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

预防 HIV/HCV 合并感染药物滥用患者的抑郁症

• 批准号: 7119895
• 负责人: THOMAS G MCGINN
• 金额: $ 20.91万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7119895
• 关键词: clinical research; depression; experience; interferons; prevention; substance abuse related disorder

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.

描述（由申请人提供）：丙型肝炎（HCV）在经验丰富的患者中很常见，会引起明显的发病率和死亡率，虽然可以使用有效的治疗，但相对较少的启动和完整的治疗。在单声道和HCV/HIV共感染的患者中对HCV的治疗是一个漫长而困难的过程，涉及6至12个月的PEG-LNTerferon注射和口服Ribavirin（PEG-IFN/RBV）。由于药物治疗，超过40％的患者患抑郁症，进而导致中断并失去了预防肝病的机会。认知行为疗法（CBT）是一种公认​​的方式，与抗抑郁药在治疗抑郁症方面相比，其有效或更有效，并且与复发的风险较低有关。 CBT还可以有效治疗由于医学疾病而导致的抑郁症，并防止高危个体的抑郁症。作为一种非药物治疗，通过最大程度地减少副作用以及药物疾病和药物 - 药物相互作用，CBT可以优于HCV中的抗抑郁药。 CBT教学的认知能力也可能有助于增强对HCV和HIV方案的依从性。尽管在PEG-IFN/RBV治疗未抑郁的HCV患者之前和期间的CBT是一种有前途的非药理学方法，可安全地降低抑郁症的速度并增加治疗的依从性，但在这种情况下，其功效尚不清楚。这项研究的目的是开发，完善和评估PILOT CBT干预措施对单人感染/共感染的，不抑郁的患者的初始功效，患有PEG-IFN/RBV治疗的药物滥用经验。 我们的具体目的是执行试点RCT，以将CBT的效果与：1）相比：1）培养CBT组计划的完善和测试可行性2）降低治疗过程中发生的抑郁率，3）增加完成HCV治疗的患者数量。我们将在我们的新CBT干预措施或支持小组补充的新的CBT干预措施中，将60个内城，单声道和共同感染的HCV患者与PEG-IFN/RBV进行计划治疗的HCV患者。在这60名患者中，有20名单人感染和20个共同感染的人将接受CBT，20例将接受控制支持组。干预措施将由训练有素的CBT治疗师领导的8个组会议（每个2小时）。在开始PEG-IFN/RBV之前的两个月中，将进行三个会议。剩下的5次课程将在治疗的前6个月每月举行。患者将在3个月和6个月的基线时完成Beck抑郁量库存和其他经过验证的工具。这项可行性研究的结果将用于进一步完善CBT模块，并设计一项大型的，全功能的随机对照试验，以确定评估其在防止PEG-IFN/RBV相关抑郁症和改善脆弱人群中HCV治疗率的功效。