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NCT Number: NCT03994510

SHame prOpensity in 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

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Suicidal Ideation

    Time frame: At enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  8. Suicidal Ideation

    Time frame: 1 year after enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  9. Suicidal Ideation

    Time frame: 2 years after enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  10. Suicidal Ideation

    Time frame: 3 years after enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  11. Suicidal Ideation

    Time frame: 4 years after enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  12. Suicidal Ideation

    Time frame: 5 years after enrollment

    The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  13. Parasuicidal Behaviours

    Time frame: At enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  14. Parasuicidal Behaviours

    Time frame: 1 year after enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  15. Parasuicidal Behaviours

    Time frame: 2 years after enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  16. Parasuicidal Behaviours

    Time frame: 3 years after enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  17. Parasuicidal Behaviours

    Time frame: 4 years after enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  18. Parasuicidal Behaviours

    Time frame: 5 years after enrollment

    The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. 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).

  26. 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).

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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).

  38. 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).

  39. 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).

  40. 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).

  41. 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).

  42. 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).

  43. Global functioning

    Time frame: At enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  44. Global functioning

    Time frame: 1 year after enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  45. Global functioning

    Time frame: 2 years after enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  46. Global functioning

    Time frame: 3 years after enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  47. Global functioning

    Time frame: 4 years after enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  48. Global functioning

    Time frame: 5 years after enrollment

    The Global functioning will be measured using the Functioning Assessment Short Test (FAST).

  49. Life Quality

    Time frame: At enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

  50. Life Quality

    Time frame: 1 year after enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

  51. Life Quality

    Time frame: 2 years after enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

  52. Life Quality

    Time frame: 3 years after enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

  53. Life Quality

    Time frame: 4 years after enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

  54. Life Quality

    Time frame: 5 years after enrollment

    The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).

Study contacts

Contact information is provided by the study sponsor or research team.

Déborah DUCASSE, MD, PhD

CONTACT

[email protected]

(0)467338581 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

Registry information

Official study title

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

Acronym: SHOO

Important dates

Study start
2020
Primary completion
2031
Study completion
2031
First posted
Jun 21, 2019
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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