【概要】背景：许多患者目前无法获得创伤后应激障碍（PTSD）的心理治疗，并且尚不清楚哪种类型的治疗师辅助的基于互联网的治疗效果最好。我们的目的是调查是否有一种新型的互联网提供的针对PTSD的认知疗法 (iCT-PTSD)，该疗法实施了英国国家健康与护理卓越研究所 (NICE) 推荐的针对PTSD的一线、以创伤为重点的干预措施的所有程序，优于互联网提供的针对PTSD的压力管理疗法 (iStress-PTSD)。这是一种专注于广泛应对技能的综合认知行为治疗计划。方法：我们在英国的三个地点进行了一项单盲、随机对照试验。参与者（≥18岁）是从英国国家医疗服务体系 (NHS) 改善获得心理治疗 (IAPT) 服务或通过自我推荐招募的，并且符合DSM-5针对单一或多个事件的PTSD标准。参与者通过计算机程序 (3:3:1) 被随机分配到iCT-PTSD、iStress-PTSD或接受常规NHS护理的3个月等候名单，之后仍符合PTSD标准的患者被随机分配（1: 1) iCT-PTSD或iStress-PTSD。随机分组按地点、PTSD持续时间（<18个月或≥18个月）以及PTSD症状的严重程度（高与低）进行分层。iCT-PTSD和iStress-PTSD是在治疗师的支持下在线提供的，在前12周（每周治疗阶段）内通过消息和每周简短的电话进行支持，并在接下来的3个月内进行3次电话（加强阶段）。主要结局是随机分配后13周时PTSD症状的严重程度，通过DSM-5 (PCL-5) PTSD检查表上的自我报告进行测量，并通过意向治疗进行分析。对所有开始治疗的参与者进行安全性评估。过程分析调查了治疗的可接受性和依从性，以及结果的候选调节器和调节器。该试验已在ISRCTN登记处前瞻性注册，ISRCTN16806208。发现：在217名参与者中，158名（73%）自称是女性，57名（26%）是男性，还有2名（1%）是其他人；170名 (78%) 为英国白人，20名 (9%) 为其他白人，六名(3%) 为亚洲人，十名 (5%) 为黑人，八名 (4%) 为混合种族背景，三名 (1%) ）有其他种族背景。平均年龄为36.36岁（SD12.11；范围18-71岁）。52名 (24%) 参与者符合ICD-11复杂PTSD的自我报告标准。每个治疗组中退出的参与者均少于10%。iCT-PTSD在减少PTSD症状方面优于iStress-PTSD，PCL-5的调整后差异为–4.92（95% CI –8.92 至 –0.92；p=0.016；标准化效果尺度 d=0.38 [0.07至0.69]) 用于立即分配，以及–5.82（–9.59至–2.04；p=0.0027；d=0.44 [0.15到0.72]) 对于所有治疗分配。两种治疗均优于13周时PCL-5创伤后应激障碍的等待名单（iCT-PTSD的d=1.67 [1.23至2.10]，iStress的d=1.29 [0.85至1.72]））。对于具有高度分离或复杂PTSD症状的参与者来说，iCT-PTSD的结果优势更大，中介分析显示，这两种治疗方法都是通过改变创伤的负面含义、无益的应对和闪回记忆来发挥作用。没有报告严重不良事件。解释：以创伤为中心的iCT-PTSD对PTSD患者来说是有效且可接受的，并且优于以创伤为中心的认知行为压力管理疗法，这表明iCT-PTSD是传递CT-PTSD内容的有效方式，其中之一NICE推荐的PTSD一线治疗方法，同时与面对面治疗相比减少了治疗师的时间。

[Summary] Background: Many patients are currently unable to access psychological treatments for post-traumatic stress disorder (PTSD), and it is unclear which types of therapist-assisted internet-based treatments work best. We aimed to investigate whether a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a first-line, trauma-focused intervention recommended by the UK National Institute for Health and Care Excellence (NICE) for PTSD, is superior to internet-delivered stress management therapy for PTSD (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. Methods: We did a single-blind, randomised controlled trial in three locations in the UK. Participants (≥18 years) were recruited from UK National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services or by self-referral and met DSM-5 criteria for PTSD to single or multiple events. Participants were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD, or a 3-month waiting list with usual NHS care, after which patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. Randomisation was stratified by location, duration of PTSD (<18 months or ≥18 months), and severity of PTSD symptoms (high vs low). iCT-PTSD and iStress-PTSD were delivered online with therapist support by messages and short weekly phone calls over the first 12 weeks (weekly treatment phase), and three phone calls over the next 3 months (booster phase). The primary outcome was the severity of PTSD symptoms at 13 weeks after random assignment, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5), and analysed by intention-to-treat. Safety was assessed in all participants who started treatment. Process analyses investigated acceptability and compliance with treatment, and candidate moderators and mediators of outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN16806208. Findings: Of the 217 participants, 158 (73%) self-reported as female, 57 (26%) as male, and two (1%) as other; 170 (78%) were White British, 20 (9%) were other White, six (3%) were Asian, ten (5%) were Black, eight (4%) had a mixed ethnic background, and three (1%) had other ethnic backgrounds. Mean age was 36.36 years (SD 12.11; range 18–71 years). 52 (24%) participants met self-reported criteria for ICD-11 complex PTSD. Fewer than 10% of participants dropped out of each treatment group. iCT-PTSD was superior to iStress-PTSD in reducing PTSD symptoms, showing an adjusted difference on the PCL-5 of –4.92 (95% CI –8.92 to –0.92; p=0.016; standardised effect size d=0.38 [0.07 to 0.69]) for immediate allocations and –5.82 (–9.59 to –2.04; p=0.0027; d=0.44 [0.15 to 0.72]) for all treatment allocations. Both treatments were superior to the waiting list for PCL-5 at 13 weeks (d=1.67 [1.23 to 2.10] for iCT-PTSD and 1.29 [0.85 to 1.72] for iStress-PTSD). The advantages in outcome for iCT-PTSD were greater for participants with high dissociation or complex PTSD symptoms, and mediation analyses showed both treatments worked by changing negative meanings of the trauma, unhelpful coping, and flashback memories. No serious adverse events were reported. Interpretation: Trauma-focused iCT-PTSD is effective and acceptable to patients with PTSD, and superior to a non-trauma-focused cognitive behavioural stress management therapy, suggesting that iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while reducing therapist time compared with face-to-face therapy.

论文原文：Anke Ehlers, Jennifer Wild, Emma Warnock-Parkes, Nick Grey, Hannah Murray, Alice Kerr, et al. (2023). Therapist-assisted online psychological therapies differing in trauma focus for post-traumatic stress disorder (STOP-PTSD): a UK-based, single-blind, randomised controlled trial. The Lancet - Psychiatry, 10 (8): 608-622.

https://doi.org/10.1016/S2215-0366(23)00181-5

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