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

针对边缘型人格障碍（BPD）攻击行为（MAAP）的基于机制的团体心理治疗方法：一项多中心随机对照临床试验

• 批准号: 462340798
• 负责人: Professorin Dr. Sabine C. Herpertz
• 金额: --
• 依托单位: Klinik für Allgemeine Psychiatrie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/462340798?language=en
• 关键词: mechanism; based; group; psychotherapy; approach

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.

边缘性人格障碍（BPD）是一种常见且严重的精神障碍，普通人群的患病率约为1.7％，精神病患者的患病率为28％。在一年的时间里，多达80％的BPD患者从事侵略性行为，偶尔或经常参与身体战斗。尽管对受影响的人及其社交环境的燃烧量很高，但到目前为止，尚无针对侵略行为的具体成本效益的治疗方案。为了填补这一研究和治疗差距，我们针对小组设置开发了一种基于短期手动机制的抗攻击心理疗法（MAAP），该抗侵入疗法（MAAP）专门针对BPD的外部定向在BPD中使用辩证法 - 行为疗法（DBT）的验证技术（DBT）和基于心理化的疗法（MBT）。来自DFG资助的试验概念验证研究的数据表明，MAAP可能是具有侵略性问题的男性和男性患者的承诺治疗选择。因此，这项研究旨在调查这种新颖的8周小组心理疗法对“典型” BPD患者（关于发现的普遍性）在大型多中心（七个中心），群集融合的，观察者观察者的确认试验中，对同一剂量的对照组的攻击性对照组的攻击（七个中心）中对他人的侵略性行为（七个中心）表现出了攻击性行为。所有参与中心在治疗BPD患者方面均具有很高的专业知识，并且是否会参加患者参加实验组或对照组，将获得最高优先级。在假设MAAP对NSSPD的优势假设之后，我们计划包括n = 186例BPD和侵略性行为的患者，并选择了一种基于访谈的措施（公开的攻击量表，OAS-M），以评估公开侵略行为的频率和严重性，作为在6个月的随访中的主要结果，因此遵循了审阅者的建议。次要结果是生态瞬时评估（EMA）以及与生活质量和假定变化机制有关的测量。我们仔细遵循了试点研究的设计，尽管根据试点研究中患者的反馈，并收到了患者的支持。 MAAP ARM中主要结局度量在NSSP臂上的优势将通过随访时的公开攻击得分的线性混合模型作为因变量，预处理预处理的公开攻击分数作为协变量，中心和治疗组作为固定效应和治疗组作为随机效应，包括不同的敏感性分析。如果有优势，可以在心理保健服务中实施MAAP计划。