Prevention of Recurrence in Depression with Drugs and Cognitive Therapy

通过药物和认知疗法预防抑郁症复发

• 批准号: 7392335
• 负责人: STEVEN DENNIS HOLLON
• 金额: $ 46.96万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-16 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7392335
• 关键词: Acute; Address; Antidepressive Agents; Characteristics; Class; Cognitive; Cognitive Therapy; Combined Modality Therapy; Condition; Depressed mood; Disease remission; Exposure to; Guidelines; Intake; Maintenance; Mediating; Mediation; Mental Depression; Outcome; Outpatients; Patients; Personality Disorders; Pharmaceutical Preparations; Phase; Prevention; Probability; Psychotherapy; Purpose; Randomized; Rate; Recovery; Recurrence; Relapse; Relative (related person); Risk; Sampling; Site; Symptoms; Testing; Withdrawal; chronic depression; comparative; cost; cost effectiveness; disorder later incidence prevention; follow-up; indexing; interest; pill; prevent; skills; treatment effect

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assigned randomly to either maintenance medications or medication withdrawal; patients in the combined condition are withdrawn from ongoing CT.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.

描述（由申请人提供）：通常认为，抗抑郁药（ADM）和心理治疗的组合在治疗抑郁症方面比单独治疗更有效。有证据表明，添加认知疗法（CT）增强了ADM的初始影响，但是大多数相关研究都遭受了低功率。来自众多研究的发现还表明，CT具有持久的作用，但是大多数证据与预防复发有关 - 与治疗发作相关的症状恢复。关于更关键的预防问题，几乎没有证据：事先接触CT是否阻止了复发 - 新情节的发作。需要的是一项具有足够能力的研究，足以检测到CT增加ADM的收益，并且可以解决随之而来的成本效益问题。在过去的几年中，我们将450个抑郁门诊病人（在三个地点的每个地点）随机分配给ADM或ADM加上CT。如临床上所示，所有患者均被治疗以缓解缓解，然后恢复（在每个阶段最多允许18个月），最多四种不同类别的抗抑郁药和增强。除了药物外，一半的患者还接受了CT。然后将恢复的患者随机分配给维持药物或戒断药物；从持续的CT中撤出了处于合并状况的患者。然后随后遵循三年的患者，以检测复发。主要的假设是：（1）相对于单独的ADM，合并治疗的缓解率和恢复率将更高； （2）事先接触CT将防止药物戒断后的复发。在这一点上，摄入量已经完成，有450名患者被随机进行治疗。估计的缓解率（占所有分配的75％）和恢复率（其中83％达到缓解的人）很强，迄今为止，已有150多名追回的患者进入了维护阶段。该试验的完成将允许在缓解，恢复和复发方面对治疗效应进行强有力的测试，以及可通过治疗相互作用（适度）来探索潜在机制（调解）和划定患者型的，可用于完善治疗指南。