Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK
Centre for Trials Research, Cardiff University, Cardiff, UK.
BMJ. 2022 Jun 16;377:e069405. doi: 10.1136/bmj-2021-069405.
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.
Pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).
Primary and secondary mental health settings across the UK's NHS.
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.
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.
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 , 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.
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.
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.
ISRCTN13697710.
确定针对单一创伤事件的创伤聚焦认知行为疗法（CBT-TF）是否不劣于面对面的个体 CBT-TF，用于治疗轻度至中度创伤后应激障碍（PTSD）。
实用、多中心、随机对照非劣效性试验（RAPID）。
英国国民保健署的初级和二级精神卫生机构。
196 名患有轻度至中度 PTSD 的成年人以 1:1 的比例随机分配至两种干预措施之一，16 周时保留 82%，52 周时保留 71%。对 19 名参与者和 10 名治疗师进行了有针对性的抽样和访谈，以评估该过程。
最多 12 次面对面、基于手册的个体 CBT-TF 会议，每次持续 60-90 分钟；或基于互联网的创伤聚焦认知行为疗法，包括一个八步在线计划，最多与治疗师联系 3 小时，并在会议之间进行四次简短的电话或电子邮件联系。
主要结局指标是随机分组后 16 周时的 DSM-5 临床医生管理 PTSD 量表（CAPS-5）（基于 DSM-5 第五版标准诊断 PTSD）。次要结局指标包括 52 周时 PTSD 症状的严重程度，以及 16 周和 52 周时的功能、抑郁和焦虑症状、酒精使用情况以及感知社会支持。
在 CAPS-5 的主要终点（16 周）上发现了非劣效性（平均差异 1.01，单侧 95%置信区间-∞至 3.90，非劣效性 P=0.012）。两组的 CAPS-5 评分改善超过 60%在 52 周时得以维持，但此时非劣效性结果对面对面 CBT-TF 不确定（3.20，-∞至 6.00，P=0.15）。基于互联网的创伤聚焦认知行为疗法明显（P<0.001）比面对面的 CBT-TF 更便宜，并且似乎被参与者接受且耐受良好。定性分析的主要主题是参与基于互联网的创伤聚焦认知行为疗法的促进因素和障碍、治疗结果以及对其未来实施的考虑。
针对单一创伤事件的轻度至中度 PTSD 的基于互联网的创伤聚焦认知行为疗法不劣于面对面的个体 CBT-TF，应考虑作为该病症的一线治疗方法。
ISRCTN81425044。
