War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA.
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.
BMJ Open. 2019 Apr 3;9(4):e027150. doi: 10.1136/bmjopen-2018-027150.
Post-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind-body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation.
We present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the 'last observation carried forward' for missing data) and a per-protocol or 'treatment completers' procedure, which is the most rigorous approach to non-inferiority designs.
To the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD.
NCT02366403; Pre-results.
创伤后应激障碍（PTSD）是一种使人衰弱且普遍存在的疾病。目前的临床实践指南建议将以创伤为中心的心理疗法（例如，认知加工疗法；CPT）作为 PTSD 的一线治疗方法。然而，尽管这些治疗方法显示出具有临床意义的症状改善，但大多数开始治疗的人在治疗后仍保留 PTSD 的诊断。也许正因如此，许多患有 PTSD 的人寻求更全面、身心一体、补充和综合健康（CIH）干预措施。然而，对于 PTSD 的 CIH 干预措施，仍然缺乏高质量的、积极对照的疗效研究，这使得它们无法得到正式推荐。
我们介绍了一项正在进行的非劣效性平行组随机对照试验（RCT）的方案，该试验比较了呼吸冥想干预（苏达尔山克里亚瑜伽[SKY]）与 PTSD 推荐的循证心理疗法（CPT）在退伍军人中的疗效。评估者对治疗组不知情。主要结局指标是创伤后应激障碍检查表-平民版，以及一系列临床、自我报告、实验和生理结局指标，评估每个 PTSD 症状群（再体验、回避、消极认知或情绪和过度警觉/反应）的治疗相关变化。一旦 RCT 完成，分析将同时使用意向治疗（使用“最后一次观察结转”处理缺失数据）和“方案治疗完成者”或“治疗完成者”程序，这是最严格的非劣效性设计方法。
据我们所知，这是 SKY 与 PTSD 退伍军人 CPT 的首次非劣效性 RCT。该方案已获得斯坦福大学机构审查委员会的批准。所有参与者在参与之前都提供了书面知情同意。这项 RCT 的结果将为未来的研究提供信息，包括更大规模的 PTSD 多中心 SKY 疗效 RCT 以及其他心理健康状况的研究，以及探索成本效益和评估实施问题。结果还将为 PTSD 的 CIH 干预措施提供循证的正式建议。
NCT02366403；预结果。
