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

This study has been terminated.
(low enrollment)
Sponsor:
Collaborator:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00655226
First received: April 3, 2008
Last updated: August 5, 2011
Last verified: August 2011

April 3, 2008
August 5, 2011
March 2008
May 2010   (final data collection date for primary outcome measure)
  • Depression measured by PHQ-9 [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 0 week ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 2 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 4 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 8 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 12 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 18 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 24 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 30 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 36 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 42 weeks ] [ Designated as safety issue: No ]
  • Depression measured by PHQ-9 [ Time Frame: treatment visit 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655226 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 2 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 4 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 8 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 12 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 18 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 24 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 30 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 36 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 42 weeks ] [ Designated as safety issue: No ]
  • Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 48 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: study baseline ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visits 0 week ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 2 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 4 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 8 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 12 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 18 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 24 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 30 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 36 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 42 weeks ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: treatment visit 48 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: study baseline ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 0 week ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 2 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 4 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 8 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 12 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 18 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 24 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 30 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 36 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 42 weeks ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: treatment visit 48 weeks ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ] [ Designated as safety issue: No ]
  • hepatitis C treatment completion [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Depressive Disorder, Major
  • Depressive Disorder
  • Depression
  • HIV Infections
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00655226
GCO# 05-0961, R21DA021531
Yes
Thomas McGinn, MD, MPH, Mount Sinai School of Medicine
Mount Sinai School of Medicine
National Institute on Drug Abuse (NIDA)
Principal Investigator: Thomas G McGinn, MD, MPH Mount Sinai School of Medicine
Mount Sinai School of Medicine
August 2011

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