Woud Marcella L, Blackwell Simon E, Cwik Jan C, Margraf Jürgen, Holmes Emily A, Steudte-Schmiedgen Susann, Herpertz Stephan, Kessler Henrik
Department of Psychology, Mental Health Research and Treatment Center, Ruhr-Universität Bochum, Bochum, Germany.
Department for Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
BMJ Open. 2018 Jun 30;8(6):e019964. doi: 10.1136/bmjopen-2017-019964.
Influential theories of post-traumatic stress disorder (PTSD) suggest that dysfunctional appraisals of trauma play a key role in the maintenance of symptoms, and this suggestion is increasingly supported by research. Experimental studies have indicated that a simple computerised cognitive training procedure, here termed cognitive bias modification-appraisals (CBM-App), can modify trauma-relevant appraisals and reduce analogue trauma symptoms among healthy volunteers. This suggests the possibility that CBM-App could improve outcomes in PTSD via targeting the key process of dysfunctional appraisals, for example, if applied as an adjunct to treatment.
The study is a randomised controlled trial with two parallel arms. It is planned to randomise 80 patients admitted for treatment for PTSD to an inpatient treatment clinic to complete either sessions of CBM-App or a sham-training control condition, the peripheral vision task. Both interventions comprise eight sessions scheduled over a 2-week period and are completed in addition to the standard treatment programme in the clinic. Outcome assessment occurs pretraining, after 1 week of training, post-training, at discharge from the inpatient clinic and 6 weeks and 3 months postdischarge. The primary outcome is dysfunctional trauma-relevant appraisals at post-training, measured using a scenario completion task. Secondary outcomes include symptom measures and hair cortisol. Outcome analyses will be primarily via mixed linear models and conducted with both intention to treat and per protocol samples.
The trial has been approved by the Ethics Committee for the Faculty of Psychology, Ruhr-Universität Bochum (approval no 204) and the Ethics Committee for the Faculty of Medicine, Ruhr-Universität Bochum (approval no 15-5477). Results will be published in peer-reviewed journals and will inform future clinical and experimental studies into targeting maladaptive appraisals for the reduction of PTSD symptoms.
NCT02687555.
创伤后应激障碍（PTSD）的相关理论表明，对创伤的功能失调性认知评估在症状维持中起关键作用，这一观点越来越得到研究的支持。实验研究表明，一种简单的计算机化认知训练程序，在此称为认知偏差修正评估（CBM-App），可以改变与创伤相关的评估，并减轻健康志愿者的模拟创伤症状。这表明CBM-App有可能通过针对功能失调性评估的关键过程来改善PTSD的治疗效果，例如，作为治疗的辅助手段应用时。
本研究是一项双臂平行随机对照试验。计划将80名因PTSD入院治疗的患者随机分配到一家住院治疗诊所，使其完成CBM-App训练课程或假训练对照条件，即周边视觉任务。两种干预措施均包括在两周内安排的八次课程，且在诊所的标准治疗方案之外完成。在训练前、训练1周后、训练后、住院诊所出院时以及出院后6周和3个月进行结果评估。主要结果是训练后的功能失调性创伤相关评估，使用情景完成任务进行测量。次要结果包括症状测量和头发皮质醇。结果分析将主要通过混合线性模型进行，并对意向性治疗样本和符合方案样本进行分析。
该试验已获得波鸿鲁尔大学心理学院伦理委员会（批准号204）和波鸿鲁尔大学医学院伦理委员会（批准号15-5477）的批准。研究结果将发表在同行评审期刊上，并将为未来针对减少PTSD症状的适应性不良评估的临床和实验研究提供参考。
NCT02687555。
