INTRODUCTION Complex PTSD (CPTSD) is a relatively new condition in ICD-11. This pilot randomised controlled trial aimed to compare a four-module intervention developed to target all symptoms of ICD-11 CPTSD, namely Enhanced Skills in Affective and Interpersonal Regulation (ESTAIR) with treatment as usual (TAU). The purpose of the study was to assess feasibility, safety, acceptability, and preliminary outcomes at the end of treatment and 3-month follow-up. METHODS A total of N = 56 eligible veterans with CPTSD were randomised to either ESTAIR (n = 28) or TAU (n = 28). Linear mixed models were conducted to assess CPTSD severity, the primary outcome, as measured by the International Trauma Questionnaire (ITQ). RESULTS Treatment dropout in ESTAIR and TAU was low and equivalent (18% vs. 11%; χ2 (1) = 1.19, p = 0.275), and study retention was high, supporting the feasibility of the study. No serious adverse effects and very few adverse effects occurred, none of which were deemed related to the study. ESTAIR provided significantly greater reduction in CPTSD severity across time for ITQ PTSD (p < 0.001) and DSO (p < 0.001) symptoms. CPTSD pre-to-post effect sizes for ESTAIR were large (PTSD d = 1.78; DSO d = 2.00). Remission of probable CPTSD diagnosis at post-treatment was substantially greater in ESTAIR compared to TAU with only 13.6% versus 84% (p < 0.001) retaining the diagnosis. CONCLUSION A trial of ESTAIR versus TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.

中文翻译：

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ICD-11 复杂 PTSD 的情感和人际调节与常规治疗的强化技能培训：一项试点随机对照试验（RESTORE 试验）。


简介 复杂 PTSD (CPTSD) 是 ICD-11 中相对较新的病症。这项随机对照试验旨在比较针对 ICD-11 CPTSD 所有症状而开发的四模块干预措施，即情感和人际调节增强技能 (ESTAIR) 与照常治疗 (TAU)。该研究的目的是评估治疗结束和 3 个月随访时的可行性、安全性、可接受性和初步结果。方法 总共 N = 56 名符合条件的患有 CPTSD 的退伍军人被随机分配至 ESTAIR (n = 28) 或 TAU (n = 28)。采用线性混合模型来评估 CPTSD 严重程度，这是通过国际创伤问卷 (ITQ) 测量的主要结果。结果 ESTAIR 和 TAU 的治疗退出率较低且相当（18% vs. 11%；χ2 (1) = 1.19，p = 0.275），并且研究保留率较高，支持了该研究的可行性。没有发生严重的不良反应，也很少发生不良反应，这些不良反应均不被认为与本研究有关。 ESTAIR 显着降低了 ITQ PTSD (p < 0.001) 和 DSO (p < 0.001) 症状的 CPTSD 严重程度。 ESTAIR 的 CPTSD 前后效应值较大（PTSD d = 1.78；DSO d = 2.00）。与 TAU 相比，ESTAIR 治疗后可能的 CPTSD 诊断缓解率显着提高，保留诊断的比例分别为 13.6% 和 84% (p < 0.001)。结论 ESTAIR 与 TAU 治疗 ICD-11 CPTSD 的试验表明 ESTAIR 的潜在疗效及其可行性、安全性和可接受性。