SHame prOpensity in bOrderline Personality Disorder (SHOO)

September 24, 2025 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
688

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of shame propensity
Time Frame: At enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
At enrollment
Level of shame propensity
Time Frame: 1 year after enrollment
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
Time Frame: 2 years after enrollment
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
Time Frame: 3 years after enrollment
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
Time Frame: 4 years after enrollment
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
Time Frame: 5 years after enrollment
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
Time Frame: At enrollment
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
Time Frame: 1 year 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
1 year after enrollment
Number of SA compared to the clinical data obtained in baseline
Time Frame: 2 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
2 years after enrollment
Number of SA compared to the clinical data obtained in baseline
Time Frame: 3 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
3 years after enrollment
Number of SA compared to the clinical data obtained in baseline
Time Frame: 4 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
4 years after enrollment
Number of SA compared to the clinical data obtained in baseline
Time Frame: 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
5 years after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of SA compared to the biological data obtained in baseline
Time Frame: At enrollment
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
Time Frame: 1 year after enrollment
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
Time Frame: 2 years after enrollment
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
Time Frame: 3 years after enrollment
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
Time Frame: 4 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
4 years after enrollment
Number of SA compared to the biological data obtained in baseline
Time Frame: 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
5 years after enrollment
Suicidal Ideation
Time Frame: At enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
At enrollment
Suicidal Ideation
Time Frame: 1 year after enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
1 year after enrollment
Suicidal Ideation
Time Frame: 2 years after enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
2 years after enrollment
Suicidal Ideation
Time Frame: 3 years after enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
3 years after enrollment
Suicidal Ideation
Time Frame: 4 years after enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
4 years after enrollment
Suicidal Ideation
Time Frame: 5 years after enrollment
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
5 years after enrollment
Parasuicidal Behaviours
Time Frame: At enrollment
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
At enrollment
Parasuicidal Behaviours
Time Frame: 1 year after enrollment
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
1 year after enrollment
Parasuicidal Behaviours
Time Frame: 2 years after enrollment
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
2 years after enrollment
Parasuicidal Behaviours
Time Frame: 3 years after enrollment
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
3 years after enrollment
Parasuicidal Behaviours
Time Frame: 4 years after enrollment
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
4 years after enrollment
Parasuicidal Behaviours
Time Frame: 5 years after enrollment
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
Time Frame: At enrollment
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
Time Frame: 1 year after enrollment
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
Time Frame: 2 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).
2 years after enrollment
Sick leave for a psychiatric condition
Time Frame: 3 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).
3 years after enrollment
Sick leave for a psychiatric condition
Time Frame: 4 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).
4 years after enrollment
Sick leave for a psychiatric condition
Time Frame: 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).
5 years after enrollment
Hospitalization for a psychiatric condition
Time Frame: At enrollment
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
Time Frame: 1 year after enrollment
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
Time Frame: 2 years after enrollment
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
Time Frame: 3 years after enrollment
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
Time Frame: 4 years after enrollment
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
Time Frame: 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).
5 years after enrollment
The need to emergency psychiatric consult
Time Frame: At enrollment
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
Time Frame: 1 year after enrollment
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
Time Frame: 2 years after enrollment
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
Time Frame: 3 years after enrollment
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
Time Frame: 4 years after enrollment
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
Time Frame: 5 years after enrollment
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
Time Frame: At 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).
At enrollment
Major depressive episodes
Time Frame: 1 year 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).
1 year after enrollment
Major depressive episodes
Time Frame: 2 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).
2 years after enrollment
Major depressive episodes
Time Frame: 3 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).
3 years after enrollment
Major depressive episodes
Time Frame: 4 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).
4 years after enrollment
Major depressive episodes
Time Frame: 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).
5 years after enrollment
Global functioning
Time Frame: At enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
At enrollment
Global functioning
Time Frame: 1 year after enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
1 year after enrollment
Global functioning
Time Frame: 2 years after enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
2 years after enrollment
Global functioning
Time Frame: 3 years after enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
3 years after enrollment
Global functioning
Time Frame: 4 years after enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
4 years after enrollment
Global functioning
Time Frame: 5 years after enrollment
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
5 years after enrollment
Life Quality
Time Frame: At enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
At enrollment
Life Quality
Time Frame: 1 year after enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
1 year after enrollment
Life Quality
Time Frame: 2 years after enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
2 years after enrollment
Life Quality
Time Frame: 3 years after enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
3 years after enrollment
Life Quality
Time Frame: 4 years after enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
4 years after enrollment
Life Quality
Time Frame: 5 years after enrollment
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
5 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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