Effects of a general practitioner-led brief narrative exposure intervention on symptoms of post-traumatic stress disorder after intensive care (PICTURE): multicentre, observer blind, randomised controlled trial.

Methods

Multicentre, observer blind, randomised controlled trial(PICTURE).

多中心、观察者盲法、随机对照试验（PICTURE）。

Primary care in 319 general practices across Germany.

在德国319个普通诊所进行的初级保健。

319 adults (18-85 years) who have survived critical illness with symptoms of PTSD, discharged from intensive care and randomised to receive the intervention (n=160) or improved usual care (n=159) from a general practitioner.

319名年龄在18至85岁之间的成年人，他们经历了危重病并表现出创伤后应激障碍（PTSD）的症状，从重症监护病房出院后被随机分配接受干预（n=160）或改进的常规护理（n=159），由全科医生提供。

Intervention group participants had three narrative exposure consultations with a general practitioner and eight scheduled contacts with a nurse.

干预组参与者与全科医生进行了三次叙述性暴露咨询，并与护士安排了八次接触。

Control group participants received improved treatment as usual based on the German PTSD guideline.

对照组参与者接受了基于德国PTSD指南的改进常规治疗。

The primary clinical outcome was self-reported PTSD symptoms using the Post-Traumatic Diagnostic Scale for DSM-5 (PDS-5, range 0-80, higher scores indicating more severe symptoms) at six months.

主要临床结果是使用创伤后应激障碍诊断量表 DSM-5 版（PDS-5，范围 0-80，分数越高表示症状越严重）在六个月时自我报告的 PTSD 症状。

The minimal clinically important difference was six points.

最小的临床重要差异是六分。

Secondary outcomes included changes in depression, anxiety, patient activation, health related quality of life and disability at six and 12 months.

次要结果包括在六个月和十二个月时抑郁、焦虑、患者激活、健康相关的生活质量和残疾的变化。

Results

Between 21 October 2018 and 18 January 2023, 1283 patients discharged from an intensive care unit were screened for PTSD symptoms. 319 study participants were randomly assigned either to the control group (n=159) or the intervention group (n=160).

在2018年10月21日至2023年1月18日期间，对1283名从重症监护病房出院的患者进行了创伤后应激障碍（PTSD）症状筛查。共有319名研究参与者被随机分配到对照组（n=159）或干预组（n=160）。

The mean patient age was 57.7 years (standard deviation (SD) 12.7), and 61% of participants were male.

患者的平均年龄为57.7岁（标准差（SD）12.7），61%的参与者为男性。

The mean baseline PDS-5 score was 30.6 (SD 13.3) in both groups. 271 (85%) study participants completed follow-up assessment after six months and 247 (77%) after 12 months.

两组患者的基线PDS-5评分为30.6（SD 13.3）。271名（85%）研究参与者在六个月后完成了随访评估，247名（77%）在12个月后完成了随访评估。

The intervention effect showed a mean between-group difference in the PDS-5 score of 4.7 points ((95% confidence interval1.6 to 7.8); P=0.003, Cohen's d=0.37)) at six months and 5.4 points ((1.8 to 9.0); P=0.003, Cohen's d=0.41)) at 12 months.

干预效果显示，六个月时PDS-5评分的组间平均差异为4.7分（95%置信区间1.6至7.8；P=0.003，Cohen's d=0.37），十二个月时为5.4分（95%置信区间1.8至9.0；P=0.003，Cohen's d=0.41）。

Among secondary outcomes, patients in the intervention group had greater improvements in depression, health related quality of life, and disability.

在次要结果中，干预组患者的抑郁、健康相关生活质量以及残疾状况的改善更为显著。

Conclusions

In adults with symptoms of PTSD after critical illness, a brief narrative exposure intervention was feasible and showed a reduction of symptoms, which was less than the predefined minimal clinically important difference.

在经历危重病后的成人 PTSD 症状患者中，简短的叙述性暴露干预是可行的，并显示出症状减轻，这低于预先设定的最小临床重要差异。

The effect was found to be sustained at 12 months' follow-up.

在12个月的随访中发现这种效果是持续的。

These findings support the further evaluation of this intervention in primary care.

这些发现支持在初级保健中进一步评估这一干预措施。

trial_registration

ClinicalTrials.gov, NCT03315390; DRKS-ID DRKS00012589.

ClinicalTrials.gov, NCT03315390; DRKS-ID DRKS00012589。