Major depressive episode (MDE) is worldwide one of the most prevalent and disabling mental health conditions. In cases of persistent non-response to treatment, electroconvulsive therapy (ECT) is a safe and effective treatment strategy with high response rates. Unfortunately, longitudinal data show low sustained response rates with 6-month relapse rates as high as 50% using existing relapse prevention strategies. Cognitive side effects of ECT, even though transient, might trigger mechanisms that increase relapse in patients who initially responded to ECT. Among these side effects, reduced cognitive control is an important neurobiological driven vulnerability factor for depression. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse). Eighty-eight patients aged between 18 and 70 years with MDE who start CCT will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), patients will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, we will monitor patients every 2 weeks for a period of 6 months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, we will assess patient evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance our understanding of the mechanisms underlying effects of CCT, exploratory analyses will be conducted using video footage collected during the CCT/active control phase of the study. Cognitive remediation will be performed following response to ECT, and an extensive follow-up period will be employed. Positive findings would not only benefit patients by decreasing relapse, but also by increasing acceptability of ECT, reducing the burden of cognitive side-effects. The study is registered with ClinicalTrials.gov . Study ID: NCT04383509 Trial registration date: 12.05.2020.

中文翻译：

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对患有抗药性抑郁症的患者进行电抽搐治疗后的认知补救措施：预防复发的干预措施的随机对照试验-研究方案。

重度抑郁发作（MDE）是全球范围内最普遍和最致残的心理健康状况之一。在持续对治疗无反应的情况下，电抽搐治疗（ECT）是一种安全有效的治疗策略，反应率高。不幸的是，纵向数据显示，使用现有的预防复发策略，6个月复发率低，持续缓解率高达50％。ECT的认知副作用，即使是短暂的，也可能触发机制，使最初对ECT产生反应的患者的复发率增加。在这些副作用中，降低的认知控制是抑郁症的重要的神经生物学驱动脆弱性因素。因此，认知控制训练（CCT）有望成为改善ECT长期疗效（即增加缓解，并减少抑郁症的复发）。开始进行CCT的年龄在18至70岁之间的MDE的88位患者将包括在该随机对照试验（RCT）中。在对ECT治疗产生（部分）响应（临床症状至少降低25％）之后，患者将被随机分配到基于计算机的CCT或有效的安慰剂对照中。该RCT的首要目的是评估与积极安慰剂相比，CCT对抑郁症症状，认知障碍和生活质量的影响。其次，在进行CCT /活性安慰剂治疗后的6个月内，我们将每2周监测一次患者，以检测潜在的抑郁症复发情况。第三，我们将使用定性访谈方法（满意度，可接受性和适当性）评估患者对ECT认知治疗的补充评价。最后，为了进一步提高我们对CCT的潜在作用机理的理解，将使用在研究的CCT /主动控制阶段收集的录像进行探索性分析。对ECT的反应后将进行认知矫正，并将采用广泛的随访期。阳性结果不仅会降低复发率，而且还会增加ECT的可接受性，减轻认知副作用的负担，从而使患者受益。该研究已在ClinicalTrials.gov上注册。研究编号：NCT04383509试用注册日期：2020年5月12日。对ECT的反应后将进行认知矫正，并将采用广泛的随访期。阳性结果不仅会降低复发率，而且还会增加ECT的可接受性，减轻认知副作用的负担，从而使患者受益。该研究已在ClinicalTrials.gov上注册。研究编号：NCT04383509试用注册日期：2020年5月12日。对ECT的反应后将进行认知矫正，并将采用广泛的随访期。阳性结果不仅会降低复发率，而且还会增加ECT的可接受性，减轻认知副作用的负担，从而使患者受益。该研究已在ClinicalTrials.gov上注册。研究编号：NCT04383509试用注册日期：2020年5月12日。