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| Sponsors and Collaborators: |
Mount Sinai School of Medicine 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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Depression in HIV/HCV co-Infected Substance Abuse Patients |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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2: Active Comparator
Hepatitis C educational support groups
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Behavioral: Hepatitis C educational support groups
Hepatitis C educational support groups
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Natalie B Kil, MPH | 212-824-7460 | Natalie.kil@mountsinai.org |
| Contact: Jacqueline Arciniega | 212-824-7493 | Jacqueline.arciniega@mountsinai.org |
| United States, New York | |
| Mount SInai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Natalie B Kil, MPH 212-241-4154 natalie.kil@mountsinai. org | |
| Contact: Jacqueline Arciniega 212-241-8622 Jacqueline.arciniega@mountsinai.org | |
| Principal Investigator: Thomas G McGinn, MD, MPH | |
| Sub-Investigator: Lata McGinn, Ph.D. | |
| Sub-Investigator: Ian M Kronish, MD, MPH | |
| Sub-Investigator: Dennis S Charney, MD | |
| Sub-Investigator: Andrew C Aronson, MD | |
| Sub-Investigator: Priya Grewal, MD | |
| Sub-Investigator: Dawn Fishbein, MD, MS | |
| Principal Investigator: | Thomas G McGinn, MD, MPH | Mount Sinai School of Medicine |
More Information
| Responsible Party: | Mount Sinai School of Medicine ( Thomas McGinn, MD, MPH ) |
| Study ID Numbers: | GCO# 05-0961, R21-DA021531 |
| Study First Received: | April 3, 2008 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00655226 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Liver Diseases Sexually Transmitted Diseases, Viral Hepatitis, Chronic Ribavirin Hepatitis, Viral, Human Disorders of Environmental Origin Depressive Disorder, Major Mental Disorders Substance-Related Disorders Hepatitis C Retroviridae Infections Interferon-alpha Depression Interferons |
Acquired Immunodeficiency Syndrome Depressive Disorder Immunologic Deficiency Syndromes Behavioral Symptoms Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Mood Disorders Peginterferon alfa-2a Interferon Alfa-2a Interferon Alfa-2b |
|
Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Flaviviridae Infections Disorders of Environmental Origin Hepatitis, Viral, Human Depressive Disorder, Major Infection Pathologic Processes Mental Disorders Substance-Related Disorders Hepatitis C Retroviridae Infections RNA Virus Infections |
Disease Depression Immune System Diseases Acquired Immunodeficiency Syndrome Depressive Disorder Immunologic Deficiency Syndromes Behavioral Symptoms Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mood Disorders |
