CBASP Augmentation for Treatment of Chronic Depression

CBASP 强化治疗慢性抑郁症

• 批准号: 6665405
• 负责人: MICHAEL E THASE
• 金额: $ 79.88万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6665405
• 关键词: antidepressants; chronic disease /disorder; clinical research; clinical trials; 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(申请人提供)：慢性抑郁障碍， 困扰着美国3%到5%的成年人口， 对身体健康有不利影响的潜在致残条件 在社会和职业角色方面的表现。我们团队进行的研究 自1991年以来，记录了50%的急性期意向治疗应答率 对标准的抗抑郁药物和75%的预防性药物进行维护 心理治疗。许多专家建议，心理治疗和治疗的结合 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)，其中结合了 奈法唑酮与慢性抑郁症心理治疗模式的建立 (心理治疗认知行为分析系统；CBASP)是 明显比任何一种单一疗法有效(意向治疗反应 房价：75%对48%对45%)。这些发现是有限的 可概括性，因为该议定书具有高度限制性。 此外，目前还不清楚更昂贵的联合方法最终是否会 导致完全康复的患者比例更高，特别是在 与优化的顺序、算法指导的方法相比， 药物疗法。这也似乎表明，虽然单独使用CBASP可能会有较慢的发病速度 比单纯药物治疗更有效，那些对这种形式的药物有反应的人 心理治疗有更持久的反应。我们现在建议 将这些发现扩展到一项创新的多中心试验中 450名慢性抑郁症患者的代表性样本，这项研究将 包括急性期和持续治疗两个阶段。在急症期间 阶段(持续长达28周)，患者将被随机分为三组 方式：1)序贯算法引导的药物治疗(n=150)，2)CBASP 单纯用药组(n=150)，或药物治疗+CBASP组(n=150)。在这两个急性发作期间 和持续阶段的试验，我们预测联合治疗将产生 在症状、症状(即缓解、恢复和复发)方面的卓越结果 税率)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上进行对比 结果。我们预测综合治疗的额外费用将至少是 部分被更快、更全面的缓解所抵消。我们还预测 单独的药物治疗将比CBASP产生更快的效果(成本更低) 在急性期独自一人，但CBASP小组将在 续展阶段结束。这两个阶段的研究跨越了常规 研究的功效和服务模式，并将对 通过评估这些产品的效用和成本来实现公共健康 有特色的治疗方法。这项研究还将提供 为后续应用程序评估更长期的维护奠定基础 慢性抑郁症的阶段性治疗。