大量强迫症(OCD)患者没有接受暴露和反应预防的认知行为治疗,这是强迫症最有效的治疗方法。因此,OCD的元认知训练(MCT-OCD)被开发出来,这是一种结构化的团体疗法,旨在改善功能失调(元)认知偏见,信仰和应对方式。它可以由训练有素的人员管理,因此可能达到更多的患者。一项不受控制的先导研究(MCT-OCD先导版)提供了第一个证据,表明该训练已被患者高度接受;OC症状降低,效果较高(η2部分=0.50)。本研究的目的是解决试点研究的缺点(例如,无对照组),并在随机对照试验框架内评估MCT-OCD修订版的疗效。
将招募80名强迫症患者。在基线(-t1)进行盲法评估后,患者将被随机分配至干预组(MCT-OCD;n=40)或照常治疗对照组(n=40).MCT-OCD旨在通过解决与OCD相关的功能失调(元)认知偏见和信念来提高八个模块中患者的元认知能力(例如,不容忍不确定性)。8周后,患者将被邀请参加后期评估(t1),然后他们将在t1(t2)后3个月收到一份后续在线问卷。主要结果是Y-BOCS总分,次要结果包括HDRS,OCI-R,OBQ-44,MCQ-30,WHOQOL-BREF,BDI-II,以及MCT-OCD的主观评价等级。我们预计从-t1到t1,与照常护理对照组相比,干预组的OC症状将减少更多,并且治疗收益将保持到t2。
计划中的研究是第一个研究MCT-OCD,一种有希望的新疗法,在一项随机对照试验中。MCT-OCD可能有助于克服OCD患者的现有治疗障碍。
德国临床研究注册中心(DRKS00013539),22.02.2018.
A high number of patients with obsessive-compulsive disorder (OCD) do not receive cognitive-behavioral therapy with exposure and response prevention, which is the most effective treatment for OCD. Therefore, Metacognitive Training for OCD (MCT-OCD) was developed, which is a structured group therapy aiming at the modification of dysfunctional (meta-)cognitive
biases, beliefs and coping styles. It can be administered by less trained personnel, thus may reach a higher number of patients. An uncontrolled pilot study (MCT-OCD pilot version) provided first evidence that the training is highly accepted by patients; OC symptoms decreased with a high effect size (η2partial = 0.50). The aim of the present
study is to address the shortcomings of the pilot
study (e.g., no control group) and to assess the efficacy of the revised version of the MCT-OCD in the framework of a randomized controlled
trial.
Eighty patients with OCD will be recruited. After a blinded assessment at baseline (-t1), patients will be randomly assigned either to the intervention group (MCT-OCD; n = 40) or to a care as usual control group (n = 40). The MCT-OCD aims to enhance patients\' metacognitive competence in eight modules by addressing dysfunctional (meta-)cognitive
biases and beliefs associated with OCD (e.g., intolerance of uncertainty). After 8 weeks, patients will be invited to a post assessment (t1), and then they will receive a follow-up online questionnaire 3 months following t1 (t2). The primary outcome is the Y-BOCS total score, and the secondary outcomes include the HDRS, OCI-R, OBQ-44, MCQ-30, WHOQOL-BREF, BDI-II, and subjective appraisal ratings of the MCT-OCD. We expect that OC symptoms will decrease more in the intervention group compared with the care as usual control group from -t1 to t1 and that treatment gains will be maintained until t2.
The planned study is the first to investigate the MCT-OCD, a promising new treatment, in a randomized controlled
trial. The MCT-OCD may help to overcome existing treatment barriers for patients with OCD.
German Registry for Clinical Studies ( DRKS00013539 ), 22.02.2018.