CBASP Augmentation for Treatment of Chronic Depression

CBASP 强化治疗慢性抑郁症

• 批准号: 6902669
• 负责人: MARTIN B KELLER
• 金额: $ 32.5万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-24 至 2006-08-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6902669
• 关键词: antidepressants; chronic disease /disorder; clinical research; cognitive behavior therapy; combination therapy; cooperative study; cost effectiveness; depression; health economics; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; outcomes research; patient oriented research; psychotherapy; quality of life; relapse /recurrence; remission /regression; triazoles

DESCRIPTION (provided by applicant): The chronic depressive disorders, which afflict 3 percent to 5 percent of the adult population of the U.S., are potentially disabling conditions that adversely affect physical health and performance in social and vocational roles. Research conducted by our team since 1991 has documented 50 percent acute phase intent-to-treat response rates to standard antidepressants and 75 percent prophylaxis with maintenance therapy. Many experts have suggested that a combination of psychotherapy and pharmacotherapy may be the optimal treatment for chronic depression and, indeed, we have completed a study (n=681) in which the combination of nefazodone and a model of psychotherapy developed for chronic depression (Cognitive Behavioral Analysis System of Psychotherapy; CBASP) was significantly more effective than either monotherapy (intent-to-treat response rates: 75 percent vs. 48 percent vs. 45 percent). These findings have limited generalizability because of the highly restrictive nature of the protocol. Moreover, it is not clear if the more expensive combined approach ultimately results in a greater proportion of fully recovered patients, especially when compared to an optimized sequential, algorithm-guided approach to pharmacotherapy. It also appears that while CBASP alone may have a slower onset of action than pharmacotherapy alone, those who do respond to this form of psychotherapy have a more durable or enduring response. We now propose to extend these findings in an innovative multicenter trial of a diverse and representative sample of 450 chronically depressed patients, The study will encompass both acute and continuation phases of treatment. During the acute phase (lasting up to 28 weeks), patients will be randomized to one of three modalities: 1) sequential algorithm-guided pharmacotherapy (n=150), 2) CBASP alone (n=150), or 3) pharmacotherapy plus CBASP (n=150). During both the acute and continuation phase trials we predict that combined treatment will yield superior outcomes on symptom, syndromal (i.e., remission, recovery, and relapse rates), and functional measures. Across the full study duration, the treatments will be contrasted on a variety of quality of life and health economic outcomes. We predict that the extra cost of combined treatment will be at least partly offset by faster and more complete remissions. We also predict pharmacotherapy alone will have faster effects (at lower costs) than CBASP alone during the acute phase but that the CBASP group will "catch up" by the end of the continuation phase. This two stage study bridges conventional efficacy and services models of research and will make a significant impact on public health by evaluating both the utility and cost of these well-characterized treatment approaches. The study also will provide the foundation for a subsequent application evaluating longer term, maintenance phase treatments of chronic depression.

描述（由申请人提供）：慢性抑郁症， 困扰着美国 3% 到 5% 的成年人口 可能对身体健康产生不利影响的残疾状况 社会和职业角色的表现。我们团队进行的研究 自 1991 年以来记录的急性期意向治疗反应率为 50% 标准抗抑郁药和 75% 的预防与维持 治疗。许多专家建议将心理治疗与治疗相结合。 药物疗法可能是慢性抑郁症的最佳治疗方法， 事实上，我们已经完成了一项研究（n=681），其中结合 奈法唑酮和针对慢性抑郁症开发的心理治疗模型 （心理治疗认知行为分析系统；CBASP） 比任一单一疗法（意向治疗反应）显着更有效 率：75% vs. 48% vs. 45%）。这些发现有限 由于协议的高度限制性，因此具有普遍性。 此外，尚不清楚更昂贵的组合方法最终是否会 导致完全康复的患者比例更高，尤其是当 与优化的顺序、算法引导的方法相比 药物治疗。似乎单独使用 CBASP 可能起效较慢 比单独的药物治疗更有效，那些对这种形式有反应的人 心理治疗有更持久或持久的反应。我们现在建议 在一项创新的多中心试验中扩展这些发现，该试验涉及多种和 450 名慢性抑郁症患者的代表性样本，该研究将 包括治疗的急性期和持续期。急性期期间 阶段（持续长达 28 周），患者将被随机分配至三组之一 方式：1) 序贯算法引导的药物治疗 (n=150)，2) CBASP 单独治疗 (n=150)，或 3) 药物治疗加 CBASP (n=150)。在这两个急性期 和持续阶段试验，我们预测联合治疗将产生效果 症状、综合征（即缓解、恢复和复发）的优异结果 率）和功能措施。在整个研究期间，治疗 将在各种生活质量和健康经济方面进行对比 结果。我们预计联合治疗的额外费用至少为 部分被更快和更完全的缓解所抵消。我们还预测 单独的药物治疗比 CBASP 效果更快（成本更低） 在急性期独自一人，但 CBASP 小组将“赶上” 继续阶段结束。这两个阶段的研究跨越了传统的 研究的功效和服务模式将对 通过评估这些的效用和成本来公共卫生 特征明确的治疗方法。该研究还将提供 为后续应用评估长期、维护奠定基础 慢性抑郁症的阶段治疗。