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Recruiting NCT05913544

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

No phase Interventional Borderline Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SINTYA.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder. Basic parameters: 16 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Variation in explicit impulsivity between groups [Time frame: Baseline]
  • Variation in explicit impulsivity between groups [Time frame: Month 4]
Secondary outcome measures (12)
  • Variation in explicit impulsivity between groups [Time frame: Month 7]
  • Variation in impulsiveness between groups [Time frame: Baseline]
  • Variation in impulsiveness between groups [Time frame: Month 4]
  • Variation in impulsiveness between groups [Time frame: Month 7]
  • BPD severity level between groups [Time frame: Baseline]
  • BPD severity level between groups [Time frame: Month 4]
  • BPD severity level between groups [Time frame: Month 7]
  • Emotional regulation capacities between groups [Time frame: Baseline]
  • Emotional regulation capacities between groups [Time frame: Month 4]
  • Emotional regulation capacities between groups [Time frame: Month 7]
  • Dissociative symptoms between groups [Time frame: Baseline]
  • Dissociative symptoms between groups [Time frame: Month 4]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Nîmes — Nîmes

Identifiers

NCT: NCT05913544 · NIMAO/2022-1/CE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