REDUCING DEPRESSIVE SYMPTOMS DURING HCV THERAPY: A RANDOMIZED STUDY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。慢性丙型肝炎（HCV）影响着美国数百万人，在退伍军人中尤为普遍。由于丙型肝炎的高流行率，以及丙型肝炎对健康的许多不良影响，以及它有可能治愈的事实，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。最佳丙型肝炎治疗的主要障碍是最有效的治疗方法——皮下聚乙二醇化干扰素- α (IFN)和口服利巴伐林的结合——有许多严重的副作用，其中许多是神经精神方面的。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抑郁症。我们还建议利用这次试验提供的绝佳机会来扩大我们对IFN诱导的抑郁症和IFN治疗的另一个严重副作用-认知障碍的认识。我们计划在这项多学科、临床为基础的研究中研究总共90名患者。目的：本研究的目的是评估8次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，在使用干扰素和利巴韦林治疗的前六个月，45名在治疗过程早期接受8次就诊干预以及常规护理的患者（实验组）在CES-D（一种标准抑郁评定量表）上的得分低于仅接受常规护理的45名患者（对照组）。从长远来看，我们计划使用该试点研究的数据提交临床科学价值评估，以开展更大规模的HCV患者干预合作试验。如果这项研究证明了这种方法的有效性，它可能是HCV治疗的一个重大进展。

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.