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Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder (SINTYA)

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ClinicalTrials.gov Identifier: NCT05913544
Recruitment Status : Recruiting
First Posted : June 22, 2023
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
Borderline personality disorder (BPD) is a severe, high-suicidal psychiatric disorder associated with impulsive, endangering behaviors. Young patients between 16 and 25 years old do not respond to traditional psychotherapies, which are often long and not adapted to their neurocognitive alterations linked to early trauma. The study authors hypothesize the SINTYA therapy program (one group session and one individual session weekly for 10 weeks) would reduce the level of impulsivity and clinical symptomatology (severity of the BPD; emotional regulation difficulties; dissociative symptoms; aggressiveness; ruminations; the number of self-destructive behaviors and suicidal acts; impulsive behaviors; level of suicide risk and hopelessness; the number of psychiatric hospitalizations and emergency visits for psychiatric reasons; and finally improving psychosocial functioning).

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Other: SINTYA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management
Actual Study Start Date : November 8, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SINTYA group Other: SINTYA
10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Variation in explicit impulsivity between groups [ Time Frame: Baseline ]
    UPPS-S (Impulsive Behavior Scale Short version score)

  2. Variation in explicit impulsivity between groups [ Time Frame: Month 4 ]
    UPPS-S (Impulsive Behavior Scale Short version score)


Secondary Outcome Measures :
  1. Variation in explicit impulsivity between groups [ Time Frame: Month 7 ]
    UPPS-S (Impulsive Behavior Scale Short version score)

  2. Variation in impulsiveness between groups [ Time Frame: Baseline ]
    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

  3. Variation in impulsiveness between groups [ Time Frame: Month 4 ]
    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

  4. Variation in impulsiveness between groups [ Time Frame: Month 7 ]
    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

  5. BPD severity level between groups [ Time Frame: Baseline ]
    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

  6. BPD severity level between groups [ Time Frame: Month 4 ]
    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

  7. BPD severity level between groups [ Time Frame: Month 7 ]
    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

  8. Emotional regulation capacities between groups [ Time Frame: Baseline ]
    Difficulties in Emotion Regulation Scale (DERS-18)

  9. Emotional regulation capacities between groups [ Time Frame: Month 4 ]
    Difficulties in Emotion Regulation Scale (DERS-18)

  10. Emotional regulation capacities between groups [ Time Frame: Month 7 ]
    Difficulties in Emotion Regulation Scale (DERS-18)

  11. Dissociative symptoms between groups [ Time Frame: Baseline ]
    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

  12. Dissociative symptoms between groups [ Time Frame: Month 4 ]
    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

  13. Dissociative symptoms between groups [ Time Frame: Month 7 ]
    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

  14. Aggression between groups [ Time Frame: Baseline ]
    Aggression Questionnaire (AQ-12)

  15. Aggression between groups [ Time Frame: Month 4 ]
    Aggression Questionnaire (AQ-12)

  16. Aggression between groups [ Time Frame: Month 7 ]
    Aggression Questionnaire (AQ-12)

  17. Ruminations between groups [ Time Frame: Baseline ]
    Rumination Reflection Questionnaire (RRQ)

  18. Ruminations between groups [ Time Frame: Month 4 ]
    Rumination Reflection Questionnaire (RRQ)

  19. Ruminations between groups [ Time Frame: Month 7 ]
    Rumination Reflection Questionnaire (RRQ)

  20. Number of self-destructive behaviors between groups [ Time Frame: Baseline ]
    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

  21. Number of self-destructive behaviors between groups [ Time Frame: Month 4 ]
    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

  22. Number of self-destructive behaviors between groups [ Time Frame: Month 7 ]
    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

  23. Number of impulsive behaviors between groups [ Time Frame: Baseline ]
    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

  24. Number of impulsive behaviors between groups [ Time Frame: Month 4 ]
    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

  25. Number of impulsive behaviors between groups [ Time Frame: Month 7 ]
    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

