Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview
研究概览
简要总结
The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.
详细描述
Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. Mentalization-based therapy is an example of an evidence-based treatment that currently has empirical support as an 18-months outpatient program for borderline personality disorder. However, this duration is rarely available, and the long and costly treatment combined with a highly prevalent disorder result in insufficient access to evidence-based care.
The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient mentalization-based therapy for borderline personality disorder or subthreshold borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be assessed at trial intake using the Mini International Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for borderline personality disorder. Participants will be assessed blind to treatment allocation at baseline, and at 8, 16, and 24 months after randomization.
The primary outcome is severity of borderline symptomatology assessed using the Zanarini Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms and mentalization skills will be included as predictor and mediator variables.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •exclusive to the Outpatient Clinic
- •Age >18 years
- •Personality disorder(s) considered to be primary diagnosis/diagnoses
- •Inclusion Criteria exclusive to the trial:
- •A minimum of four DSM-5 criteria for borderline personality disorder
- •Written informed consent
排除标准
- •exclusive to the Outpatient Clinic:
- •Possibility of a learning disability (IQ<75)
- •A diagnosis of schizotypal personality disorder or antisocial personality disorder
- •Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
- •Current (past 2 months) substance dependance including alcohol
- •Concurrent psychotherapeutic treatment outside the clinic
- •Exclusion Criteria exclusive to the trial:
- •Lack of informed consent
结局指标
主要结局
Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview
时间窗: Assessed at baseline, and at 8, 16 and 24 months post-randomization
ZAN-BPD is an investigator-administered interview assessing change in severity of borderline personality disorder over time. Each of the nine DSM-5 criteria for borderline personality disorder are rated on a scale from 0-4, where 4 is the most severe, yielding a total score from 0-36.
次要结局
- Change in global functioning assessed with the Global Assessment of Functioning (GAF)(Assessed at baseline, and at 8, 16 and 24 months post-randomization)
- Change in amount of self-harm incidents(Assessed at baseline, and at 8, 16 and 24 months post-randomization)
- Change in functional impairmment assessed with the Work and Social Adjustment Scale (WSAS)(Assessed at baseline, and at 8, 16 and 24 months post-randomization)
- Change in quality of life assessed with the Short-Form Health Survey 36 (SF-36)(Assessed at baseline, and at 8, 16 and 24 months post-randomization)