认知人际治疗与结构化临床模型的神经生物学和临床效果比较：一项随机对照试验研究方案。

Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial.

机构信息

Unit of Psychiatry, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.

Third Centre of Cognitive Psychotherapy, Rome, Italy.

出版信息

BMC Psychiatry. 2019 Jun 24;19(1):195. doi: 10.1186/s12888-019-2127-2.

DOI:10.1186/s12888-019-2127-2

PMID:31234864

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6591903/

Abstract

BACKGROUND

Borderline Personality Disorder (BPD) is a complex and debilitating disorder, characterized by deficits in metacognition and emotion dysregulation. The "gold standard" treatment for this disorder is psychotherapy with pharmacotherapy as an adjunctive treatment to target state symptoms. The present randomized clinical trial aims to assess the clinical and neurobiological changes following Metacognitive Interpersonal Therapy (MIT) compared with Structured Clinical Management (SCM) derived from specific recommendations in APA (American Psychiatric Association) guidelines for BPD.

METHODS

The study design is a randomized parallel controlled clinical trial and will include 80 BPD outpatients, aged 18-45 enrolled at 2 recruitment centers. Primary outcome will be the clinical change in emotion regulation capacities assessed with the Difficulties in Emotion Regulation Scale (DERS). We will also investigated the effect of psychotherapy on metacognitive abilities and several clinical features such as BPD symptomatology, general psychopathology, depression, personal functioning, and trait dimensions (anger, impulsivity, alexithymia). We will evaluate changes in brain connectivity patterns and during the view of emotional pictures. A multidimensional assessment will be performed at the baseline, at 6, 12, 18 months. We will obtain structural and functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N = 30) and SCM-treated BPD (N = 30) at baseline and after treatment, as well as in a group of 30 healthy and unrelated volunteers that will be scanned once for comparison.

DISCUSSION

The present study could contribute to elucidate the neurobiological mechanisms underlying psychotherapy efficacy. The inclusion of a multidisciplinary study protocol will allow to study BPD considering different features that can affect the treatment response and their reciprocal relationships.

TRIAL REGISTRATION

NCT02370316 . Registered 02/24/2015.

摘要

背景

边缘型人格障碍（BPD）是一种复杂且使人虚弱的障碍，其特征是元认知和情绪调节能力缺陷。这种障碍的“金标准”治疗方法是心理治疗，药物治疗作为辅助治疗针对的是状态症状。本随机临床试验旨在评估与结构临床管理（SCM）相比，元认知人际治疗（MIT）治疗后的临床和神经生物学变化，SCM 源自 APA（美国精神病学协会）BPD 指南中的具体建议。

方法

研究设计为随机平行对照临床试验，将包括 2 个招募中心招募的 80 名 18-45 岁的 BPD 门诊患者。主要结局是使用情绪调节困难量表（DERS）评估的情绪调节能力的临床变化。我们还研究了心理治疗对元认知能力以及 BPD 症状、一般精神病理学、抑郁、个人功能和特质维度（愤怒、冲动、述情障碍）等几个临床特征的影响。我们将评估治疗前后大脑连接模式和观看情绪图片时的变化。基线、6 个月、12 个月和 18 个月时将进行多维评估。我们将在基线、治疗后以及在与治疗无关的 30 名健康志愿者中获得 MIT 治疗的 BPD（N=30）和 SCM 治疗的 BPD（N=30）的结构和功能磁共振成像（MRI），并且志愿者将只扫描一次进行比较。