Prevention of Depression in HIV/HCV co-infected Substance Abuse Patients

描述（由申请人提供）：丙型肝炎（HCV）在有药物滥用经历的患者中很常见，导致显著的发病率和死亡率，虽然有有效的治疗方法，但相对较少的人开始并完成治疗。对于HCV单感染者和HCV/HIV合并感染者，治疗HCV是一个漫长而艰难的过程，涉及6至12个月的peg -干扰素注射和口服利巴韦林（PEG-IFN/RBV）。超过40%的患者因服药而患上抑郁症，进而导致停药并失去预防肝病的机会。认知行为疗法（CBT）是一种公认的治疗方法，在治疗抑郁症方面与抗抑郁药物一样有效，甚至更有效，而且复发的风险更低。CBT在治疗由医学疾病引起的抑郁症和预防高危人群的抑郁症方面也很有效。作为一种非药物治疗，CBT可能优于抗抑郁药物治疗丙型肝炎，因为它最大限度地减少了副作用、药物-疾病和药物-药物相互作用。认知行为疗法教授的认知技能也可能有助于加强对丙型肝炎病毒和艾滋病毒治疗方案的依从性。虽然在PEG-IFN/RBV治疗非抑郁症HCV患者之前和期间的CBT是一种有希望的、安全降低抑郁症发生率和增加治疗依从性的非药物方法，但其在这种情况下的疗效尚不清楚。本研究的目的是发展、完善和评估CBT试点干预在药物滥用经历的单感染/合并感染、非抑郁患者接受PEG-IFN/RBV治疗的初步疗效。我们的具体目标是进行一项试验性随机对照试验，以比较CBT的效果：1)开发完善并测试群体CBT计划的可行性2)降低治疗期间发生的抑郁症发生率3)增加完成HCV治疗的患者数量。我们将随机选择60名有药物滥用经历的内城、单一和合并感染的HCV患者，计划使用PEG-IFN/RBV进行治疗，并将其纳入我们的新CBT干预或支持小组辅助的常规治疗。在这60名患者中，20名单一感染者和20名合并感染者将接受CBT治疗，20名将接受控制支持组。干预将有8个小组会议（每个2小时），由训练有素的CBT治疗师领导。在开始使用PEG-IFN/RBV之前的2个月内将进行3次治疗。在治疗的前6个月，其余5次疗程将按月进行。患者将在基线、3个月和6个月完成贝克抑郁量表和其他有效工具。这项可行性研究的结果将用于进一步完善CBT模块，并设计一项大型、全动力的随机对照试验，以明确评估其在预防PEG-IFN/RBV相关抑郁症和提高弱势人群HCV治疗完成率方面的疗效。

DESCRIPTION (provided by applicant): Hepatitis C (HCV) is common among substance abuse experienced patients, causes significant morbidity and mortality, and while effective treatment is available, relatively few initiate and complete therapy. Treatment for HCV in both mono and HCV/HIV co-infected patients is a long and difficult course, involving 6 to 12 months of Peg-lnterferon injections and oral Ribavirin (PEG-IFN/RBV). Over 40% of patients develop depression due to the medication, which in turn leads to discontinuation and lost opportunities to prevent liver disease. Cognitive Behavioral Therapy (CBT) is a well-established modality shown to be as effective, or more effective, than antidepressant medications in treating depression and is associated with a lower risk of relapse. CBT is also effective in treating depression due to medical disease and preventing depression in high-risk individuals. As a non-pharmacologic therapy, CBT may be superior to antidepressant drugs in HCV by minimizing side effects, and drug-disease and drug-drug interactions. The cognitive skills CBT teaches may also help bolster adherence with HCV and HIV regimens. While CBT prior to and during PEG-IFN/RBV treatment of non-depressed HCV patients is a promising, non-pharmacological method for safely reducing rates of depression and increasing adherence with treatment, its efficacy in this setting is unknown. The purpose of this study is to develop, refine, and evaluate the initial efficacy of pilot CBT intervention in mono-infected/co-infected, non-depressed patients with substance abuse experience being treated with PEG-IFN/RBV. Our specific aims are to perform a pilot RCT to compare the effect of CBT to: 1) Develop refine and test feasibility of a program of group CBT 2)reduce the rate of depression that occurs during treatment, 3) increase the number of patients completing HCV treatment. We will randomize 60 inner city, mono and co-infected HCV patients with substance abuse experience planning treatment with PEG-IFN/RBV to our new CBT intervention or usual care supplemented by support group. Of these 60 patients, 20 mono- infected and 20 co-infected individuals will receive CBT, and 20 will receive control support group. The intervention will have 8 group sessions (2 hours each) led by a trained CBT therapist. Three sessions will occur in the 2 months before starting PEG-IFN/RBV. The remaining 5 sessions will be monthly during the first 6 months of treatment. Patients will complete the Beck Depression Inventory and other validated instruments at baseline, 3 and 6 months. The results of this feasibility study will be used to further refine the CBT modules and design a large, fully-powered randomized controlled trial to definitively assess its efficacy in preventing PEG-IFN/RBV associated depression and improving HCV treatment completion rates among vulnerable populations.