REDUCING DEPRESSIVE SYMPTOMS DURING HCV THERAPY: A RANDOMIZED STUDY

减少 HCV 治疗期间的抑郁症状：一项随机研究

• 批准号: 7627545
• 负责人: STEPHEN STERN
• 金额: $ 4.53万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7627545
• 关键词: Adverse effects; Affect; Caring; Chronic Hepatitis C; Clinic; Clinical Sciences; Computer Retrieval of Information on Scientific Projects Database; Control Groups; Data; Disease; Early Intervention; Funding; Grant; Health; Hepatitis C virus; High Prevalence; Impaired cognition; Individual; Institution; Interferon-alpha; Intervention; Knowledge; Mental Depression; Nature; Numbers; Oral; Patients; Pegylated Interferon Alfa; Pilot Projects; Randomized; Rate; Research; Research Personnel; Resources; Ribavirin; Score; Severities; Source; Standards of Weights and Measures; United States National Institutes of Health; Veterans; Visit; base; collaborative trial; depressive symptoms; health administration; neuropsychiatry; subcutaneous

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic hepatitis C (HCV) affects millions of individuals in the U.S. and is especially prevalent among veterans. Because of this high prevalence, as well as the many adverse effects of HCV on health and the fact that it is potentially curable, the Veterans Health Administration has made treatment of this disease one of its top priorities. The major impediment to optimal HCV treatment is that the most effective therapy - a combination of subcutaneous pegylated interferon-alpha (IFN) and oral ribavarin - has a number of serious side effects, many of which are neuropsychiatric in nature. In this pilot project, we propose to develop a non-pharmacologic intervention to minimize the most serious of these, which is depression. We also propose to use the excellent opportunity provided by this trial to expand our knowledge about IFN-induced depression and another serious side effect of IFN treatment - cognitive impairment. We plan to study a total of 90 patients in this multi-disciplinary, clinic-based study. OBJECTIVE: The objective of this study is to evaluate the efficacy of an 8-visit non-pharmacologic group intervention in reducing the severity of depressive symptoms in veterans who receive IFN and ribavirin for the treatment of HCV. We hypothesize that over the first six months of treatment with IFN and ribavirin, the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (the experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (the control group). In the longer term, we plan to use the data from this pilot study to submit a Clinical Science Merit Review to conduct a larger, collaborative trial of our intervention in patients with HCV. If that study demonstrates the efficacy of such an approach, it could be a significant advance in the treatment of HCV.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 慢性丙型肝炎（HCV）影响美国数百万人，在退伍军人中尤其普遍。 由于这种高流行率，以及HCV对健康的许多不利影响，以及它可能是可治愈的事实，退伍军人健康管理局已将治疗这种疾病作为其首要任务之一。 最佳HCV治疗的主要障碍是最有效的治疗-皮下聚乙二醇干扰素α（IFN）和口服利巴韦林的组合-具有许多严重的副作用，其中许多是神经精神性的。 在这个试点项目中，我们建议开发一种非药物干预，以尽量减少其中最严重的，这是抑郁症。 我们还建议利用本试验提供的绝佳机会，扩大我们对IFN诱导的抑郁症和IFN治疗的另一个严重副作用-认知障碍的了解。 我们计划在这项多学科、基于临床的研究中共研究90例患者。 目的：本研究的目的是评估8次访视的非药物组干预在降低接受干扰素和利巴韦林治疗HCV的退伍军人抑郁症状严重程度方面的疗效。 我们假设，在IFN和利巴韦林治疗的前六个月，45例患者在治疗过程中接受8次干预，除了常规护理（实验组），将有较低的评分的CES-D，一个标准的抑郁症评定量表，比45例患者谁只接受常规护理（对照组）。 从长远来看，我们计划使用这项试点研究的数据提交临床科学价值审查，以进行更大规模的合作试验，对HCV患者进行干预。 如果这项研究证明了这种方法的有效性，它可能是治疗HCV的一个重大进展。