经颅磁刺激联合辩证行为疗法治疗边缘型人格障碍的随机、单盲、安慰剂对照初步试验研究方法及设计。
Theta burst stimulation add on to dialectical behavioral therapy in borderline-personality-disorder: methods and design of a randomized, single-blind, placebo-controlled pilot trial.
机构信息
Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.
Department of Psychiatry and Psychotherapy, University Hospital of Psychiatry and Psychotherapy, Tübingen, Germany.
出版信息
Eur Arch Psychiatry Clin Neurosci. 2024 Feb;274(1):87-96. doi: 10.1007/s00406-023-01692-w. Epub 2023 Sep 15.
Specialized psychotherapeutic treatments like dialectical behavioral therapy (DBT) are recommended as first treatment for borderline personality disorder (BPD). In recent years, studies have emerged that focus on repetitive transcranial magnetic stimulation (rTMS) in BPD. Both have independently demonstrated efficacy in the treatment of BPD. Intermitted theta burst stimulation (iTBS), a modified design of rTMS, is thought to increase the excitability of neurons and could be a supplement to psychotherapy in addition to being a standalone treatment. However, no studies to date have investigated the combination of DBT and rTMS/iTBS. This study protocol describes the methods and design of a randomized, single-blinded, sham-controlled clinical pilot study in which BPD patients will be randomly assigned to either iTBS or sham during four consecutive weeks (20 sessions in total) in addition to standardized DBT treatment. The stimulation will focus on the unilateral stimulation of the left dorsolateral prefrontal cortex (DLPFC), which plays an important role in the control of impulsivity and risk-taking. Primary outcome is the difference in borderline symptomatology, while secondary target criteria are depressive symptoms, general functional level, impulsivity and self-compassion. Statistical analysis of therapy response will be conducted by Mixed Model Repeated Measurement using a 2 × 2-factorial between-subjects design with the between-subject factor stimulation (TMS vs. Sham) and the within-subject factor time (T0 vs. T1). Furthermore, structural magnetic resonance imaging (MRI) will be conducted and analyzed. The study will provide evidence and insight on whether iTBS has an enhancing effect as add-on to DBT in BPD.Trial registration: drks.de (DRKS00020413) registered 13/01/2020.
专门的心理治疗方法,如辩证行为疗法(DBT),被推荐作为边缘型人格障碍(BPD)的首选治疗方法。近年来,有研究聚焦于重复经颅磁刺激(rTMS)在 BPD 中的应用。这两种方法在 BPD 的治疗中都独立显示出了疗效。间歇性 theta 爆发刺激(iTBS)是 rTMS 的一种改良设计,被认为可以增加神经元的兴奋性,除了作为独立的治疗方法之外,还可以作为心理治疗的补充。然而,迄今为止,尚无研究探讨 DBT 和 rTMS/iTBS 的联合应用。本研究方案描述了一项随机、单盲、假对照临床试点研究的方法和设计,该研究将 BPD 患者随机分为 iTBS 或假刺激组,在连续四周(共 20 次)内接受标准 DBT 治疗的同时接受 rTMS/iTBS 治疗。刺激将集中在左侧背外侧前额叶皮层(DLPFC)的单侧刺激上,该区域在控制冲动和冒险行为方面起着重要作用。主要结局是边缘症状的差异,次要目标标准是抑郁症状、一般功能水平、冲动和自我同情。治疗反应的统计分析将通过混合模型重复测量进行,采用 2×2 因子被试间设计,其中被试间因子为刺激(TMS 与假刺激),被试内因子为时间(T0 与 T1)。此外,还将进行并分析结构磁共振成像(MRI)。该研究将提供证据和见解,说明 iTBS 是否作为 BPD 的 DBT 附加治疗具有增强作用。
试验注册
drks.de(DRKS00020413)于 2020 年 1 月 13 日注册。