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: 7568170
• 负责人: STEVEN DENNIS HOLLON
• 金额: $ 38.52万
• 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/7568170
• 关键词: Acute; Address; Antidepressive Agents; Characteristics; Cognitive; Cognitive Therapy; Combined Modality Therapy; Disease remission; Exposure to; Guidelines; Intake; Maintenance; Mediating; Mediation; Outcome; Outpatients; Patients; Personality Disorders; Pharmaceutical Preparations; Phase; Prevention; Probability; Psychotherapy; Randomized; Recovery; Recurrence; Relapse; Relative (related person); Risk; Sampling; Site; Symptoms; Testing; Withdrawal; chronic depression; comparative; cost; cost effectiveness; depressed; depression; 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assigned randomly to either maintenance medications or medication withdrawal; patients in the combined condition are withdrawn from ongoing CT.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）：人们普遍认为，抗抑郁药物（ADM）和心理治疗的组合在治疗抑郁症方面比单独使用任何一种治疗更有效。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存在功效较低的问题。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（与治疗的发作相关的症状复发）有关。对于更关键的预防问题，几乎没有证据表明：之前接受 CT 扫描是否可以预防复发（新发作的发生）。我们需要的是一项有足够能力的研究，以发现在 ADM 中添加 CT 可能带来的好处，并且可以解决随之而来的成本效益问题。在过去几年中，我们将 450 名抑郁症门诊患者（三个中心各 150 名）随机分配至单独 ADM 组或 ADM 加 CT 组。所有患者均接受最多四种不同类别的抗抑郁药物加增强治疗（根据临床指示）直至缓解，然后恢复（每个阶段最多 18 个月）。随机一半的患者除了药物治疗外还接受 CT 检查。然后，康复的患者被随机分配接受维持药物治疗或停药治疗；患有合并病症的患者退出正在进行的 CT。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）联合治疗相对于单独使用ADM，缓解率和恢复率更高； (2) 预先接受 CT 检测可防止停药后复发。至此，收治完毕，450 名患者已被随机分配接受治疗。预计缓解率（占所有分配患者的 75%）和恢复率（达到缓解者的 83%）很高，迄今为止已有超过 150 名康复患者进入维持阶段。该试验的完成将能够对缓解、恢复和复发方面的治疗效果进行强有力的测试，并探索潜在的机制（中介）和通过可使用的治疗相互作用（调节）来描述患者类型完善治疗指南。