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RecruitingNCT05913544SINTYAUpdated Nov 24, 2025

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

An interventional study of SINTYA in Borderline Personality Disorder, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 1 site in France. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Borderline Personality Disorder
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 74 is close to the median of 70 across 215 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

04

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    SINTYA group

    Other: SINTYA

  • No intervention
    Control

Interventions

  • OtherSINTYA

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

06

What researchers measure

Primary outcomes

  1. Variation in explicit impulsivity between groups

    UPPS-S (Impulsive Behavior Scale Short version score)

    Time frame: Baseline

  2. Variation in explicit impulsivity between groups

    UPPS-S (Impulsive Behavior Scale Short version score)

    Time frame: Month 4

Secondary outcomes

  1. Variation in explicit impulsivity between groups

    UPPS-S (Impulsive Behavior Scale Short version score)

    Time frame: Month 7

  2. Variation in impulsiveness between groups

    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

    Time frame: Baseline

  3. Variation in impulsiveness between groups

    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

    Time frame: Month 4

  4. Variation in impulsiveness between groups

    Barratt Impulsiveness Scale (BIS-11) (score out of 120)

    Time frame: Month 7

  5. BPD severity level between groups

    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

    Time frame: Baseline

  6. BPD severity level between groups

    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

    Time frame: Month 4

  7. BPD severity level between groups

    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (score out of 36)

    Time frame: Month 7

  8. Emotional regulation capacities between groups

    Difficulties in Emotion Regulation Scale (DERS-18)

    Time frame: Baseline

  9. Emotional regulation capacities between groups

    Difficulties in Emotion Regulation Scale (DERS-18)

    Time frame: Month 4

  10. Emotional regulation capacities between groups

    Difficulties in Emotion Regulation Scale (DERS-18)

    Time frame: Month 7

  11. Dissociative symptoms between groups

    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

    Time frame: Baseline

  12. Dissociative symptoms between groups

    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

    Time frame: Month 4

  13. Dissociative symptoms between groups

    Dissociative Experiences Scale (DES): a score of 25 or higher is predictive of dissociative disorder

    Time frame: Month 7

  14. Aggression between groups

    Aggression Questionnaire (AQ-12)

    Time frame: Baseline

  15. Aggression between groups

    Aggression Questionnaire (AQ-12)

    Time frame: Month 4

  16. Aggression between groups

    Aggression Questionnaire (AQ-12)

    Time frame: Month 7

  17. Ruminations between groups

    Rumination Reflection Questionnaire (RRQ)

    Time frame: Baseline

  18. Ruminations between groups

    Rumination Reflection Questionnaire (RRQ)

    Time frame: Month 4

  19. Ruminations between groups

    Rumination Reflection Questionnaire (RRQ)

    Time frame: Month 7

  20. Number of self-destructive behaviors between groups

    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

    Time frame: Baseline

  21. Number of self-destructive behaviors between groups

    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

    Time frame: Month 4

  22. Number of self-destructive behaviors between groups

    Number of self-destructive/self-mutilatory/parasuicidal acts reported by the patient in a clinical interview

    Time frame: Month 7

  23. Number of impulsive behaviors between groups

    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

    Time frame: Baseline

  24. Number of impulsive behaviors between groups

    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

    Time frame: Month 4

  25. Number of impulsive behaviors between groups

    Number of impulsive behaviors (food, motor vehicles, sexual, drug-related)

    Time frame: Month 7

  26. Level of suicide risk between groups

    Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline

  27. Level of suicide risk between groups

    Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Month 4

  28. Level of suicide risk between groups

    Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Month 7

  29. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups

    Information taken from patient medical file

    Time frame: 12 Months prior to inclusion

  30. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups

    Information taken from patient medical file

    Time frame: Baseline

  31. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups

    Information taken from patient medical file

    Time frame: Month 4

  32. Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups

    Information taken from patient medical file

    Time frame: Month 7

  33. Psychosocial functioning between groups

    Functional Assessment Staging Tool (FAST)

    Time frame: Baseline

  34. Psychosocial functioning between groups

    Functional Assessment Staging Tool (FAST)

    Time frame: Month 4

  35. Psychosocial functioning between groups

    Functional Assessment Staging Tool (FAST)

    Time frame: Month 7

  36. Implicit impulsivity between groups

    Continuous Performance Test (CPT)

    Time frame: Baseline

  37. Implicit impulsivity between groups

    Continuous Performance Test (CPT)

    Time frame: Month 4

  38. Implicit impulsivity between groups

    Continuous Performance Test (CPT)

    Time frame: Month 7

  39. Neurocognitive evaluation of implicit impulsivity between groups

    Emotional Stroop (SE) customized to the study

    Time frame: Baseline

  40. Neurocognitive evaluation of implicit impulsivity between groups

    Emotional Stroop (SE) customized to the study

    Time frame: Month 4

  41. Neurocognitive evaluation of implicit impulsivity between groups

    Emotional Stroop (SE) customized to the study

    Time frame: Month 7

  42. Risk taking between groups

    Balloon Analogue Risk Task (BART)

    Time frame: Baseline

  43. Risk taking between groups

    Balloon Analogue Risk Task (BART)

    Time frame: Month 4

  44. Risk taking between groups

    Balloon Analogue Risk Task (BART)

    Time frame: Month 7

  45. Decision making under risk conditions between groups

    Game Dice Task (GDT)

    Time frame: Baseline

  46. Decision making under risk conditions between groups

    Game Dice Task (GDT)

    Time frame: Month 4

  47. Decision making under risk conditions between groups

    Game Dice Task (GDT)

    Time frame: Month 7

07

Study locations

1 of 1 sites recruiting
  • CHU de Nîmes
    Nîmes, France
    • Anissa Megzari · Contact · drc@chu-nimes.fr · 04.66.68.42.36
    • Clémentine Estric · Principal investigator
    • Mocrane Abbar · Sub investigator
    • Jorge Lopez Castroman · Sub investigator
    • Ismael Conejero · Sub investigator
    • Aurélie Schandrin · Sub investigator
    • Emmanuel Diaz · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Analytic code

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 Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05913544
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Nov 8, 2023
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Nov 24, 2025

Study contacts

Clémentine Estric
Contact
clementine.estric@chu-nimes.fr
04 66 68 34 26
Clémentine Estric
principal investigator · CHU de Nimes

Oversight

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

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