Mentalization-Based Treatment in Groups for Adolescents With Borderline Personality Disorder (BPD) or Subthreshold BPD Versus Treatment As Usual - the M-GAB Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- The Borderline Personality Feature Scale for Children (BPFS-C)
研究概览
简要总结
Background: Although it is now possible to diagnose Borderline Personality Disorder (BPD) in adolescents younger than 18 years according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), and studies indicates that BPD can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent BPD exists. Mentalization-based treatment (MBT), including group psychotherapy, has repeatedly shown to be effective in treating adult BPD, but in the case of adolescents, only individual MBT have been tested and found to be effective.
Aims/hypotheses: We will test whether group based MBT (MBT-G), including an introductory programme for patients (MBT-I) and their parents (MBT-P) is more effective than Treatment As Usual (TAU) in treating adolescents with BPD or subthreshold BPD.
Methods/Design: 112 patients referred to child and adolescent psychiatric clinics in Region Zealand will be randomized to either MBT or TAU. Inclusion criteria: Meeting DSM-V BPD-criteria at the threshold (five criteria) or sub threshold level (4 criteria). Follow-up will be at three and 12 months.
Discussion: Early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. In addition to being cost effective, using the group modality in the treatment of BPD may have several advantages. This is the first Randomized Controlled Trial (RCT) to test the effectiveness of MBT in groups for adolescents.
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
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet a minimum of 4 DSM-5 BPD criteria
- •Have parent's or parent substitute's commitment and ability to participate in the MBT-Parents program.
- •Score 67< BPFS-C
排除标准
- •Comorbid diagnosis of pervasive developmental disorder, learning disability (75 < IQ), anorexia, current psychosis, diagnosis of schizophrenia or schizotypal personality disorder, antisocial personality disorder as well as any other axis-I or axis-II psychopathology considered to be the primary diagnosis.
- •Current psychiatric inpatient treatment
- •Current (past two months) substance dependence (but not substance misuse)
- •Participation in concurrent psychotherapeutic treatment outside the MBT program
- •Not able to speak Danish
- •Lack of informed consent
结局指标
主要结局
The Borderline Personality Feature Scale for Children (BPFS-C)
时间窗: Change from baseline at 30 weeks
次要结局
- The Childrens' Global Assessment Scale (CGAS)(Change from baseline at 40 weeks)
- The childhood behaviour checklist (CBCL, Parental outcome measure)(Change from baseline at 30 weeks)
- The borderline personality feature scale for Children - parental version (BPFS-P)(Change from baseline at 30 weeks)
- Number of patients' hospital admissions and visits to the emergency room(Change from baseline at 40 weeks)
- The Youth Self-Report (YSR)(Change from baseline at 40 weeks)
- Becks Depression Inventory for Youth(Change from Baseline in at 40 weeks)
- The Risk-Taking and Self-Harm Inventory for adolescents (RTSHIA)(Chage from baseline at 30 weeks)
- ZAN-BPD Zanarini Rating Scale for Borderline Personality Disorder(Change from baseline at 40 weeks)
- The Health of the Nation Outcome Scale for Children and Adolescent (HoNOSCA)(Change from baseline at 40 weeks)