Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial.

Yoga vs Cognitive Processing Therapy for Military Sexual Trauma-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial.
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DOI:
10.1001/jamanetworkopen.2023.44862
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发表时间:
2023-12-01
期刊:
影响因子:
13.8
通讯作者:
Kelly, Ursula A.
Kelly, Ursula A.
中科院分区:
医学1区
文献类型:
--
作者:
Zaccari, Belle;Higgins, Melinda;Haywood, Terri N.;Patel, Meghna;Emerson, David;Hubbard, Kimberly;Loftis, Jennifer M.;Kelly, Ursula A.

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创伤中心创伤敏感瑜伽(TCTSY)与一线认知加工疗法(CPT)相比,对女性退伍军人与军事性创伤相关的创伤后应激障碍(PTSD)的有效性如何?在这项随机临床试验中,131名患有创伤后应激障碍的女性退伍军人使用美国退伍军人事务部医疗保健,TCTSY具有较大的组内效应量,与CPT等效,治疗完成率比CPT高42.6%。研究结果表明,TCTSY是一种具有成本效益的手段,可以扩大退伍军人事务部PTSD治疗选择;增加女性退伍军人获得可接受的,患者驱动的和有效的PTSD治疗的机会;并提供一种治疗选择,可以改善相关症状(例如,抑郁,焦虑)。这项随机临床试验评估了创伤敏感瑜伽与认知处理疗法对患有军事性创伤相关创伤后应激障碍(PTSD)的女性退伍军人的有效性。美国退伍军人事务部(VA)的创伤后应激障碍(PTSD)的一线治疗,即以创伤为中心的治疗,虽然有效,但受到低治疗启动率,高脱落率和高治疗折射率的限制。评估创伤中心创伤敏感瑜伽(TCTSY)与一线认知加工疗法(CPT)在患有与军事性创伤(MST)相关的创伤后应激障碍(PTSD)的女性退伍军人中的有效性,以及PTSD结局在干预措施之间存在差异的假设。这项多中心随机临床试验于2015年12月1日至2022年4月30日在位于东南部和西北部的2个VA医疗保健系统内进行。年龄在22至71岁的女性退伍军人与MST相关的创伤后应激障碍被招募,并随机分为TCTSY或CPT。TCTSY干预(专注于内感受和赋权的哈塔式瑜伽)包括每周10次,60分钟的小组会议,CPT干预(以认知为基础的治疗,旨在改变创伤后消极思想)包括每周12次,90分钟的小组会议。通过自我报告调查收集社会人口学数据。采用临床医生-管理者PTSD量表DSM-5(CAPS-5)和PTSD量表DSM-5(PCL-5)评估主要结局(PTSD症状严重程度)。在基线、干预中期、干预后2周和干预后3个月进行评估。在200名同意参加的女性退伍军人中,意向治疗样本包括131名参与者(平均[SD]年龄,48.2 [11.2]岁),其中72名随机分配到TCTSY,59名随机分配到CPT。TCTSY组有47名参与者(65.3%)完成了治疗,CPT组有27名参与者(45.8%)完成了治疗,TCTSY组的治疗完成率高出42.6%(P = 0.03)。两个治疗组的CAPS-5评分均随时间推移而改善(基线时平均[SD]评分:TCTSY为36.73 [8.79],CPT为35.52 [7.49]; 3个月时平均[SD]评分:TCTSY为24.03 [11.55],CPT为22.15 [13.56])和PCL-5(基线平均[SD]评分:TCTSY为49.62 [12.19],CPT为48.69 [13.62]; 3个月平均[SD]评分:TCTSY为36.97 [17.74],CPT为31.76 [12.47])(时间效应P < .001)。组效应或组-时间效应均不显著。TCTSY组和CPT组之间变化评分的等效性分析无显著差异,并且对于所有随访时间点,CAPS-5的两个单侧检验间隔均在± 10的等效性界限内。在这项比较有效性的随机临床试验中,TCTSY在减轻PTSD症状严重程度方面与CPT相当,两组都有显着改善。TCTSY的较高治疗完成率表明其作为与MST相关的PTSD女性退伍军人的有效和可接受的PTSD治疗的可接受性较高,可以解决当前VA PTSD治疗的局限性。ClinicalTrials.gov标识符:NCT 02640690
What is the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) compared with first-line cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) related to military sexual trauma in women veterans? In this randomized clinical trial of 131 women veterans with PTSD who use US Department of Veterans Affairs health care, TCTSY had large within-group effect sizes, equivalent effectiveness to CPT, and a 42.6% higher treatment completion rate than CPT. The findings demonstrate that TCTSY is a cost-effective means to expand Veterans Affairs PTSD treatment options; increase access to acceptable, patient-driven, and effective PTSD treatment for women veterans; and provide a treatment option that could improve associated symptoms (eg, depression, anxiety). This randomized clinical trial evaluated the effectiveness of trauma-sensitive yoga vs cognitive processing therapy for women veterans with military sexual trauma–related posttraumatic stress disorder (PTSD). First-line treatment for posttraumatic stress disorder (PTSD) in the US Department of Veterans Affairs (VA), ie, trauma-focused therapy, while effective, is limited by low treatment initiation, high dropout, and high treatment refraction. To evaluate the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) vs first-line cognitive processing therapy (CPT) in women veterans with PTSD related to military sexual trauma (MST) and the hypothesis that PTSD outcomes would differ between the interventions. This multisite randomized clinical trial was conducted from December 1, 2015, to April 30, 2022, within 2 VA health care systems located in the southeast and northwest. Women veterans aged 22 to 71 years with MST-related PTSD were enrolled and randomized to TCTSY or CPT. The TCTSY intervention (Hatha-style yoga focusing on interoception and empowerment) consisted of 10 weekly, 60-minute group sessions, and the CPT intervention (cognitive-based therapy targeting modification of negative posttraumatic thoughts) consisted of 12 weekly, 90-minute group sessions. Sociodemographic data were collected via self-report survey. The primary outcome, PTSD symptom severity, was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5). Assessments were conducted at baseline, midintervention, 2 weeks post intervention, and 3 months post intervention. Of 200 women veterans who consented to participate, the intent-to-treat sample comprised 131 participants (mean [SD] age, 48.2 [11.2] years), with 72 randomized to TCTSY and 59 randomized to CPT. Treatment was completed by 47 participants (65.3%) in the TCTSY group and 27 (45.8%) in the CPT group, a 42.6% higher treatment completion rate in the TCTSY group (P = .03). Both treatment groups improved over time on the CAPS-5 (mean [SD] scores at baseline: 36.73 [8.79] for TCTSY and 35.52 [7.49] for CPT; mean [SD] scores at 3 months: 24.03 [11.55] for TCTSY and 22.15 [13.56]) and the PCL-5 (mean [SD] scores at baseline: 49.62 [12.19] for TCTSY and 48.69 [13.62] for CPT; mean [SD] scores at 3 months: 36.97 [17.74] for TCTSY and 31.76 [12.47]) (P < .001 for time effects). None of the group effects or group-by-time effects were significant. Equivalence analyses of change scores were not significantly different between the TCTSY and CPT groups, and the two one-sided test intervals fell within the equivalence bounds of plus or minus 10 for CAPS-5 for all follow-up time points. In this comparative effectiveness randomized clinical trial, TCTSY was equivalent to CPT in reducing PTSD symptom severity, with both groups improving significantly. The higher treatment completion rate for TCTSY indicates its higher acceptability as an effective and acceptable PTSD treatment for women veterans with PTSD related to MST that could address current VA PTSD treatment limitations. ClinicalTrials.gov Identifier: NCT02640690
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