Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial
Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial
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DOI：
10.1089/acm.2020.0417
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发表时间：
2021-03-01
影响因子：
2.6
通讯作者：
Higgins, Melinda
中科院分区：
文献类型：
--
作者：
Kelly, Ursula;Haywood, Terri;Higgins, Melinda
目的：对一项正在进行的多地点随机临床试验（RCT）收集的数据进行中期分析，以评估创伤中心创伤敏感瑜伽（TCTSY）治疗与军事性创伤（MST）相关的创伤后应激障碍（PTSD）的女性退伍军人创伤后应激障碍（PTSD）的有效性。中期分析的目的是评估主站点的结果，主站点在地理上、人口统计学上、文化上和程序上都与第二站点不同。设计：随机对照试验在退伍军人管理局医疗保健系统内进行。数据收集包括干预前至干预后3个月。参与者：主要网站的注册人数为152名女性。意向治疗分析的样本量为104例。大多数是非裔美国人（91.3%），平均年龄48.46岁。干预：TCTSY干预（n = 58）由TCTSY认证的瑜伽辅导师进行，包括10个每周60分钟的小组会议。对照干预，认知加工治疗（CPT, n = 46），由临床医生在PTSD诊所按照退伍军人管理局的协议进行12次90分钟的每周小组会议。结果测量：DSM-5临床医师管理PTSD量表（CAPS-5）用于评估当前PTSD诊断和症状严重程度，包括总体PTSD和四个症状群。采用DSM-5 PTSD检查表（PCL-5）进行PTSD症状严重程度自我报告，包括总分和4个症状聚类。结果：本文报告的结果是来自一个临床站点的中期结果。在TCTSY组和CPT组中，cap -5和PCL-5的总得分和所有四个标准得分随时间的推移在所有五个多层线性模型中均显著下降（p < 0.01），组间无显著差异。TCTSY和CPT均有临床意义的改善，51.1%-64.3%的TCTSY受试者和43.5%-73.7%的CPT受试者的cap -5评分降低了10分或以上。TCTSY （Cohen’s d = 1.10-1.18）和CPT （Cohen’s d = 0.90-1.40）的总症状严重程度效应量较大。TCTSY组干预完成率（60.3%）高于CPT组（34.8%）。TCTSY组（干预中期）症状改善较CPT组（干预后2周）早。安全性：本研究未发生意外不良事件。结论：本研究结果表明TCTSY可能是一种有效的治疗创伤后应激障碍的方法，其症状改善速度更快，保留率高于CPT，且效果持续。TCTSY可能是一种有效的替代创伤治疗的女性退伍军人创伤后应激障碍相关的MST。该研究已在ClinicalTrials.gov注册(CTR号：: NCT02640690)。
Objective: To conduct an interim analysis of data collected from an ongoing multisite randomized clinical trial (RCT) assessing the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) for post-traumatic stress disorder (PTSD) among women veterans with PTSD related to military sexual trauma (MST). The purpose of the interim analysis was to assess outcomes from the primary site, which is geographically, demographically, culturally, and procedurally distinct from the second site.Design: RCT was conducted within a Veterans Administration Health Care System. Data collection included preintervention through 3 months postintervention.Participants: Enrollment for the main site was 152 women. The sample size for the intent-to-treat analysis was 104. The majority were African American (91.3%) with a mean age of 48.46 years.Intervention: The TCTSY intervention (n = 58) was conducted by TCTSY-certified yoga facilitators and consisted of 10 weekly 60-min group sessions. The control intervention, cognitive processing therapy (CPT; n = 46), consisted of 12 90-min weekly group sessions conducted per Veterans Administration protocol by clinicians in the PTSD Clinic.Outcome measures: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) was used to assess current PTSD diagnosis and symptom severity, including overall PTSD and four symptom clusters. The PTSD checklist for DSM-5 (PCL-5) was used to obtain self-report of PTSD symptom severity, including total score and four symptom clusters.Results: The findings reported here are interim results from one clinical site. For both the CAPS-5 and PCL-5, total scores and all four criterion scores decreased significantly (p < 0.01) over time in all five multilevel linear models within both TCTSY and CPT groups, without significant differences between groups. There were clinically meaningful improvements seen for both TCTSY and CPT with 51.1%-64.3% of TCTSY subjects and 43.5%-73.7% of CPT decreasing their CAPS-5 scores by 10 points or more. Effect sizes for total symptom severity were large for TCTSY (Cohen's d = 1.10-1.18) and CPT (Cohen's d = 0.90-1.40). Intervention completion was higher in TCTSY (60.3%) than in CPT (34.8%). Symptom improvement occurred earlier for TCTSY (midintervention) than for CPT (2 weeks postintervention).Safety: There were no unanticipated adverse events in this study.Conclusion: The results of this study demonstrate that TCTSY may be an effective treatment for PTSD that yields symptom improvement more quickly, has higher retention than CPT, and has a sustained effect. TCTSY may be an effective alternative to trauma-focused therapy for women veterans with PTSD related to MST.The study is registered in ClinicalTrials.gov (CTR no.: NCT02640690).