CBASP Augmentation for Treatment of Chronic Depression

CBASP 强化治疗慢性抑郁症

• 批准号: 6434636
• 负责人: MICHAEL E THASE
• 金额: $ 81.07万
• 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/6434636
• 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， 美国3%到5%的成年人都患有这种疾病，是 对身体健康产生不利影响的潜在残疾状况， 在社会和职业角色上的表现。我们团队进行的研究 自1991年以来，已有50%的急性期意向治疗反应率 标准的抗抑郁药物和75%的预防与维护 疗法许多专家建议将心理治疗和 药物疗法可能是慢性抑郁症的最佳治疗， 事实上，我们已经完成了一项研究（n=681），其中， 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（Cognitive Behavioral Analysis System of psychotherapy，CBASP） 比任何一种单药治疗显著更有效（意向治疗反应 比率：75% vs. 48% vs. 45%）。这些发现限制了 由于协议的高度限制性，因此具有普遍性。 此外，目前还不清楚更昂贵的综合方法最终是否 导致完全康复的患者比例更高，特别是当 与优化的顺序、算法指导的方法相比， 药物治疗.此外，CBASP单独使用时， 比单独的药物治疗更有效，那些对这种形式的治疗有反应的人， 心理治疗有更持久或持久的反应。我们现建议 在一项创新的多中心试验中扩展了这些发现， 450名慢性抑郁症患者的代表性样本，该研究将 包括治疗的急性阶段和持续阶段。在急性 阶段（持续长达28周），患者将被随机分配至以下三组之一： 方式：1）序贯算法引导的药物治疗（n=150），2）CBASP 单药治疗组（n=150），药物治疗加CBASP治疗组（n=150）。在急性期， 我们预测，联合治疗将产生 上级症状、综合征（即，缓解、恢复和复发 率）和功能性措施。在整个研究期间，治疗 将对各种生活质量和健康经济进行对比 结果。我们预测，联合治疗的额外费用至少为 部分被更快和更彻底的缓解所抵消。我们还预计 单独的药物治疗比CBASP具有更快的效果（成本更低） 在急性期单独使用，但CBASP组将“赶上” 延续阶段的结束。这两个阶段的研究桥梁传统 研究的效率和服务模式，并将产生重大影响， 公共卫生通过评估这两个效用和成本， 良好的治疗方法。该研究还将提供 为后续应用评估长期维护奠定基础 慢性抑郁症的阶段性治疗