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Trial record 3 of 611 for:    Personality Disorders

SHame prOpensity in bOrderline Personality Disorder (SHOO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03994510
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Other: Clinical and biological assessments - a 5 Years follow-up Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 688 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

First visit (Baseline) only: Sociodemographic data, Clinical evaluation, family history

At Baseline and 5 years after baseline only:

  • Blood sample
  • BPD diagnosis (using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID II))
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994510


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

Locations
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France
University Hospital of Montpellier Not yet recruiting
Montpellier, Hérault, France, 34295
Contact: Laëtitia LACOURT    (0)467335663    l-lacourt@chu-montpellier.fr   
Contact: Catherine GENTY    (0)499614575 ext +33    c-genty@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03994510     History of Changes
Other Study ID Numbers: UF 7681
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Psychiatry
Suicidal Behavior
Borderline Personality Disorder
Follow-Up Study

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders