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

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ClinicalTrials.gov Identifier: NCT00655226
Recruitment Status : Terminated (low enrollment)
First Posted : April 9, 2008
Last Update Posted : August 9, 2011
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 9, 2008
Last Update Posted Date August 9, 2011
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • Depression measured by PHQ-9 [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 0 week ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 2 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 4 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 8 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 12 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 18 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 24 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 30 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 36 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 42 weeks ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 48 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Depression measured by PHQ-9 [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 2 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 4 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 8 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 12 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 18 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 24 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 30 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 36 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 42 weeks ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 48 weeks ]
  • medication adherence [ Time Frame: study baseline ]
  • medication adherence [ Time Frame: treatment visits 0 week ]
  • medication adherence [ Time Frame: treatment visit 2 weeks ]
  • medication adherence [ Time Frame: treatment visit 4 weeks ]
  • medication adherence [ Time Frame: treatment visit 8 weeks ]
  • medication adherence [ Time Frame: treatment visit 12 weeks ]
  • medication adherence [ Time Frame: treatment visit 18 weeks ]
  • medication adherence [ Time Frame: treatment visit 24 weeks ]
  • medication adherence [ Time Frame: treatment visit 30 weeks ]
  • medication adherence [ Time Frame: treatment visit 36 weeks ]
  • medication adherence [ Time Frame: treatment visit 42 weeks ]
  • medication adherence [ Time Frame: treatment visit 48 weeks ]
  • hepatitis C treatment completion [ Time Frame: study baseline ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 0 week ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 2 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 4 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 8 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 12 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 18 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 24 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 30 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 36 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 42 weeks ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
  • medication adherence [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
  • hepatitis C treatment completion [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Official Title  ICMJE Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Depressive Disorder, Major
  • Depressive Disorder
  • Depression
  • HIV Infections
Intervention  ICMJE
  • Behavioral: Hepatitis C educational support groups
    Hepatitis C educational support groups
  • Behavioral: Cognitive Behavioral Therapy skills based group sessions
    Eight CBT group sessions tailored for hepatitis C patients conducted by a clinical psychologist: 3 sessions conducted prior to IFN/ribavirin initiation, 1 session the day of IFN/ribavirin initiation, and 4 sessions during IFN/ribavirin treatment.
Study Arms  ICMJE
  • Experimental: CBT skills based group sessions
    Cognitive Behavioral Therapy skills based group sessions
    Intervention: Behavioral: Cognitive Behavioral Therapy skills based group sessions
  • Active Comparator: Hepatitis C educational support groups
    Hepatitis C educational support groups
    Intervention: Behavioral: Hepatitis C educational support groups
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
60
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. >21 years
  2. Speak and read English to 5th grade level of higher.
  3. Eligible and ready to begin Peg-Interferon and Ribavirin (PEG-IFN/RBV) therapy for HCV at Mount Sinai's Primary Care practice or JMFC
  4. HIV infected patients will need to have a CD4 count > 100 and have demonstrated compliance to retroviral therapy
  5. Not majorly depressed upon entry to study.
  6. Signed informed consent to participate in CBT study

Exclusion Criteria:

  1. Majorly depressed (based on administration of the PHQ-9, score considered for Major Depressive Disorder).
  2. Admit to actively abusing illicit drugs or alcohol
  3. Medical contraindications to a standard course of interferon/ribavirin therapy (eg: severe anemia, uncontrolled congestive heart failure)
  4. Less than one year of life expectancy
  5. Current participation in CBT related psychotherapy
  6. Participation in any psychotherapy beginning less than 6 months before CBT sessions begin.
  7. Initiated anti-depressant medication less than 6 months before CBT sessions begin
  8. Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
  9. Active suicidal ideation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655226
Other Study ID Numbers  ICMJE GCO# 05-0961
R21DA021531 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas McGinn, MD, MPH, Mount Sinai School of Medicine
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Thomas G McGinn, MD, MPH Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP