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. Trial registration [ISRCTN13697710][1]. The dataset is available from the corresponding author at bissonji@cardiff.ac.uk. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN13697710

中文翻译：

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基于互联网的指导性认知行为疗法治疗创伤后应激障碍：务实、多中心、随机对照非劣效性试验 (RAPID)


目的 确定针对一种创伤事件的轻至中度创伤后应激障碍 (PTSD)，基于互联网引导的创伤焦点认知行为疗法 (CBT-TF) 是否不劣于个体面对面 CBT-TF。设计务实、多中心、随机对照非劣效性试验 (RAPID)。在英国 NHS 中设置初级和二级心理健康设置。参与者包括 196 名初步诊断为轻度至中度 PTSD 的成年人，以 1:1 的比例随机接受两种干预措施之一，16 周时保留率为 82%，52 周时保留率为 71%。有目的地对 19 名参与者和 10 名治疗师进行了抽样和访谈，以评估该过程。干预 最多 12 次面对面、手动、单独的 CBT-TF 会话，每次持续 60-90 分钟；或基于互联网指导的 CBT-TF，包含八步在线计划，与治疗师进行长达三个小时的联系，并在治疗之间进行四次简短的电话或电子邮件联系。主要结果指标 主要结果是随机分组后 16 周时的临床医生管理的 DSM-5 PTSD 量表 (CAPS-5)（根据《精神疾病诊断和统计手册》第五版 DSM-5 的标准诊断 PTSD） 。次要结局包括 52 周时 PTSD 症状的严重程度，以及随机分组后 16 周和 52 周时的功能、抑郁和焦虑症状、饮酒以及感知的社会支持。结果 CAPS-5 在 16 周的主要终点上发现非劣效性（平均差 1.01，单侧 95% 置信区间 -∞ 至 3.90，非劣效性 P=0.012）。 两组的 CAPS-5 评分改善均在 52 周时维持在 60% 以上，但非劣效性结果尚无结论，有利于此时点的面对面 CBT-TF（3.20，-∞ 至6.00，P=0.15）。基于互联网引导的 CBT-TF 比面对面的 CBT-TF 便宜得多 (P<0.001)，并且参与者似乎可以接受和耐受。定性分析的主题是参与基于互联网引导的 CBT-TF 的促进因素和障碍、治疗结果以及未来实施的考虑因素。结论 基于互联网引导的 CBT-TF 治疗轻至中度 PTSD 至一次创伤事件并不逊色于个体面对面的 CBT-TF，应被视为患有这种情况的人的一线治疗。试用注册[ISRCTN13697710][1]。该数据集可从通讯作者 bissonji@cardiff.ac.uk 处获取。 [1]：/外部引用？link_type=ISRCTN&access_num=ISRCTN13697710