Abstract：
BACKGROUND: Patients with bipolar disorder (BD) are frequently exposed to traumatic events which worsen disease course, but this study is the first multicentre randomised controlled trial to test the efficacy of a trauma-focused adjunctive psychotherapy in reducing BD affective relapse rates.
METHODS: This multicentre randomised controlled trial included 77 patients with BD and current trauma-related symptoms. Participants were randomised to either 20 sessions of trauma-focused Eye Movement Desensitization and Reprocessing (EMDR) therapy for BD, or 20 sessions of supportive therapy (ST). The primary outcome was relapse rates over 24-months, and secondary outcomes were improvements in affective and trauma symptoms, general functioning, and cognitive impairment, assessed at baseline, post-treatment, and at 12- and 24-month follow-up. The trial was registered prior to starting enrolment in clinical trials (NCT02634372) and carried out in accordance with CONSORT guidelines.
RESULTS: There was no significant difference between treatment conditions in terms of relapse rates either with or without hospitalisation. EMDR was significantly superior to ST at the 12-month follow up in terms of reducing depressive symptoms (p=0.0006, d=0.969), manic symptoms (p=0.027, d=0.513), and improving functioning (p=0.038, d=0.486). There was no significant difference in dropout between treatment arms.
CONCLUSIONS: Although the primary efficacy criterion was not met in the current study, trauma-focused EMDR was superior to ST in reducing of affective symptoms and improvement of functioning, with benefits maintained at six months following the end of treatment. Both EMDR and ST reduced trauma symptoms as compared to baseline, possibly due to a shared benefit of psychotherapy. Importantly, focusing on traumatic events did not increase relapses or dropouts, suggesting psychological trauma can safely be addressed in a BD population using this protocol.
METHODS: This multicentre randomised controlled trial included 77 patients with BD and current trauma-related symptoms. Participants were randomised to either 20 sessions of trauma-focused Eye Movement Desensitization and Reprocessing (EMDR) therapy for BD, or 20 sessions of supportive therapy (ST). The primary outcome was relapse rates over 24-months, and secondary outcomes were improvements in affective and trauma symptoms, general functioning, and cognitive impairment, assessed at baseline, post-treatment, and at 12- and 24-month follow-up. The trial was registered prior to starting enrolment in clinical trials (NCT02634372) and carried out in accordance with CONSORT guidelines.
RESULTS: There was no significant difference between treatment conditions in terms of relapse rates either with or without hospitalisation. EMDR was significantly superior to ST at the 12-month follow up in terms of reducing depressive symptoms (p=0.0006, d=0.969), manic symptoms (p=0.027, d=0.513), and improving functioning (p=0.038, d=0.486). There was no significant difference in dropout between treatment arms.
CONCLUSIONS: Although the primary efficacy criterion was not met in the current study, trauma-focused EMDR was superior to ST in reducing of affective symptoms and improvement of functioning, with benefits maintained at six months following the end of treatment. Both EMDR and ST reduced trauma symptoms as compared to baseline, possibly due to a shared benefit of psychotherapy. Importantly, focusing on traumatic events did not increase relapses or dropouts, suggesting psychological trauma can safely be addressed in a BD population using this protocol.
摘要：
背景：双相情感障碍（BD）患者经常遭受创伤事件，这会使病程恶化，但这项研究是首个多中心随机对照试验,旨在检验创伤聚焦辅助心理治疗在降低BD情感复发率方面的疗效.
方法：这项多中心随机对照试验纳入了77名患有BD和当前创伤相关症状的患者。参与者被随机分为20次针对BD的创伤聚焦眼动脱敏和再处理（EMDR）治疗，或20次支持治疗（ST）。主要结果是24个月以上的复发率，次要结果是情感和创伤症状的改善，一般功能，和认知障碍，在基线评估，治疗后,在12个月和24个月的随访中。该试验在开始纳入临床试验（NCT02634372）之前注册，并按照CONSORT指南进行。
结果：无论是否住院治疗，治疗条件在复发率方面均无显著差异。在12个月的随访中，EMDR在减轻抑郁症状方面明显优于ST（p=0.0006，d=0.969），躁狂症状（p=0.027，d=0.513），改善功能(p=0.038，d=0.486)。治疗组之间的退出没有显着差异。
结论：尽管本研究未达到主要疗效标准，创伤聚焦EMDR在减少情感症状和改善功能方面优于ST，在治疗结束后的6个月内保持获益。与基线相比，EMDR和ST均减轻了创伤症状，可能是因为心理治疗的共同利益.重要的是,专注于创伤事件并没有增加复发或辍学，表明心理创伤可以安全地解决BD人群中使用该方案。
方法：这项多中心随机对照试验纳入了77名患有BD和当前创伤相关症状的患者。参与者被随机分为20次针对BD的创伤聚焦眼动脱敏和再处理（EMDR）治疗，或20次支持治疗（ST）。主要结果是24个月以上的复发率，次要结果是情感和创伤症状的改善，一般功能，和认知障碍，在基线评估，治疗后,在12个月和24个月的随访中。该试验在开始纳入临床试验（NCT02634372）之前注册，并按照CONSORT指南进行。
结果：无论是否住院治疗，治疗条件在复发率方面均无显著差异。在12个月的随访中，EMDR在减轻抑郁症状方面明显优于ST（p=0.0006，d=0.969），躁狂症状（p=0.027，d=0.513），改善功能(p=0.038，d=0.486)。治疗组之间的退出没有显着差异。
结论：尽管本研究未达到主要疗效标准，创伤聚焦EMDR在减少情感症状和改善功能方面优于ST，在治疗结束后的6个月内保持获益。与基线相比，EMDR和ST均减轻了创伤症状，可能是因为心理治疗的共同利益.重要的是,专注于创伤事件并没有增加复发或辍学，表明心理创伤可以安全地解决BD人群中使用该方案。
