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

Sponsor:	Mount Sinai School of Medicine
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00655226

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Depression HIV/AIDS Hepatitis Hepatitis A Hepatitis C Liver Diseases

Drug Information available for: Ribavirin Hepatitis A Vaccines

U.S. FDA Resources

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:

>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
Severe comorbid psychiatric disease including bipolar disorder, severe personality disorder, or psychotic disorder
Active suicidal ideation

Contacts and Locations

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

National Institute on Drug Abuse (NIDA)

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Hepatitis
Hepatitis A
Hepatitis C
Substance-Related Disorders
Depressive Disorder, Major
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012