Supplementary Material for: Interactive Motion-Assisted Exposure Therapy for Veterans with Treatment-Resistant Posttraumatic Stress Disorder: A Randomized Controlled Trial

Background: Veterans with posttraumatic stress disorder (PTSD) tend to benefit less from evidence-based treatments than other PTSD populations. A novel virtual reality and motion-assisted exposure therapy, called 3MDR, provides treatment in an immersive, personalized and activating context. Objective: To study the efficacy of 3MDR for veterans with treatment-resistant PTSD. Method: In a randomized controlled trial (n = 43) 3MDR was compared to a non-specific treatment component control group. Primary outcome was clinician-rated PTSD symptoms at baseline, after 3MDR, and at the 12-week and 16-week follow-up (primary end point). Intention-to-treat analyses of covariance and mixed models were applied to study differences between groups at the end point and over the course of intervention, controlling for baseline scores. Results: The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83). No significant between-group difference was detected in the course of PTSD symptoms during treatment when including all time points. The dropout rate was low (7%), and 45% of the patients in the 3MDR group improved clinically. The number needed to treat was 2.86. Conclusions: In this trial, 3MDR significantly decreased PTSD symptoms in veterans with, on average, a history of 4 unsuccessful treatments. The low dropout rate may be indicative of high engagement. However, a lack of significant differences on secondary outcomes limits conclusions that can be drawn on its efficacy and underlines the need for larger phase III trials. These data show emerging evidence for 3MDR and its potential to progress PTSD treatment for veterans (Dutch Trial Register Identifier: NL5126).背景：创伤后应激障碍（Posttraumatic Stress Disorder, PTSD）退伍军人患者从循证治疗中获益的程度通常低于其他PTSD人群。一种名为3MDR的新型虚拟现实结合运动辅助暴露疗法，可在沉浸式、个性化且具激活作用的场景中为患者提供治疗。 研究目的：探究3MDR针对难治性PTSD退伍军人的疗效。 研究方法：本研究为随机对照试验（样本量n=43），将3MDR与非特异性治疗组分对照组进行对比。主要结局指标为基线阶段、3MDR治疗结束时，以及12周、16周随访时（主要终点）临床医师评定的PTSD症状水平。本研究采用意向治疗协方差分析及混合效应模型，在控制基线得分的前提下，对比两组在主要终点时刻及干预全程的症状差异。 研究结果：相较于对照组，3MDR组从基线至主要终点的PTSD症状严重程度降幅显著更大，效应量处于较高水平（F[1, 37] = 6.43, p = 0.016, d = 0.83）。纳入所有时间点分析时，治疗期间两组PTSD症状的变化趋势未发现显著组间差异。本研究脱落率较低（7%），3MDR组中有45%的患者达到临床改善标准，需治疗人数为2.86。 研究结论：在本次试验中，对于平均具有4次失败治疗史的难治性PTSD退伍军人，3MDR可显著降低其PTSD症状水平。较低的脱落率提示患者具有较高的治疗依从性。然而，次要结局指标未观察到显著组间差异，这限制了本研究对其疗效的结论推导，并提示需开展更大规模的Ⅲ期临床试验。本研究数据为3MDR及其在退伍军人PTSD治疗领域的应用潜力提供了初步证据（荷兰试验注册库标识符：NL5126）。