PROPHYLACTIC COGNITIVE THERAPY FOR DEPRESSION

抑郁症的预防性认知疗法

• 批准号: 6682739
• 负责人: ROBIN B JARRETT
• 金额: $ 35.15万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-03 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6682739
• 关键词: behavioral /social science research tag; clinical research; clinical trials; cognitive behavior therapy; combination therapy; cooperative study; fluoxetine; human subject; human therapy evaluation; major depression; mental disorder chemotherapy; model design /development; psychological models; relapse /recurrence

This is a blinded, controlled, randomized clinical trial to evaluate the efficacy of and indications for eight 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. The study will be conducted jointly 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 six weeks of acute phase CT, while "lower" risk is defined as a complete and stable remission (i.e., seven consecutive Hamilton Rating Scale for Depression scores of less than seven). This trial has great public health significance because it will help identify when CT reduces the risk of relapse for patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can be targeted for the most vigorous preventative treatment. This study is also the first to evaluate 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 plus continuation phase CT. Further, the pharmacotherapy group will permit tests of Triode-specific versus nonspecific therapeutic activity. Approximately 340 male and female outpatients, age 18 - 70, with DSM-IV unipolar, nonpsychotic, recurrent MDD will enter 16 sessions of acute phase CT. Approximately 114 responders at higher risk for relapse will be randomized to eight months of (a) C-CT, (b) FLX, or (c) PBO. The lower risk patients (n = 56) will be followed for eight months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations occur at the end of the acute phase and at four and eight months post-acute phase CT, as well as at suspected relapse or exit. Survival analyses are planned.

这是一项盲目，受控的，随机的临床试验，可评估八个月的持续阶段认知疗法（C-CT），药物疗法（Fluoxetine; FLX）和药丸安慰剂（PBO）的疗效，在患有重新出现的重度抑郁症（MDD）的门诊病人中，患有更高风险。 这项研究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共同进行。 “较高的风险”是通过在急性期CT的最后六周内的不完全缓解来定义的，而“较低”的风险定义为完全稳定的缓解（即，连续七个连续七个汉密尔顿的评级量表，小于七个）。该试验具有很高的公共健康意义，因为它将有助于确定CT何时减少患有复发性MDD的患者复发风险，这是一种高发病率和死亡率的疾病。 重复风险最高的患者可以针对最剧烈的预防治疗。 这项研究也是第一个评估连续阶段药物疗法（FLX）后不完全缓解急性期CT后的研究。 这种对比很重要，因为许多患者没有足够的保险覆盖范围来支持急性延续阶段CT的完整过程。 此外，药物治疗组将允许测试三极特异性和非特异性治疗活性。大约340名男性和女性门诊患者，年龄在18-70岁，具有DSM -IV单极，非精神病性，复发性MDD，将进入16次急性期CT。 大约有114名复发风险较高的响应者将被随机分为（a）C-CT，（b）FLX或（c）PBO的八个月。 急性期CT后八个月，较低的风险患者（n = 56）将遵循。 因变量测量反应，复发，复发，缓解和恢复。 盲目评估发生在急性相结束，急性后CT和八个月以及可疑的复发或出口。 计划生存分析。