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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Variation in explicit impulsivity between groups [Срок оценки: Baseline]
• Variation in explicit impulsivity between groups [Срок оценки: Month 4]

Вторичные конечные точки (12)

• Variation in explicit impulsivity between groups [Срок оценки: Month 7]
• Variation in impulsiveness between groups [Срок оценки: Baseline]
• Variation in impulsiveness between groups [Срок оценки: Month 4]
• Variation in impulsiveness between groups [Срок оценки: Month 7]
• BPD severity level between groups [Срок оценки: Baseline]
• BPD severity level between groups [Срок оценки: Month 4]
• BPD severity level between groups [Срок оценки: Month 7]
• Emotional regulation capacities between groups [Срок оценки: Baseline]
• Emotional regulation capacities between groups [Срок оценки: Month 4]
• Emotional regulation capacities between groups [Срок оценки: Month 7]
• Dissociative symptoms between groups [Срок оценки: Baseline]
• Dissociative symptoms between groups [Срок оценки: Month 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Nîmes — Nîmes

Идентификаторы

NCT: NCT05913544 · NIMAO/2022-1/CE-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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