Background: Continuation or maintenance electroconvulsive therapy (C/M-ECT) is recommended to reduce relapse rates of patients with major depressive disorder. During the ongoing COVID-19 pandemic, ECT services have come under pressure or needed to close because of redirected resources and safety reasons. We investigated the impact of C/M-ECT discontinuation on relapse in patients with unipolar depressive disorder in Flanders, Belgium.Methods: Between March 30 and June 18, 2020, all patients receiving C/M-ECT in 2 ECT centers were included. Continuation or maintenance electroconvulsive therapy was discontinued in 33 patients and continued in 4 patients. Relapse was defined as the need to restart ECT or the need for hospitalization. Depressive symptoms were assessed every 3 weeks using the Patient Health Questionnaire, the Clinical Global Impression Scale, and 2 additional patient-rated questions.Results: Relapse in the discontinuation group was 60.6%. All 4 patients who continued ECT remained remitted. Kaplan-Meier survival analysis showed significantly shorter relapse rates for patients receiving bitemporal and/or frequent C/M-ECT (1-to 2-week intervals). Patients older than 60 years showed longer survival rates.
Conclusions:Our results confirm earlier prospective and retrospective data regarding the efficacy and importance of C/M-ECT as relapse prevention. After treatment discontinuation, close monitoring of early warning signs for relapse is crucial, especially in the first few months. With the COVID-19 pandemic continuing, our data provide an indication of the necessity to ensure adequate care and access to ECT not only for the acutely ill but also for the vulnerable patients who are depending on C/M-ECT.
Background
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).
Method/design
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.
Discussion
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.
Trial registration
The study is registered with ClinicalTrials.gov. Study ID: NCT04383509
Trial registration date: 12.05.2020.
immunization program. When published (61% of countries), rationale for inclusion into immunization program is not always available (76% of cases). Evidence requirements from National Immunization Technical Advisory Groups (NITAGs) and Health Technology Assessment (HTA) Agencies, when involved in the process (12 EU countries) are often not clear and interactions seem limited. As a result, estimated median time to patient access for exemplary vaccines from marketing authorization vary from 2 to .6 years. Discussion: Given their preventative nature and long-term benefits, the value of vaccination is complex to assess. A robust framework for early consultation that allows earlier engagement with payers coupled with more documented and publicly transparent decision making at national level, may reduce time to access for EU citizens. In most of EU countries there is uncertainty among roles and responsibilities of involved parties. Better coordination and opposable timelines between stakeholders that can increase the understanding of evidence requirements and process may reduce delays in access. Conclusions: Varying length in time to access for vaccines across EU28 indicates there is scope for improvement to allow better predictability. At EU level, appropriate EC policy and support is needed to reduce time to access for citizens. At a national level, secured financing of vaccination program and greater collaboration and coordination between stakeholders to drive more transparent assessment guidelines for vaccines provide opportunity for faster patient access to vaccines.
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