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Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial

机译:元认知疗法与创伤后应激障碍的眼球运动脱敏和再处理:一项针对随机优势试验的研究方案

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The psychological treatment of choice for patients with severe posttraumatic stress disorder (PTSD) is cognitive behavioural exposure therapy or Eye Movement Desensitisation Reprocessing (EMDR). Whilst these are the most effective treatments, approximately 30–45% of the patients show no significant improvements and follow-up data are sparse. Furthermore, a proportion of patients with severe trauma does not benefit or avoid exposure therapy due to the potential to overwhelm them. Therefore, it is necessary to search for effective methods that do not require exposure. Metacognitive therapy (MCT), a recent treatment approach to PTSD that does not require exposure, has potential strong treatment effects but so far a comparison with EMDR has not been made. This study is a two-arm, parallel, randomized, superiority trial comparing the effectiveness of MCT with EMDR. One hundred patients with a primary diagnosis of chronic PTSD will be included and will receive 12 sessions of one of the treatments. The primary outcome is severity of PTSD symptoms assessed with the Posttraumatic Diagnostic Scale (PDS) measured post-treatment (3?months). Secondary outcomes include symptom severity (PDS) and measures of anxiety, depression, metacognitive beliefs at 3-month and 12-month follow up. This randomized study is the first to compare MCT with EMDR with 12-month follow-up. The study will indicate the comparative effectiveness of MCT against EMDR and the stability of effects when delivered in an outpatient clinical setting. ClinicalTrials.gov, NCT01955590 . Registered on 24 September 2013.
机译:重度创伤后应激障碍(PTSD)患者的心理治疗选择是认知行为暴露疗法或眼动脱敏再加工(EMDR)。尽管这些是最有效的治疗方法,但约30–45%的患者没有明显改善,随访数据稀疏。此外,由于可能使他们不堪重负,有一部分严重创伤的患者没有受益或避免接触治疗。因此,有必要寻找不需要暴露的有效方法。元认知疗法(MCT)是不需要暴露的PTSD的最新治疗方法,具有潜在的强大治疗效果,但到目前为止,尚未与EMDR进行比较。这项研究是一项两臂平行,随机,优越性试验,比较了MCT和EMDR的有效性。将包括100名初步诊断为慢性PTSD的患者,并将接受其中一种治疗方法的12个疗程。主要结果是用治疗后(3个月)测量的创伤后诊断量表(PDS)评估PTSD症状的严重程度。次要结果包括症状严重程度(PDS)以及在3个月和12个月的随访中对焦虑,抑郁,元认知信念的测量。这项随机研究是第一个将MCT与EMDR进行比较并进行12个月随访的研究。这项研究将表明MCT对EMDR的比较有效性以及在门诊临床环境中递送时效果的稳定性。 ClinicalTrials.gov,NCT01955590。 2013年9月24日注册。

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