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NCT Number: NCT05913544

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

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).

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Aurélie Schandrin

SUB_INVESTIGATOR

Clémentine Estric

PRINCIPAL_INVESTIGATOR

Emmanuel Diaz

SUB_INVESTIGATOR

Ismael Conejero

SUB_INVESTIGATOR

Jorge Lopez Castroman

SUB_INVESTIGATOR

Mocrane Abbar

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SINTYA

Other

10-week psychotherapy program consisting of a weekly 1h30 hour group therapy session plus 1 hour individual therapy session

Primary outcomes

  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 outcomes

  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)

Study contacts

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

Clémentine Estric

CONTACT

[email protected]

04 66 68 34 26

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management

Acronym: SINTYA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Nov 24, 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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