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非创伤聚焦冥想与暴露疗法治疗创伤后应激障碍退伍军人的随机对照试验

Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.

作者信息

Nidich Sanford, Mills Paul J, Rainforth Maxwell, Heppner Pia, Schneider Robert H, Rosenthal Norman E, Salerno John, Gaylord-King Carolyn, Rutledge Thomas

机构信息

Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA.

VA San Diego Healthcare System, San Diego, CA, USA; Department of Family Medicine and Public Health, and Department of Psychiatry, University of California, San Diego, CA, USA.

出版信息

Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.

Abstract

BACKGROUND

Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE).

METHODS

We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123.

FINDINGS

Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score.

INTERPRETATION

A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD.

FUNDING

Department of Defense, US Army Medical Research.

摘要

背景

创伤后应激障碍(PTSD)是一种复杂且难以治疗的疾病,影响着10%至20%的退伍军人。先前的研究提出了一个问题,即非创伤聚焦治疗是否能像创伤暴露疗法一样有效地减轻PTSD症状。本研究旨在通过一项非劣效性临床试验,比较超觉静坐(TM)这种非创伤聚焦疗法与延长暴露疗法(PE),并将这两种疗法与PTSD健康教育(HE)对照进行比较。

方法

我们在美国加利福尼亚州圣地亚哥退伍军人事务部医疗保健系统进行了一项随机对照试验。我们纳入了203名现役军人导致的PTSD患者,采用分层区组随机化方法将其随机分配到TM组、PE组或HE积极对照组。每种治疗在12周内提供12次疗程,并要求每日在家练习。TM和HE主要以小组形式进行,PE则单独进行。主要结局是3个月内PTSD症状严重程度的变化,通过临床医生管理的PTSD量表(CAPS)进行评估。分析采用意向性分析。我们假设在改善CAPS评分方面(Δ=10),TM不会劣于PE,且TM和PE优于PTSD健康教育。本研究已在ClinicalTrials.gov注册,注册号为NCT01865123。

结果

在2013年6月10日至2016年10月7日期间,203名退伍军人被随机分配到干预组(68人至TM组,68人至PE组,67人至PTSD HE组)。从基线到测试后3个月,TM在CAPS评分变化方面显著不劣于PE(两组平均变化差异为-5·9,95%CI为-14·3至2·4,p=0·0002)。在标准优效性比较中,发现TM与PTSD HE相比CAPS评分显著降低(-14·6,95%CI为-23·3至-5·9,p=0·0009),PE与PTSD HE相比也显著降低(-8·7,95%CI为-17·0至-0·32,p=0·041)。接受TM治疗的患者中有61%、接受PE治疗的患者中有42%、接受HE治疗的患者中有32%在CAPS评分上显示出临床显著改善。

解读

一种非创伤聚焦疗法TM可能是减轻退伍军人PTSD症状严重程度的可行选择,对于那些不愿接受或对传统PTSD暴露疗法无反应的退伍军人来说,是一种有效的替代方法。

资助

美国国防部、美国陆军医学研究部

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