基于呼吸的冥想和认知加工疗法治疗退伍军人创伤后应激障碍症状的随机临床非劣效性试验。
Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans.
机构信息
War Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USA
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.
出版信息
BMJ Open. 2022 Aug 25;12(8):e056609. doi: 10.1136/bmjopen-2021-056609.
OBJECTIVE
Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.
SETTING
Outpatient Veterans Affairs healthcare centre.
PARTICIPANTS
85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study.
INTERVENTIONS
SKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks.
MEASURES
The primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS).
RESULTS
Mean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, -5.6, 0.41, n=41: CPT, -6.8, 0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (-1.2, 95% CI -5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT-SKY: -2.1, 95% CI -6.9 to 2.8) and 1-year (CPT-SKY: -1.8, 95% CI -6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54).
CONCLUSIONS
SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD.
TRIAL REGISTRATION NUMBER
NCT02366403.
目的
通过一项平行随机对照非劣效性试验，检验苏达尔山克里亚瑜伽（SKY）是否不劣于认知加工疗法（CPT）治疗退伍军人的创伤后应激障碍（PTSD）症状。
设置
退伍军人事务医疗中心的门诊。
参与者
85 名患有 PTSD 症状的退伍军人（75 名男性，61%为白人，平均年龄 56.9 岁）于 2015 年 10 月至 2020 年 3 月期间参加了研究：59 名参与者完成了研究。
干预措施
SKY 强调呼吸常规，在 15 小时的工作坊中以小组形式进行，然后每周进行两次 1 小时的课程，为期 5 周。CPT 是一种个体心理疗法，强调改变认知评估，并在两周内每周进行两次 1 小时的课程。
措施
主要结局测量指标是平民版 PTSD 检查表（PCL-C）。次要测量指标是贝克抑郁量表第二版（BDI-II）和正负情绪量表（PANAS）。
结果
基线时的平均 PCL-C 为 56.5（±12.6）。意向治疗分析显示，与基线相比，6 周（治疗结束时）PCL-C 评分降低（SKY，-5.6，0.41，n=41：CPT，-6.8，0.58，n=44）。治疗差异的变化评分在 10 分的非劣效性范围内（-1.2，95%置信区间-5.7 至 3.3），表明 SKY 不劣于 CPT。SKY 在 1 个月（CPT-SKY：-2.1，95%置信区间-6.9 至 2.8）和 1 年（CPT-SKY：-1.8，95%置信区间-6.6 至 2.9）评估中也不劣于 CPT。在治疗结束和 1 个月时，SKY 在 BDI-II 和 PANAS 上也不劣于 CPT，但在 1 年时，SKY 在 BDI-II 和 PANAS 上均劣于 CPT。辍学率相似（SKY，27%，CPT，34%：OR=1.36，95%置信区间 0.51 至 3.62，p=0.54）。
结论
SKY 可能不劣于 CPT 治疗 PTSD 症状，值得进一步考虑作为 PTSD 的治疗方法。
试验注册号
NCT02366403。
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