Nordahl Hans M, Halvorsen Joar Øveraas, Hjemdal Odin, Ternava Mimoza Rrusta, Wells Adrian
St. Olavs Hospital HF, Nidaros DPS, P.O. Box 3250, 7006, Trondheim, Norway.
Institute of Mental Health, Faculty of Medicine and Health Sciences, NTNU, PO box 8905, 7491, Trondheim, Norway.
Trials. 2018 Jan 8;19(1):16. doi: 10.1186/s13063-017-2404-7.
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.
METHODS/DESIGN: 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.
对于重度创伤后应激障碍（PTSD）患者，心理治疗的首选方法是认知行为暴露疗法或眼动脱敏再处理疗法（EMDR）。虽然这些是最有效的治疗方法，但约30 - 45%的患者并无显著改善，且随访数据稀少。此外，一部分重度创伤患者因可能不堪重负而无法从暴露疗法中获益或避免接受该疗法。因此，有必要寻找无需暴露的有效方法。元认知疗法（MCT）是一种近期用于治疗PTSD的方法，无需暴露，具有潜在的强大治疗效果，但迄今为止尚未与EMDR进行比较。
方法/设计：本研究是一项双臂、平行、随机、优效性试验，比较MCT与EMDR的有效性。将纳入100例初步诊断为慢性PTSD的患者，他们将接受其中一种治疗的12次治疗。主要结局是治疗后（3个月）用创伤后诊断量表（PDS）评估的PTSD症状严重程度。次要结局包括3个月和12个月随访时的症状严重程度（PDS）以及焦虑、抑郁、元认知信念的测量指标。
这项随机研究是首次在12个月随访期内比较MCT与EMDR。该研究将表明MCT相对于EMDR的比较有效性以及在门诊临床环境中实施时效果的稳定性。
ClinicalTrials.gov，NCT01955590。于2013年9月24日注册。
