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

描述(申请人提供)：丙型肝炎(丙型肝炎)在有药物滥用经验的患者中很常见，会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和完全治疗。对单一感染者和丙型肝炎病毒/艾滋病病毒混合感染者的丙型肝炎病毒的治疗是一个漫长而困难的过程，需要6至12个月的聚乙二醇干扰素注射和口服利巴韦林(聚乙二醇化干扰素/RBV)。超过40%的患者因药物治疗而患上抑郁症，这反过来又会导致停药并失去预防肝病的机会。认知行为疗法(CBT)是一种公认的方法，在治疗抑郁症方面被证明与抗抑郁药物一样有效，或者更有效，并且与较低的复发风险有关。CBT在治疗内科疾病引起的抑郁症和预防高危人群抑郁方面也很有效。作为一种非药物治疗，CBT在减少副作用、减少药物-疾病和药物-药物相互作用方面可能优于抗抑郁药物。CBT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方案的坚持。虽然在非抑郁的丙型肝炎患者的聚乙二醇-干扰素/RBV治疗前和治疗期间进行CBT是一种有前途的非药物方法，可以安全地降低抑郁症的发生率并增加对治疗的依从性，但它在这种情况下的有效性尚不清楚。这项研究的目的是开发、改进和评估试点CBT干预在有药物滥用经历的单感染/混合感染、非抑郁患者中的初步疗效。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、完善和测试CBT组计划的可行性；2)减少治疗期间发生的抑郁症的发生率；3)增加完成丙型肝炎治疗的患者数量。我们将随机将60名有药物滥用经历的内城、单一和混合感染的丙型肝炎患者计划使用聚乙二醇-干扰素/RBV治疗，加入我们新的CBT干预或常规护理辅助支持组。在这60名患者中，20名单一感染者和20名混合感染者将接受CBT，20名将接受对照支持组。干预将有8个小组会议(每个2小时)，由一名训练有素的CBT治疗师领导。在开始使用聚乙二醇化干扰素/RBV之前的两个月内将进行三次治疗。剩下的5个疗程将在治疗的前6个月按月进行。患者将在基线、3个月和6个月时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被用于进一步改进CBT模块，并设计一项大型、全功率随机对照试验，以最终评估其在预防聚乙二醇型干扰素/RBV相关性抑郁症和提高脆弱人群中丙型肝炎治疗完成率方面的有效性。

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.