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The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
Trials ( IF 2.5 ) Pub Date : 2024-04-15 , DOI: 10.1186/s13063-024-08095-9
Melissa G. A. Remeeus , Sharon L. Clarke , Dine J. Feenstra , Hester Van Eeren , Maaike L. Smits , Sara Debruyne , Mirjam E. J. Kouijzer , Patrick Luyten , Ron H. J. Scholte , Joost Hutsebaut

Although clinical guidelines prioritize the treatment of depression and anxiety in young persons, there is accumulating evidence that the presence of symptoms of borderline personality disorder (BPD) is associated with the limited effectiveness of these standard treatments. These findings stress the need for interventions addressing early-stage BPD in young people with presenting symptoms of anxiety and depressive disorders. The aim of this study is to investigate the (cost-)effectiveness of an early intervention programme for BPD (MBT-early) compared to first-choice psychological treatment for depression and anxiety according to Dutch treatment guidelines (CBT), in adolescents with either depression, anxiety, or both, in combination with early-stage BPD. This study is a multi-centre randomized controlled trial. A total of 132 adolescents, presenting with either depression, anxiety, or both and significant BPD features will be randomized to either MBT-early or CBT. The severity of BPD, symptoms of depression and anxiety, personality, social and academic functioning, and quality of life will be assessed at baseline, end of treatment, and at 12-, 18-, and 24-month follow-up, along with medical costs and costs of productivity losses for cost-effectiveness analyses. This study will provide an empirical evaluation of the potential surplus value of early intervention in young people for whom treatment oriented at common mental disorders like anxiety and depression may be insufficient given their underlying personality problems. Netherlands Trial Register, NL9569. Registered on June 15, 2021.

中文翻译:

早期干预 (MBT-early) 与标准方案治疗 (CBT) 对青少年新出现的边缘性人格障碍的(成本)有效性(早期研究):一项随机对照试验的研究方案

尽管临床指南优先治疗年轻人的抑郁和焦虑,但越来越多的证据表明,边缘性人格障碍(BPD)症状的存在与这些标准治疗的有限疗效有关。这些发现强调需要采取干预措施来解决出现焦虑和抑郁症症状的年轻人的早期 BPD。本研究的目的是调查 BPD 早期干预计划 (MBT-early) 与根据荷兰治疗指南 (CBT) 治疗抑郁和焦虑的首选心理治疗相比,对于患有以下任一症状的青少年的(成本)有效性抑郁、焦虑或两者兼而有之,并伴有早期 BPD。本研究是一项多中心随机对照试验。总共 132 名患有抑郁症、焦虑症或两者兼而有之且具有显着 BPD 特征的青少年将被随机分配接受早期 MBT 或 CBT。将在基线、治疗结束以及 12、18 和 24 个月的随访时评估 BPD 的严重程度、抑郁和焦虑症状、性格、社会和学业功能以及生活质量,并在医疗成本和生产力损失成本,以进行成本效益分析。这项研究将对年轻人早期干预的潜在剩余价值进行实证评估,鉴于他们潜在的人格问题,针对焦虑和抑郁等常见精神障碍的治疗可能是不够的。荷兰试验登记册,NL9569。注册于2021年6月15日。
更新日期:2024-04-15
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