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临床试验/NCT00655226
NCT00655226终止不适用

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

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1
主要终点
Depression measured by PHQ-9

研究概览

简要总结

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the prevention of depression during interferon and ribavirin treatment for hepatitis C infection.

详细描述

The treatment for active hepatitis C in both HCV mono-infected and HCV/HIV co-infected patients is a long and difficult course, involving combination therapy of interferon and ribavirin for 6 to 12 months, a therapy with significant side effects. Up to 40% of patients being treated will develop depression due to the medication, which in turn leads to discontinuation of therapy and lost opportunities to prevent end stage liver disease. In fact, the presence of depression prior to interferon treatment often excludes patients from receiving interferon therapy, thereby denying them a potentially life-saving treatment. Non-pharmacological therapies such as cognitive behavioral therapy (CBT) have demonstrated efficacy in treating primary depression in numerous studies including in patients under going treatment with chronic medical illness. CBT is a well-established treatment modality and has been shown in several large randomized trials to be as effective, and in some cases more effective, than antidepressants. CBT has also shown efficacy in preventing the development of depression and other emotional disorders in high-risk populations. Offering CBT prior to and during treatment with interferon to non-depressed patients is a unique method that may reduce rates of depression and increase adherence to treatment without exposing patients to the risk of an additional medication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Speak and read English to 5th grade level of higher.
  • Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC
  • HIV infected patients will need to have a CD4 count > 100 and have demonstrated compliance to retroviral therapy
  • Not majorly depressed upon entry to study.
  • Signed informed consent to participate in CBT study

排除标准

  • Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder).
  • Admit to actively abusing illicit drugs or alcohol
  • Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure)
  • Less than one year of life expectancy
  • Current participation in CBT related psychotherapy
  • Participation in any psychotherapy beginning less than 6 months before CBT sessions begin.
  • Initiated anti-depressant medication less than 6 months before CBT sessions begin
  • Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
  • Active suicidal ideation

结局指标

主要结局

Depression measured by PHQ-9

时间窗: treatment visit 48 weeks

次要结局

  • medication adherence(treatment visit 48 weeks)
  • hepatitis C treatment completion(treatment visit 48 weeks)
  • Depressive symptoms (measured by Beck Depression Inventory-II)(treatment visits 48 weeks)

研究者

申办方类型
Other

研究点 (1)

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