Are Cognitive Therapy's Antidepressant Effects Durable?

认知疗法的抗抑郁效果持久吗？

• 批准号: 6826813
• 负责人: ROBIN B JARRETT
• 金额: $ 35.1万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6826813
• 关键词: adult human (21+); antidepressants; behavioral /social science research tag; chemotherapy; clinical research; clinical trials; cognitive behavior therapy; depression; fluoxetine; human subject; human therapy evaluation; longitudinal human study; mental health epidemiology; patient oriented research; relapse /recurrence

DESCRIPTION (provided by applicant): We propose adding a 2 year follow-up to a funded, randomized clinical trial evaluating the efficacy of and indications for 8 months of continuation phase cognitive therapy (C-CT), pharmacotherapy (fluoxetine; FLX), and pill placebo (PBO) in outpatients with recurrent major depressive disorder (MDD) who are at higher risk for relapse. This initial project period will allow comment in the comparative durability of effects after the first year of follow-up after all protocol treatment is discontinued. In addition, we will begin to accrue data to evaluate the durability of effects over two years of follow-up. The trial and follow-up will be conducted by investigators at the University of Texas Southwestern Medical Center and the University of Pittsburgh School of Medicine. "Higher risk" is defined by incomplete remission during the final weeks of acute phase CT, while "lower risk" is defined as complete and stable remission (i.e., 7 consecutive Hamilton Rating Scale for Depression scores <7). This trial has great public health significance because it will help identify when CT reduces the risk of relapse and recurrence in patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can then be targeted for the most vigorous preventive treatment. This study is also the first to evaluate the continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. This contrast is important because many patients do not have adequate insurance coverage to support the full course of acute CT plus continuation phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. nonspecific therapeutic activity. The follow-up is important because it will allow comment not only on C-CT's preventive effect on relapse (while patients receive it) but also on recurrence (after it is discontinued). In this application, we propose to enter an additional 159 male and female outpatients, aged 18-70 with DSM-IV unipolar, nonpsychotic, recurrent MDD to 16 or 20 sessions of acute phase CT in order to have sufficient power to compare effects over the first year of follow-up. Additional responders at higher risk for relapse will be randomized to 8 months of: (a) C-CT, (b) FLX, or (c) PBO and then followed for 2 years; lower risk patients will be followed for 32 months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analysis are planned.

描述（由申请人提供）：我们建议在一项资助的随机临床试验中增加 2 年随访，该试验评估了对于复发风险较高的复发性重度抑郁症 (MDD) 门诊患者进行 8 个月的持续期认知治疗 (C-CT)、药物治疗（氟西汀；FLX）和安慰剂安慰剂 (PBO) 的疗效和适应症。这个初始项目期将允许在所有方案治疗停止后的第一年随访后对效果的相对持久性进行评论。此外，我们将开始收集数据来评估两年随访效果的持久性。试验和随访将由德克萨斯大学西南医学中心和匹兹堡大学医学院的研究人员进行。 “较高风险”的定义是急性期CT最后几周的不完全缓解，而“较低风险”的定义是完全稳定的缓解（即连续7次汉密尔顿抑郁量表评分<7）。这项试验具有重大的公共卫生意义，因为它将有助于确定 CT 何时能够降低复发性 MDD（一种发病率和死亡率较高的疾病）患者的复发风险。然后，可以针对复发风险最高的患者进行最有力的预防性治疗。这项研究也是第一个评估急性期 CT 不完全缓解后的持续期药物治疗 (FLX) 的研究。这种对比很重要，因为许多患者没有足够的保险来支持急性 CT 加持续期 CT 的整个疗程。此外，药物治疗组将允许测试模式特异性与非特异性治疗活性。随访很重要，因为它不仅可以评论 C-CT 对复发（患者接受治疗期间）的预防效果，还可以评论复发（停止治疗后）的效果。在本申请中，我们建议另外 159 名年龄 18-70 岁、患有 DSM-IV 单相、非精神病性、复发性 MDD 的男性和女性门诊患者接受 16 或 20 次急性期 CT 治疗，以便有足够的能力比较第一年随访的效果。复发风险较高的其他应答者将被随机分配接受 8 个月的：(a) C-CT、(b) FLX 或 (c) PBO，然后随访 2 年；低风险患者将在急性期 CT 后随访 32 个月。因变量衡量反应、复发、复发、缓解和恢复。计划进行盲评估和生存分析。