Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients (NCT00655226) | Clinical Trial Compass
TerminatedNot Applicable
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Stopped: low enrollment
United States26 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \>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 criteria
✕. 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
What they're measuring
1
Depression measured by PHQ-9
Timeframe: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)