MRI acquisition parameters.

Borderline personality disorder (BPD) is a severe psychiatric condition associated with high rates of suicide and poor interpersonal functioning. There are no FDA-approved medications, and evidence-based psychotherapies such as dialectical behavior therapy (DBT) are difficult to access and vulnerable to patient dropout. Novel treatment directions are urgently needed. Mindfulness is the core skill in DBT. Our team has developed a mindfulness-based real-time neurofeedback (mbNF) paradigm where individuals learn to reduce default mode network (DMN) versus control network activation in order to increase present-moment awareness. Here, we describe the study protocol for the MIndfulness-based Neurofeedback to Augment DBT Psychotherapy for Borderline Personality Disorder (MIND-BPD) trial. Participants with BPD (N = 52) enrolled in the study will be randomly assigned (1:1 ratio) to receive one session of either real or sham mbNF. Following neurofeedback, all participants will be enrolled in a 6-month DBT psychotherapy group. Supported by a R61/R33 grant from the NIH, the primary outcome of the R61 phase of this trial is change in DMN connectivity between pre- and post-NF resting-state scans, as defined by increased within-network connectivity between the medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC), and increased connectivity between the mPFC and dorsolateral prefrontal coftex (dlPFC). Change in self-reported mindfulness between pre- and post-NF is a key secondary outcome. This study is registered in the US Clinical Trials Registry (NCT06446765).

边缘型人格障碍（Borderline Personality Disorder，BPD）是一种严重的精神疾病，与高自杀率及不良人际功能密切相关。目前尚无美国食品药品监督管理局（Food and Drug Administration，FDA）获批的治疗药物，且辩证行为疗法（Dialectical Behavior Therapy，DBT）等循证心理治疗手段难以获取，同时患者脱落率较高，因此亟需探索新型治疗方向。正念是辩证行为疗法的核心技能。本团队已开发出基于正念的实时神经反馈（Mindfulness-based Real-time Neurofeedback，mbNF）范式，受试者可通过该范式学习降低默认模式网络（Default Mode Network，DMN）相较于对照网络的激活水平，以提升当下觉知能力。本文介绍了针对边缘型人格障碍的基于正念神经反馈辅助辩证行为疗法临床试验（MIND-BPD）的研究方案。本研究纳入52名边缘型人格障碍受试者，将按照1:1的比例随机分配至真实mbNF组或假mbNF组。完成神经反馈干预后，所有受试者将参与为期6个月的辩证行为疗法团体治疗。本研究获得美国国立卫生研究院（National Institutes of Health，NIH）R61/R33项目资助，该试验R61阶段的主要结局指标为神经反馈前后静息态扫描的默认模式网络连接变化，具体定义为内侧前额叶皮层（Medial Prefrontal Cortex，mPFC）与后扣带回皮层（Posterior Cingulate Cortex，PCC）之间的网络内连接增强，以及内侧前额叶皮层与背外侧前额叶皮层（Dorsolateral Prefrontal Cortex，dlPFC）之间的连接增强。神经反馈前后自我报告的正念水平变化为关键次要结局指标。本研究已在美国临床试验注册库（United States Clinical Trials Registry）注册，注册号为NCT06446765。