CClinicalTrials.gg
RecruitingNCT03994510SHOOUpdated Sep 30, 2025

SHame prOpensity in bOrderline Personality Disorder

An interventional study of Clinical and biological assessments - a 5 Years follow-up in Borderline Personality Disorder, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
688
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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).
02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Psychiatry
  • Suicidal Behavior
  • Borderline Personality Disorder
  • Follow-Up Study
03

In context

Borderline Personality Disorder

269 studies on the registry are indexed under Borderline Personality Disorder; 67 are open to participants now.

This study's planned enrollment of 688 is above the median of 70 across 215 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
688 participants (estimated)

Study arms

  • 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

Interventions

  • OtherClinical 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.

06

What researchers measure

Primary outcomes

  1. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: At enrollment

  2. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: 1 year after enrollment

  3. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: 2 years after enrollment

  4. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: 3 years after enrollment

  5. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: 4 years after enrollment

  6. Level of shame propensity

    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)

    Time frame: 5 years after enrollment

  7. 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

    Time frame: At enrollment

  8. 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

    Time frame: 1 year after enrollment

  9. 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

    Time frame: 2 years after enrollment

  10. 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

    Time frame: 3 years after enrollment

  11. 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

    Time frame: 4 years after enrollment

  12. 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

    Time frame: 5 years after enrollment

Secondary outcomes

  1. 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

    Time frame: At enrollment

  2. 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

    Time frame: 1 year after enrollment

  3. 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

    Time frame: 2 years after enrollment

  4. 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

    Time frame: 3 years after enrollment

  5. 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

    Time frame: 4 years after enrollment

  6. 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

    Time frame: 5 years after enrollment

  7. Suicidal Ideation

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

    Time frame: At enrollment

  8. Suicidal Ideation

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

    Time frame: 1 year after enrollment

  9. Suicidal Ideation

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

    Time frame: 2 years after enrollment

  10. Suicidal Ideation

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

    Time frame: 3 years after enrollment

  11. Suicidal Ideation

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

    Time frame: 4 years after enrollment

  12. Suicidal Ideation

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

    Time frame: 5 years after enrollment

  13. Parasuicidal Behaviours

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

    Time frame: At enrollment

  14. Parasuicidal Behaviours

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

    Time frame: 1 year after enrollment

  15. Parasuicidal Behaviours

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

    Time frame: 2 years after enrollment

  16. Parasuicidal Behaviours

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

    Time frame: 3 years after enrollment

  17. Parasuicidal Behaviours

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

    Time frame: 4 years after enrollment

  18. Parasuicidal Behaviours

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

    Time frame: 5 years after enrollment

  19. 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).

    Time frame: At enrollment

  20. 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).

    Time frame: 1 year after enrollment

  21. 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).

    Time frame: 2 years after enrollment

  22. 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).

    Time frame: 3 years after enrollment

  23. 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).

    Time frame: 4 years after enrollment

  24. 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).

    Time frame: 5 years after enrollment

  25. 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).

    Time frame: At enrollment

  26. 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).

    Time frame: 1 year after enrollment

  27. 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).

    Time frame: 2 years after enrollment

  28. 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).

    Time frame: 3 years after enrollment

  29. 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).

    Time frame: 4 years after enrollment

  30. 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).

    Time frame: 5 years after enrollment

  31. 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).

    Time frame: At enrollment

  32. 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).

    Time frame: 1 year after enrollment

  33. 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).

    Time frame: 2 years after enrollment

  34. 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).

    Time frame: 3 years after enrollment

  35. 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).

    Time frame: 4 years after enrollment

  36. 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).

    Time frame: 5 years after enrollment

  37. 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).

    Time frame: At enrollment

  38. 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).

    Time frame: 1 year after enrollment

  39. 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).

    Time frame: 2 years after enrollment

  40. 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).

    Time frame: 3 years after enrollment

  41. 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).

    Time frame: 4 years after enrollment

  42. 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).

    Time frame: 5 years after enrollment

  43. Global functioning

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

    Time frame: At enrollment

  44. Global functioning

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

    Time frame: 1 year after enrollment

  45. Global functioning

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

    Time frame: 2 years after enrollment

  46. Global functioning

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

    Time frame: 3 years after enrollment

  47. Global functioning

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

    Time frame: 4 years after enrollment

  48. Global functioning

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

    Time frame: 5 years after enrollment

  49. Life Quality

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

    Time frame: At enrollment

  50. Life Quality

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

    Time frame: 1 year after enrollment

  51. Life Quality

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

    Time frame: 2 years after enrollment

  52. Life Quality

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

    Time frame: 3 years after enrollment

  53. Life Quality

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

    Time frame: 4 years after enrollment

  54. Life Quality

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

    Time frame: 5 years after enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03994510
Lead sponsor
University Hospital, Montpellier
Collaborators
INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
Responsible party
Sponsor
First posted
Jun 21, 2019
Start date
Sep 18, 2020
Primary completion
Sep 2031 (estimated)
Completion
Sep 2031 (estimated)
Last update
Sep 30, 2025

Study contacts

Déborah DUCASSE, MD, PhD
Contact
d-ducasse@chu-montpellier.fr
(0)467338581 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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