NCT05913544招募中不适用
Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder: a Study Model of Impulsivity Management
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年11月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Variation in explicit impulsivity between groups
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Refusal to participate.
- •Existence of a neurological pathology or cerebral sequelae of organic origin which could affect neurocognitive performance.
- •Intelligence quotient <
- •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.
研究组 & 干预措施
SINTYA group
Experimental
干预措施: SINTYA (Other)
Control
No Intervention
结局指标
主要结局
Variation in explicit impulsivity between groups
时间窗: Month 4
UPPS-S (Impulsive Behavior Scale Short version score)
Variation in explicit impulsivity between groups
时间窗: Baseline
UPPS-S (Impulsive Behavior Scale Short version score)
次要结局
- Dissociative symptoms between groups(Month 7)
- Variation in explicit impulsivity between groups(Month 7)
- Number of self-destructive behaviors between groups(Month 7)
- Variation in impulsiveness between groups(Month 7)
- Risk taking between groups(Month 7)
- BPD severity level between groups(Month 7)
- Emotional regulation capacities between groups(Month 7)
- Aggression between groups(Month 7)
- Psychosocial functioning between groups(Month 7)
- Decision making under risk conditions between groups(Month 7)
- Level of suicide risk between groups(Month 7)
- Ruminations between groups(Month 7)
- Number of impulsive behaviors between groups(Month 7)
- Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups(Month 7)
- Implicit impulsivity between groups(Month 7)
- Neurocognitive evaluation of implicit impulsivity between groups(Month 7)
- Variation in impulsiveness between groups(Baseline)
- Variation in impulsiveness between groups(Month 4)
- BPD severity level between groups(Baseline)
- BPD severity level between groups(Month 4)
- Emotional regulation capacities between groups(Baseline)
- Emotional regulation capacities between groups(Month 4)
- Dissociative symptoms between groups(Baseline)
- Dissociative symptoms between groups(Month 4)
- Aggression between groups(Baseline)
- Aggression between groups(Month 4)
- Ruminations between groups(Baseline)
- Ruminations between groups(Month 4)
- Number of self-destructive behaviors between groups(Baseline)
- Number of self-destructive behaviors between groups(Month 4)
- Number of impulsive behaviors between groups(Baseline)
- Number of impulsive behaviors between groups(Month 4)
- Level of suicide risk between groups(Baseline)
- Level of suicide risk between groups(Month 4)
- Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups(12 Months prior to inclusion)
- Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups(Baseline)
- Number of psychiatric hospitalizations and emergency visits for psychiatric reasons between groups(Month 4)
- Psychosocial functioning between groups(Baseline)
- Psychosocial functioning between groups(Month 4)
- Implicit impulsivity between groups(Baseline)
- Implicit impulsivity between groups(Month 4)
- Neurocognitive evaluation of implicit impulsivity between groups(Baseline)
- Neurocognitive evaluation of implicit impulsivity between groups(Month 4)
- Risk taking between groups(Baseline)
- Risk taking between groups(Month 4)
- Decision making under risk conditions between groups(Baseline)
- Decision making under risk conditions between groups(Month 4)
研究者
研究点 (1)
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