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Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial.
BMC Psychiatry ( IF 4.4 ) Pub Date : 2020-07-06 , DOI: 10.1186/s12888-020-02648-3
Franziska Miegel 1 , Cüneyt Demiralay 1 , Steffen Moritz 1 , Janina Wirtz 1 , Birgit Hottenrott 1 , Lena Jelinek 1
Affiliation  

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.

中文翻译:

强迫症的元认知训练:一项随机对照试验的研究方案。

大量强迫症 (OCD) 患者没有接受具有暴露和反应预防的认知行为治疗,这是治疗强迫症最有效的方法。因此,针对强迫症的元认知训练(MCT-OCD)应运而生,这是一种结构化的团体疗法,旨在改变功能失调的(元)认知偏见、信念和应对方式。它可以由训练有素的人员进行管理,因此可能会接触到更多的患者。一项不受控制的试点研究(MCT-OCD 试点版本)提供了第一个证据,证明培训被患者高度接受;OC 症状随着高效应量而减少(η2partial = 0.50)。本研究的目的是解决试点研究的缺点(例如,无对照组)并在随机对照试验的框架内评估修订版 MCT-OCD 的功效。将招募八十名强迫症患者。在基线(-t1)进行盲法评估后,患者将被随机分配到干预组(MCT-OCD;n = 40)或照常护理对照组(n = 40)。MCT-OCD 旨在通过解决与 OCD 相关的功能失调(元)认知偏差和信念(例如,对不确定性的不容忍),在八个模块中提高患者的元认知能力。8 周后,患者将被邀请进行后评估(t1),然后他们将在 t1 后 3 个月(t2)收到后续在线问卷调查。主要结果为 Y-BOCS 总分,次要结果包括 HDRS、OCI-R、OBQ-44、MCQ-30、WHOQOL-BREF、BDI-II、和 MCT-OCD 的主观评价等级。我们预计,从 –t1 到 t1,干预组的 OC 症状将比照常护理对照组减少更多,并且治疗收益将保持到 t2。计划中的研究是第一个在随机对照试验中调查 MCT-OCD 的研究,这是一种有前途的新疗法。MCT-OCD 可能有助于克服强迫症患者现有的治疗障碍。德国临床研究登记处 (DRKS00013539),2018 年 2 月 22 日。MCT-OCD 可能有助于克服强迫症患者现有的治疗障碍。德国临床研究登记处 (DRKS00013539),2018 年 2 月 22 日。MCT-OCD 可能有助于克服强迫症患者现有的治疗障碍。德国临床研究登记处 (DRKS00013539),2018 年 2 月 22 日。
更新日期:2020-07-06
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