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）是一种常见的严重精神障碍，在普通人群中的患病率约为1.7%，在精神科住院患者中的患病率高达28%。高达80%的BPD患者在一年内有攻击性行为，超过50%的人偶尔或经常参与肢体冲突。尽管受影响的人以及他们的社会环境的高负担，没有具体的成本效益的治疗方案解决攻击性行为存在，到现在为止。为了填补这一研究和治疗空白，我们开发了一种短期的手动机制为基础的抗攻击心理治疗（MAAP）的组设置，专门针对外部定向攻击BPD使用验证技术从辩证行为疗法（DBT）和基于心理化的治疗（MBT）。来自DFG资助的试点概念验证研究的数据表明，MAAP可能是女性和男性攻击性问题患者的一种有希望的治疗选择。因此，本研究旨在通过一项大规模多中心（7个中心）、随机分组、观察者设盲的验证性试验，与相同剂量的活性对照组治疗非特异性支持性心理治疗（NSSP）相比，研究这种新型8周团体心理治疗对表现出攻击性行为的“典型”BPD患者（关于结果的普遍性）的疗效。所有参与研究的中心在治疗BPD患者方面都具有很高的专业知识，无论患者是否参加实验组或对照组，安全性都将被视为最优先考虑的问题。根据MAAP优于NSSPD的假设，我们计划纳入N=186例BPD和攻击行为患者，并选择了基于访谈的测量（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个月随访的主要结局，从而遵循了评审员的建议。次要结果亚生态瞬时评估（EMA）以及与生活质量和假设的变化机制相关的测量。我们密切关注试点研究的设计，尽管我们根据试点研究中患者的反馈改变了治疗方案的一些要素，并得到了患者代表的支持。将通过线性混合模型检验MAAP组相对于NSSP组的主要结局指标的优势，该模型将随访时的显性攻击评分作为因变量，治疗前显性攻击评分作为协变量，中心和治疗组作为固定效应，治疗组作为随机效应，包括不同的敏感性分析。在优越的情况下，MAAP方案可以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.