Supplementary Material for: Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) vs. Treatment as Usual (TAU) for ICD-11 Complex PTSD: A pilot randomised controlled trial (The RESTORE trial)

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 Treatment as Usual (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%; 2 (1) = 1.19, p = .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 < .001) and DSO (p < .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 < .001) retaining the diagnosis.
Conclusion
A trial of ESTAIR vs. TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.

引言
复杂性创伤后应激障碍（Complex PTSD, CPTSD）是《国际疾病分类第11版》（ICD-11）中相对新兴的病症。本先导性随机对照试验旨在对比针对ICD-11界定的全部CPTSD症状所开发的四模块干预方案——情感与人际调节增强技能（Enhanced Skills in Affective and Interpersonal Regulation, ESTAIR）与常规治疗（Treatment as Usual, TAU）的效果。本研究旨在评估该干预在治疗结束时及3个月随访中的可行性、安全性、可接受性及初步结局。

方法
共计56名符合入组标准的CPTSD退伍军人被随机分配至ESTAIR组（n=28）或常规治疗组（TAU, n=28）。采用线性混合模型对主要结局指标——CPTSD症状严重程度进行评估，该指标通过国际创伤问卷（International Trauma Questionnaire, ITQ）进行测评。

结果
ESTAIR组与TAU组的治疗脱落率均较低且组间无显著差异（18% vs. 11%；χ²(1)=1.19, p=0.275），研究保留率较高，证实了本研究的可行性。本研究未发生严重不良事件，不良事件发生率极低，且无一例被判定与研究相关。相较于TAU组，ESTAIR组随时间推移的CPTSD症状严重程度改善更为显著，体现在ITQ量表的PTSD维度（p<0.001）与DSO维度（p<0.001）。ESTAIR组的CPTSD症状前后效应量较大（PTSD维度d=1.78；DSO维度d=2.00）。治疗结束时，ESTAIR组的疑似CPTSD诊断缓解率显著高于TAU组：仅13.6%的ESTAIR组受试者仍符合诊断标准，而TAU组这一比例为84%（p<0.001）。

结论
针对ICD-11界定的CPTSD开展的ESTAIR对比常规治疗的临床试验结果显示，ESTAIR不仅具备可行性、安全性与可接受性，同时具有潜在的治疗有效性。