Bisson JI et al.BMJ. 2022 Jun 16;377:e069405. 

创伤后应激障碍(PTSD)是一种常见的精神健康状况，典型症状包括重新体验、回避和当前威胁感。如果不治疗，症状会持续多年与身心健康共病、经济负担密切相关，研究旨在确定以创伤为焦点的网络引导认知行为疗法(CBT-TF)对于轻度至中度创伤后应激障碍(PTSD)的疗效是否有效。

研究纳入196例患者，在CAPS-5试验的主要终点16周时发现非劣效性(平均差异1.01，单侧95%可信区间为3.90，非劣效性P=0.012)。在52周时，两组的CAPS5评分改善超过60%，但非劣效结果在此时点对面对面CBT-TF的支持不确定(3.20，至6.00,P=0.15)。基于引导的互联网CBT-TF明显(P＜0.001)比面对面的CBT-TF便宜，似乎被参与者接受和耐受良好。

研究结果证实，基于网络的指导CBT-TF治疗轻度至中度创伤后应激障碍至一次创伤事件的效果并不次于个体面对面CBT-TF，应被视为此类患者的一线治疗

Abstract

Objective: To determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event.

Design: Pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).

Setting: Primary and secondary mental health settings across the UK's NHS.

Participants: 196 adults with a primary diagnosis of mild to moderate PTSD were randomised in a 1:1 ratio to one of two interventions, with 82% retention at 16 weeks and 71% retention at 52 weeks. 19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process.

Interventions: Up to 12 face-to-face, manual based, individual CBT-TF sessions, each lasting 60-90 minutes; or guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions.

Main outcome measures: Primary outcome was the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation (diagnosis of PTSD based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5). Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation.

Results: Non-inferiority was found at the primary endpoint of 16 weeks on the CAPS-5 (mean difference 1.01, one sided 95% confidence interval -∞ to 3.90, non-inferiority P=0.012). Improvements in CAPS-5 score of more than 60% in the two groups were maintained at 52 weeks, but the non-inferiority results were inconclusive in favour of face-to-face CBT-TF at this time point (3.20, -∞ to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants. The main themes of the qualitative analysis were facilitators and barriers to engagement with guided internet based CBT-TF, treatment outcomes, and considerations for its future implementation.

Conclusions: Guided internet based CBT-TF for mild to moderate PTSD to one traumatic event was non-inferior to individual face-to-face CBT-TF and should be considered a first line treatment for people with this condition.

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