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

Stopped early · Not applicable

Conditions studied: Hepatitis C, Depressive Disorder, Major, Depressive Disorder, Depression, HIV Infections

In brief

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.

Key facts

Study ID

NCT00655226

Run by

Icahn School of Medicine at Mount Sinai

People needed

26

Starts

2008-03-01

Expected to finish

2010-05-01

Last updated by the study team

2011-08-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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