Status:
TERMINATED
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Hepatitis C
Depressive Disorder, Major
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 mo...
Eligibility Criteria
Inclusion
- \>21 years
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00655226
Start Date
March 1 2008
End Date
May 1 2010
Last Update
August 9 2011
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029