SHame prOpensity in bOrderline Personality Disorder

Borderline Personality Disorder Clinical Trial

— SHOO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03994510
• Other study ID #: UF 7681
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: September 2029

Study information

• Verified date: June 2022
• Source: University Hospital, Montpellier
• Contact: Déborah DUCASSE, MD, PhD
• Phone: (0)467338581
• Email: d-ducasse[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 688
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of shame propensity	Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)	At enrollment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	At enrollment
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	1 year after enrollment
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	2 years after enrollment
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	3 years after enrollment
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	4 years after enrollment
Secondary	Suicidal Ideation	The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	5 years after enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	At enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	1 year after enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	2 years after enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	3 years after enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	4 years after enrollment
Secondary	Parasuicidal Behaviours	The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).	5 years after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	At enrollment
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	1 year after enrollment
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	2 years after enrollment
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	3 years after enrollment
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	4 years after enrollment
Secondary	Global functioning	The Global functioning will be measured using the Functioning Assessment Short Test (FAST).	5 years after enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	At enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	1 year after enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	2 years after enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	3 years after enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	4 years after enrollment
Secondary	Life Quality	The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).	5 years after enrollment