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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Depressive Disorder, Major Depressive Disorder Depression HIV Infections Behavioral: Hepatitis C educational support groups Behavioral: Cognitive Behavioral Therapy skills based group sessions Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Study Start Date : March 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: CBT skills based group sessions
Cognitive Behavioral Therapy skills based group sessions
 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.
Active Comparator: Hepatitis C educational support groups
Hepatitis C educational support groups
 Behavioral: Hepatitis C educational support groups
Hepatitis C educational support groups


Outcome Measures
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Primary Outcome Measures :
  1. Depression measured by PHQ-9 [ Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) ]
  2. Depression measured by PHQ-9 [ Time Frame: treatment visit 0 week ]
  3. Depression measured by PHQ-9 [ Time Frame: treatment visit 2 weeks ]
  4. Depression measured by PHQ-9 [ Time Frame: treatment visit 4 weeks ]
  5. Depression measured by PHQ-9 [ Time Frame: treatment visit 8 weeks ]
  6. Depression measured by PHQ-9 [ Time Frame: treatment visit 12 weeks ]
  7. Depression measured by PHQ-9 [ Time Frame: treatment visit 18 weeks ]
  8. Depression measured by PHQ-9 [ Time Frame: treatment visit 24 weeks ]
  9. Depression measured by PHQ-9 [ Time Frame: treatment visit 30 weeks ]
  10. Depression measured by PHQ-9 [ Time Frame: treatment visit 36 weeks ]
  11. Depression measured by PHQ-9 [ Time Frame: treatment visit 42 weeks ]
  12. Depression measured by PHQ-9 [ Time Frame: treatment visit 48 weeks ]

Secondary Outcome Measures :
  1. 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) ]
  2. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 2 weeks ]
  3. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 4 weeks ]
  4. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 8 weeks ]
  5. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 12 weeks ]
  6. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 18 weeks ]
  7. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 24 weeks ]
  8. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 30 weeks ]
  9. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 36 weeks ]
  10. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 42 weeks ]
  11. Depressive symptoms (measured by Beck Depression Inventory-II) [ Time Frame: treatment visits 48 weeks ]
  12. medication adherence [ Time Frame: study baseline ]
  13. medication adherence [ Time Frame: treatment visits 0 week ]
  14. medication adherence [ Time Frame: treatment visit 2 weeks ]
  15. medication adherence [ Time Frame: treatment visit 4 weeks ]
  16. medication adherence [ Time Frame: treatment visit 8 weeks ]
  17. medication adherence [ Time Frame: treatment visit 12 weeks ]
  18. medication adherence [ Time Frame: treatment visit 18 weeks ]
  19. medication adherence [ Time Frame: treatment visit 24 weeks ]
  20. medication adherence [ Time Frame: treatment visit 30 weeks ]
  21. medication adherence [ Time Frame: treatment visit 36 weeks ]
  22. medication adherence [ Time Frame: treatment visit 42 weeks ]
  23. medication adherence [ Time Frame: treatment visit 48 weeks ]
  24. hepatitis C treatment completion [ Time Frame: study baseline ]
  25. hepatitis C treatment completion [ Time Frame: treatment visit 0 week ]
  26. hepatitis C treatment completion [ Time Frame: treatment visit 2 weeks ]
  27. hepatitis C treatment completion [ Time Frame: treatment visit 4 weeks ]
  28. hepatitis C treatment completion [ Time Frame: treatment visit 8 weeks ]
  29. hepatitis C treatment completion [ Time Frame: treatment visit 12 weeks ]
  30. hepatitis C treatment completion [ Time Frame: treatment visit 18 weeks ]
  31. hepatitis C treatment completion [ Time Frame: treatment visit 24 weeks ]
  32. hepatitis C treatment completion [ Time Frame: treatment visit 30 weeks ]
  33. hepatitis C treatment completion [ Time Frame: treatment visit 36 weeks ]
  34. hepatitis C treatment completion [ Time Frame: treatment visit 42 weeks ]
  35. hepatitis C treatment completion [ Time Frame: treatment visit 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655226


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Thomas G McGinn, MD, MPH Icahn School of Medicine at Mount Sinai
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Thomas McGinn, MD, MPH, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00655226     History of Changes
Other Study ID Numbers: GCO# 05-0961
R21DA021531 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Icahn School of Medicine at Mount Sinai:
Cognitive Behavior Therapy
Interferon-alpha
Communicable Diseases
Liver Diseases
Depression
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
 Infection
Hepatitis
Mood Disorders
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Depressive Disorder, Major
Depressive Disorder

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Hepatitis
Hepatitis C
HIV Infections
Substance-Related Disorders
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Interferons
Ribavirin
Interferon-alpha
Antineoplastic Agents
Antiviral Agents