A mechanism-based group-psychotherapy approach to aggressive behavior (MAAP) in borderline personality disorder (BPD): a multicenter randomized controlled clinical trial

边缘型人格障碍（BPD）是一种常见且严重的精神障碍，在一般人群中患病率约为1.7%，在精神科住院患者中患病率高达28%。高达80%的BPD患者在一年的时间里有攻击性行为，超过50%的人偶尔或经常参与身体打架。尽管受影响的人及其社会环境负担沉重，但到目前为止，还没有针对攻击行为的具体经济有效的治疗方案。为了填补这一研究和治疗空白，我们开发了一种短期的基于机制的反攻击心理治疗（MAAP），专门针对BPD的外部定向攻击，使用了辩证行为疗法（DBT）和基于心理疗法（MBT）的验证技术。来自dfg资助的试点概念验证研究的数据表明，MAAP可能是有攻击性问题的女性和男性患者的一种有希望的治疗选择。因此，本研究旨在通过一项更大规模的多中心（7个中心）、集群随机、观察盲法验证性试验，研究这种为期8周的新型团体心理治疗对表现出攻击行为的“典型”BPD患者（关于结果的普遍性）的疗效，并与使用相同剂量的积极对照组非特异性支持性心理治疗（NSSP）进行对照。所有参与的中心在治疗BPD患者方面都有很高的专业知识，无论患者是参加实验组还是对照组，安全性都将被优先考虑。根据MAAP优于NSSPD的假设，我们计划纳入N=186名有BPD和攻击行为的患者，并选择了一种基于访谈的测量方法（显性攻击量表，OAS-M）来评估显性攻击行为的频率和严重程度，作为6个月随访的主要结果，因此遵循了评审者的建议。次要结果包括生态瞬时评估（EMA）以及与生活质量和假设的变化机制相关的测量。我们密切遵循试点研究的设计，尽管我们根据试点研究中患者的反馈并得到患者代表的支持，改变了治疗方案的一些元素。MAAP组的主要结局指标相对于NSSP组的优势将通过线性混合模型进行检验，该模型以随访时的显性攻击得分为因变量，治疗前的显性攻击得分为协变量，中心和治疗组为固定效应，治疗组为随机效应，包括不同的敏感性分析。在有优势的情况下，MAAP计划可在精神卫生保健服务中实施。

Borderline personality disorder (BPD) is a common and severe mental disorder with prevalence rates of about 1.7 % in the general population and up to 28% in psychiatric inpatients. Up to 80% of individuals with BPD have engaged in aggressive behaviors over the course of a year and more than 50% are occasionally or often involved in physical fights. Despite the high burden for people affected as well as their social surroundings, no specific cost-effective treatment options addressing aggressive behavior exist, up to now. To fill this research and treatment gap, we developed a short-term manualized Mechanism-based Anti-Aggression Psychotherapy (MAAP) for the group setting which specifically targets externally directed aggression in BPD using validated techniques from Dialectic-Behavior Therapy (DBT) and Mentalization-Based Therapy (MBT). Data from a DFG-funded pilot proof-of-concept study suggest that MAAP might be a promising therapy option for female and male patients with aggressive problems. Consequently, this study aims to investigate the efficacy of this novel 8-week group psychotherapy for “typical” BPD patients (with regard to generalizability of findings) showing aggressive behavior against others in a larger-scale multicenter (seven centers), cluster-randomized, observer blinded confirmatory trial against an active control group treatment of the same dosage, Non-Specific Supportive Psychotherapy (NSSP). All participating centers have high expertise in treating patients with BPD and safety will be given highest priority whether patients will participate in the experimental or control group. Following the hypothesis of a superiority of MAAP against NSSPD we plan to include N=186 patients with BPD and aggressive behaviors and have selected an interview-based measure (Overt Aggression Scale, OAS-M) to assess frequency and severity of overt aggressive behavior as primary outcome at 6-months follow-up and thereby have followed the reviewers´ suggestions. Secondary outcomes subsume ecological momentary assessment (EMA) as well as measurements related to quality of life and assumed mechanisms of change. We closely follow the design of the pilot study although we have changed some elements of the therapy program according to patients´ feedback in the pilot study and having received support from patients’ representatives. Superiority of the primary outcome measure in the MAAP arm over the NSSP arm will be tested by a linear mixed model of overt aggression score at follow-up as the dependent variable, pre-treatment overt aggression score as a covariate, center and treatment arm as fixed effects and therapy group as random effect, including different sensitivity analyses. In case of superiority the MAAP program can be implemented in mental health care services.