A modular add-on approach for patients with comorbid depression and a history of childhood maltreatment

针对患有共病抑郁症和有儿童虐待史的患者的模块化附加方法

• 批准号: 416580307
• 负责人: Professorin Dr. Elisabeth Schramm, Ph.D.
• 金额: --
• 依托单位: Klinik für Allgemeine Psychiatrie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2020
• 资助国家: 德国
• 起止时间: 2019-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/416580307?language=en
• 关键词: modular; add; approach; patients; comorbid

While disorder-specific approaches for the treatment of depression have proven efficacy, there is a large proportion of patients not reaching response or remission most likely due to the inter-individual heterogeneity of etiological mechanisms of depression. In addition, there is a high rate of comorbid disorders in depression, particularly in patients with early abuse or neglect, which is not addressed by disorder-specific methods. A promising approach to address those issues is to complement interventions for depression by circumscribed psychotherapy modules targeting typical dysfunctions in a transdiagnostic way. Depending upon the patients’ presenting problems and disturbed functions, specific modules are selected. Thus, the intervention is more flexible and personalized than traditional standardized treatment. The Modular Based Psychotherapy (MBP) model proposed here complements standard Cognitive Behavioral Therapy (CBT) for depression with modules compiling specific strategies from Cognitive Behavioral Analysis System of Psychotherapy, mentalization-based therapy, and mindfulness-based treatment, all supported by previous trials. The modules focus on three disturbed systems critically related to childhood maltreatment: the negative valence system (acute, potential, and sustained threat), the system of social processes (understanding mental states), and the arousal system (emotion awareness and emotional regulation). The aim of this bi-centric study is to assess whether in patients with comorbid depression and childhood maltreatment an individual treatment with CBT+MBP is superior to standard CBT in reducing depressive symptoms. Seventy outpatients with episodic or persistent major depression, comorbidity on axis I and/or II, and a history of childhood maltreatment will be randomized to either 20 individual sessions of CBT+MBP or 20 individual sessions of standard CBT over 16 weeks. Additional treatment with SSRI or SNRI is allowed if medication has been stable for at least four weeks before randomization. The primary hypothesis is that MBP as an add-on module to standard CBT is more effective than standard CBT alone in reducing depressive symptoms after 16 weeks of treatment.

虽然用于治疗抑郁症的疾病特异性方法已被证明有效，但很大一部分患者未达到应答或缓解，这很可能是由于抑郁症病因机制的个体间异质性。此外，抑郁症的共病率很高，特别是在早期虐待或忽视的患者中，这不是通过疾病特异性方法来解决的。解决这些问题的一个有希望的方法是通过以转诊断方式针对典型功能障碍的限定心理治疗模块来补充抑郁症的干预措施。根据患者的问题和功能障碍，选择特定的模块。因此，干预比传统的标准化治疗更灵活和个性化。这里提出的模块化心理治疗（MBP）模型补充了抑郁症的标准认知行为治疗（CBT），模块汇编了心理治疗的认知行为分析系统，基于心理化的治疗和基于正念的治疗的具体策略，所有这些都得到了以前试验的支持。这些模块侧重于与儿童虐待密切相关的三个干扰系统：负价系统（急性，潜在和持续的威胁），社会过程系统（理解心理状态）和唤醒系统（情绪意识和情绪调节）。这项双中心研究的目的是评估在患有共病抑郁症和儿童期虐待的患者中，CBT+MBP的个体治疗在减轻抑郁症状方面是否上级标准CBT。70名患有发作性或持续性重度抑郁症、轴I和/或II共病以及儿童期虐待史的门诊患者将随机接受20次CBT+MBP治疗或20次标准CBT治疗，持续16周。如果药物在随机化前至少4周稳定，则允许使用SSRI或SNRI进行额外治疗。主要假设是，MBP作为标准CBT的附加模块，在治疗16周后，在减少抑郁症状方面比单独使用标准CBT更有效。