  26. Level of suicide risk between groups [ Time Frame: Baseline ]
    Columbia-Suicide Severity Rating Scale (C-SSRS)

  27. Level of suicide risk between groups [ Time Frame: Month 4 ]
    Columbia-Suicide Severity Rating Scale (C-SSRS)

  28. Level of suicide risk between groups [ Time Frame: Month 7 ]
    Columbia-Suicide Severity Rating Scale (C-SSRS)

  29. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups [ Time Frame: 12 Months prior to inclusion ]
    Information taken from patient medical file

  30. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups [ Time Frame: Baseline ]
    Information taken from patient medical file

  31. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups [ Time Frame: Month 4 ]
    Information taken from patient medical file

  32. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups [ Time Frame: Month 7 ]
    Information taken from patient medical file

  33. Psychosocial functioning between groups [ Time Frame: Baseline ]
    Functional Assessment Staging Tool (FAST)

  34. Psychosocial functioning between groups [ Time Frame: Month 4 ]
    Functional Assessment Staging Tool (FAST)

  35. Psychosocial functioning between groups [ Time Frame: Month 7 ]
    Functional Assessment Staging Tool (FAST)

  36. Implicit impulsivity between groups [ Time Frame: Baseline ]
    Continuous Performance Test (CPT)

  37. Implicit impulsivity between groups [ Time Frame: Month 4 ]
    Continuous Performance Test (CPT)

  38. Implicit impulsivity between groups [ Time Frame: Month 7 ]
    Continuous Performance Test (CPT)

  39. Neurocognitive evaluation of implicit impulsivity between groups [ Time Frame: Baseline ]
    Emotional Stroop (SE) customized to the study

  40. Neurocognitive evaluation of implicit impulsivity between groups [ Time Frame: Month 4 ]
    Emotional Stroop (SE) customized to the study

  41. Neurocognitive evaluation of implicit impulsivity between groups [ Time Frame: Month 7 ]
    Emotional Stroop (SE) customized to the study

  42. Risk taking between groups [ Time Frame: Baseline ]
    Balloon Analogue Risk Task (BART)

  43. Risk taking between groups [ Time Frame: Month 4 ]
    Balloon Analogue Risk Task (BART)

  44. Risk taking between groups [ Time Frame: Month 7 ]
    Balloon Analogue Risk Task (BART)

  45. Decision making under risk conditions between groups [ Time Frame: Baseline ]
    Game Dice Task (GDT)

  46. Decision making under risk conditions between groups [ Time Frame: Month 4 ]
    Game Dice Task (GDT)

  47. Decision making under risk conditions between groups [ Time Frame: Month 7 ]
    Game Dice Task (GDT)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of BPD according to DSM-5 criteria and BPQ-80 scale.
  • High BPD severity level: ZAN-BPD (score ≥ 18/36).
  • Understand, write and read French.
  • Be able to understand the nature, purpose and methodology of the study and agree to cooperate during evaluations.
  • Have signed the informed consent.
  • For minor patients, have signed the parental consent by at least one holder of parental authority.

Exclusion Criteria:

  • Refusal to participate.
  • Existence of a neurological pathology or cerebral sequelae of organic origin which could affect neurocognitive performance.
  • Intelligence quotient < 70.
  • Lifetime diagnosis of schizoaffective disorder or schizophrenia (MINI-7).
  • Previous or current participation in specific psychotherapy for BPD.
  • Subject deprived of liberty (by judicial or administrative decision) and/or protected by law.
  • Inclusion in another study including psychotherapy for the duration of the study.
  • Inclusion in a drug RIPH1 study or in a REC study (European regulation of clinical trials) for the entire duration of the study.
  • Subject in period of exclusion from another research protocol.
Contacts and Locations
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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): NCT05913544


Contacts
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Contact: Clémentine Estric 04 66 68 34 26 clementine.estric@chu-nimes.fr

Locations
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France
CHU de Nîmes Recruiting
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Clémentine Estric         
Sub-Investigator: Mocrane Abbar         
Sub-Investigator: Jorge Lopez Castroman         
Sub-Investigator: Ismael Conejero         
Sub-Investigator: Aurélie Schandrin         
Sub-Investigator: Emmanuel Diaz         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Clémentine Estric CHU de Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT05913544    
Other Study ID Numbers: NIMAO/2022-1/CE-01
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders