after enrollment
Sick leave for a psychiatric condition	The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).	5 years after enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	At enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	1 year after enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	2 years after enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	3 years after enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	4 years after enrollment
Hospitalization for a psychiatric condition	The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).	5 years after enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	At enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	1 year after enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	2 years after enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	3 years after enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	4 years after enrollment
The need to emergency psychiatric consult	The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).	5 years after enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	At enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	1 year after enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	2 years after enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	3 years after enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	4 years after enrollment
Major depressive episodes	The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).	5 years after enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	At enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	1 year after enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	2 years after enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	3 years after enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	4 years after enrollment
Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	5 years after enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	At enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	1 year after enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	2 years after enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	3 years after enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	4 years after enrollment
Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	5 years after enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Psychiatry; Suicidal Behavior; Borderline Personality Disorder; Follow-Up Study
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: RECHMPL18_0286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No