Juul Sophie, McMain Shelley, Olsen Markus Harboe, Chapman Alexander, Pereira Ribeiro Johanne, Storebø Ole Jakob, Kuo Janice, Hestbaek Emilie, Kamp Caroline Barkholt, Rishede Marie, Frandsen Frederik Weischer, Bo Sune, Poulsen Stig, Sørensen Per, Bateman Anthony, Simonsen Sebastian, Jakobsen Janus C
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Mental Health Centre Stolpegaard, Copenhagen University Hospital - Mental Health Services, Copenhagen, Denmark.
BMJ Open. 2025 Sep 2;15(9):e096436. doi: 10.1136/bmjopen-2024-096436.
The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.
An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0-49 compared with 50-100).
The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.
CRD42024612840.
关于边缘性人格障碍（BPD）心理治疗的最佳疗程的证据很少。之前有两项试验比较了不同疗程的心理治疗。第一项试验比较了针对BPD的6个月与12个月的辩证行为疗法（FASTER试验）。第二项试验比较了针对BPD的5个月与14个月的基于心智化的疗法（MBT-RCT试验）。本研究的主要目的是通过合并FASTER试验和MBT-RCT试验中的两个短期组和两个长期组，对两项随机临床试验进行个体患者数据汇总分析，从而提供比单个试验更强的统计效力。因此，我们将评估关于BPD短期与长期心理治疗效果的总体证据，并调查某些亚组是否可能从短期与长期心理治疗中获益。
将对FASTER试验和MBT-RCT试验进行个体患者数据汇总分析。主要结局将是有自杀、自杀未遂或精神病住院的参与者比例的综合指标。次要结局将是有自我伤害行为的参与者比例。探索性结局将是BPD症状、症状困扰、功能水平和生活质量。我们将主要在FASTER试验随机分组后15个月以及MBT-RCT试验随机分组后16个月评估结局。将根据原始试验中的设计变量对预先定义的亚组进行如下干预交互检验：试验、性别（男性与女性）、年龄（30岁及以下与30岁以上）以及功能基线水平（功能总体评定基线评分在0 - 49与50 - 100之间）。
统计分析将对已由最初评估所纳入试验的各自伦理委员会批准的匿名试验数据进行。最终分析将发表在同行评审的科学期刊上，结果将在全国研讨会和国际会议上展示。
PROSPERO注册号：CRD42024612840。
