Supplementary Material for: A Randomized Clinical Trial of Cognitive-Behavioral Therapy for Insomnia to Augment Posttraumatic Stress Disorder Treatment in Survivors of Interpersonal Violence

<b><i>Introduction:</i></b> Individuals exposed to interpersonal violence (IPV) commonly develop posttraumatic stress disorder (PTSD) with co-occurring depression and insomnia. Standard PTSD interventions such as cognitive processing therapy (CPT) do not typically lead to remission or improved insomnia. Cognitive behavioral therapy for insomnia (CBTi) improves insomnia in individuals with PTSD, but PTSD severity remains elevated. <b><i>Objective:</i></b> To determine whether sequential treatment of insomnia and PTSD is superior to treatment of only PTSD. <b><i>Methods:</i></b> In a 20-week trial, 110 participants exposed to IPV who had PTSD, depression and insomnia were randomized to CBTi followed by CPT or to attention control followed by CPT. Primary outcomes following CBTi (or control) were the 6-week change in score on the Insomnia Severity Index (ISI), the Clinician-Administered PTSD Scale (CAPS), and the Hamilton Rating Scale for Depression (HAM-D). Primary outcomes following CPT were the 20-week change in scores. <b><i>Results:</i></b> At 6 weeks, the CBTi condition had greater reductions in ISI, HAM-D, and CAPS scores than the attention control condition. At 20 weeks, participants in the CBTi+CPT condition had greater reductions in ISI, HAM-D, and CAPS scores compared to control+CPT. Effects were larger for insomnia and for depression than for PTSD. Similar patterns were observed with respect to clinical response and remission. A tipping point sensitivity analyses supported the plausibility of the findings. <b><i>Conclusions:</i></b> The sequential delivery of CBTi and CPT had plausible, significant effects on insomnia, depression, and PTSD compared to CPT alone. The effects for PTSD symptoms were moderate and clinically meaningful.

引言：遭受人际暴力（interpersonal violence, IPV）的个体通常会罹患创伤后应激障碍（posttraumatic stress disorder, PTSD），并共病抑郁与失眠症状。针对PTSD的标准干预手段如认知加工疗法（cognitive processing therapy, CPT）通常无法实现症状缓解或改善失眠状况。失眠认知行为疗法（cognitive behavioral therapy for insomnia, CBTi）可改善PTSD患者的失眠症状，但PTSD的严重程度仍居高不下。研究目的：探究先针对失眠、再针对PTSD的序贯治疗方案是否优于单纯针对PTSD的治疗方案。研究方法：本研究为一项为期20周的临床试验，共纳入110名遭受人际暴力且同时罹患PTSD、抑郁与失眠的参与者，将其随机分配至两个实验组：先接受CBTi再接受CPT组，以及先接受注意对照干预再接受CPT组。CBTi（或对照干预）阶段后的主要结局指标为：失眠严重指数量表（Insomnia Severity Index, ISI）、临床医师评定PTSD量表（Clinician-Administered PTSD Scale, CAPS）以及汉密尔顿抑郁量表（Hamilton Rating Scale for Depression, HAM-D）的6周得分变化量。CPT阶段后的主要结局指标为20周内的得分变化量。研究结果：干预6周时，CBTi组的ISI、HAM-D及CAPS得分降幅均显著大于注意对照组。干预20周时，CBTi联合CPT组参与者的ISI、HAM-D及CAPS得分降幅均显著优于对照联合CPT组。相较于PTSD症状，该方案对失眠与抑郁症状的改善效应更为显著。临床应答与症状缓解方面也观察到了相似的结果模式。临界点敏感性分析证实了本研究结果的合理性与可靠性。研究结论：相较于单纯CPT治疗，CBTi与CPT的序贯治疗方案对失眠、抑郁及PTSD症状均具有显著且可靠的改善效应。该方案对PTSD症状的改善程度为中度，且具有临床意义。