Prevention of Recurrence in Depression with Drugs and Cognitive Therapy

描述（由申请人提供）：人们普遍认为，抗抑郁药物（ADM）和心理治疗联合治疗抑郁症比单独治疗更有效。有证据表明，添加认知治疗（CT）可以增强ADM的初始效果，但大多数相关研究都受到低功率的影响。大量研究的结果也表明，CT具有持久的效果，但大多数证据都与预防复发有关-与治疗发作相关的症状的复发。关于更关键的预防问题：先前的CT暴露是否可以预防复发-新发作的发生，几乎没有证据。我们需要的是一项足够有力的研究，以发现在ADM中加入CT可能带来的好处，并能解决随之而来的成本效益问题。在过去的几年里，我们随机选择了450名抑郁症门诊患者（三个地点各150人）单独进行ADM或ADM加CT。所有患者均接受治疗至缓解，然后恢复（每个阶段允许长达18个月），根据临床指示，使用多达四种不同类型的抗抑郁药物加上增强治疗。随机抽取一半的患者在接受药物治疗的同时接受CT检查。然后将康复的患者随机分配到维持药物组或停药组；合并的患者从正在进行的CT中退出。然后对患者进行为期三年的随访，以检测复发情况。主要假设是：(1)联合治疗的缓解率和恢复率高于单独治疗；(2)事先接受CT检查可以防止停药后复发。至此，摄入已经完成，450名患者被随机分配到治疗组。估计的缓解率（占所有指定患者的75%）和恢复率（达到缓解的患者的83%）一直很强劲，迄今已有150多名康复患者进入维持阶段。该试验的完成将允许对缓解、恢复和复发方面的治疗效果进行强有力的测试，以及探索潜在机制（调解）和通过治疗相互作用（调节）描述患者类型，可用于完善治疗指南。

DESCRIPTION (provided by applicant): It is commonly believed that the combination of antidepressant medications (ADM) and psychotherapy is more efficacious in the treatment of depression than either treatment alone. There is evidence that adding cognitive therapy (CT) enhances the initial effects of ADM, but most of the relevant studies have suffered from low power. Findings from numerous studies also suggest that CT has an enduring effect, but most of the evidence has been relevant to the prevention of relapse - the return of symptoms associated with the treated episode. There is little evidence on the more critical prevention question: whether prior exposure to CT prevents recurrence - the onset of new episodes. What is needed is a study with power sufficient to detect the benefits that might accompany the addition of CT to ADM, and that can address the attendant cost-effectiveness questions. Over the last few years we have randomized 450 depressed outpatients (150 at each of three sites) to ADM alone or to ADM plus CT. All patients are treated to remission and then to recovery (allowing up to 18 months in each phase) with up to four different classes of antidepressant medications plus augmentation, as clinically indicated. A random half of the patients receive CT in addition to medications. Recovered patients are then assigned randomly to either maintenance medications or medication withdrawal; patients in the combined condition are withdrawn from ongoing CT. Patients are then followed for a three-year period for the purpose of detecting recurrences. The main hypotheses are that: (1) rates of remission and recovery will be higher in the combined treatment relative to ADM alone; and (2) prior exposure to CT will protect against recurrence following medication withdrawal. At this point, intake is complete, and 450 patients have been randomized to treatment. Estimated rates of remission (75% of all assigned) and recovery (83% of those who reach remission) have been strong, and over 150 recovered patients have entered the maintenance phase to date. Completion of this trial will allow for powerful tests of treatment effects with respect to remission, recovery, and recurrence, as well as the exploration of underlying mechanisms (mediation) and the delineation of patient-type by treatment interactions (moderation) that can be used to refine treatment guidelines.