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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
  Purpose

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 Intervention
Hepatitis C
Depressive Disorder, Major
Depressive Disorder
Depression
HIV Infections
Behavioral: Hepatitis C educational support groups
Behavioral: Cognitive Behavioral Therapy skills based group sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655226

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Thomas G McGinn, MD, MPH Mount Sinai School of Medicine
  More Information

No publications provided

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
Study First Received: April 3, 2008
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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:
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Infection
Behavioral Symptoms
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Mental Disorders
Mood Disorders
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014