Preventing Depression in MMT Patients on Interferon

描述（由申请人提供）：迄今为止，尚未探索使用社会心理干预来预防通常由丙型肝炎病毒（HCV）抗病毒治疗引起的重性抑郁发作。然而，抑郁症的认知行为治疗（CBT-D）已经在许多不同的人群中证明了有效性，包括药物滥用者和有医疗问题的个体，并且已经发现在预防抑郁症方面是有效的。本研究项目的长期目标是通过开发和建立针对丙型肝炎患者的CBT-D干预的有效性，改善美沙酮维持治疗（MMT）患者接受干扰素（IFN）治疗的抑郁症预防选择。此外，我们寻求进一步了解抑郁症状与干扰素治疗依从性和非法药物使用复发之间的关系。在目前的申请中，我们建议开发一种CBT-D干预措施，以满足接受丙型肝炎抗病毒治疗的MMT患者的需求。在该项目的第一阶段（第一年），我们将开发和试点20名患者的干预措施。在项目的第二阶段（第2年和第3年），我们将对60名MMT患者进行初步的随机试验，以检查CBT-D干预相对于放松训练（RT）控制条件的疗效，该控制条件等同于治疗师接触时间。我们预计，相对于RT组，随机分配到CBT-D组的参与者抑郁相关抗病毒治疗失败的可能性会降低，抑郁症状水平会降低，会完成更多的IFN注射，HCV RNA水平会降低，使用违禁药物的天数会减少。如果这种干预的有效性可以在本试验和随后的临床试验中得到证实，那么选择接受抗病毒治疗的MMT患者将有一个有价值的辅助或替代使用抗抑郁药来预防抑郁症。如果发现有效，这种干预将最大限度地提高MMT患者接受干扰素治疗的机会，从而有助于预防丙型肝炎患者的肝功能衰竭、肝细胞癌和肝脏相关死亡。

DESCRIPTION (provided by applicant): To date, the use of psychosocial interventions to prevent the major depressive episodes that are commonly precipitated by antiviral treatment for the hepatitis C virus (HCV) has been unexplored. However, cognitive-behavioral treatments for depression (CBT-D) have demonstrated efficacy in a number of different populations, including substance abusers and individuals with medical problems, and have been found to be efficacious in the prevention of depression. The long-term objective of this research program is to improve depression prevention options for methadone maintenance treatment (MMT) patients undergoing interferon (IFN) treatment for hepatitis C by developing and establishing the efficacy of a CBT-D intervention tailored to this population. Furthermore, we seek to advance knowledge of the relationship between depressive symptoms and IFN treatment adherence and illicit drug use relapse. In the present application, we propose to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to the relaxation training (RT) control condition that equates for therapist contact time. We expect that, relative to the RT condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.