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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatitis C, Depressive Disorder, Major, Depressive Disorder, Depression, HIV Infections

Intervention / Treatment
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* Behavioral: Hepatitis C educational support groups
* Behavioral: Cognitive Behavioral Therapy skills based group sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT skills based group sessions<br>Cognitive Behavioral Therapy skills based group sessions | Behavioral: Cognitive Behavioral Therapy skills based group sessions<br>* 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.<br>|
| Active Comparator: Hepatitis C educational support groups<br>Hepatitis C educational support groups | Behavioral: Hepatitis C educational support groups<br>* Hepatitis C educational support groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression measured by PHQ-9 |  | study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) | 
| Depression measured by PHQ-9 |  | treatment visit 0 week | 
| Depression measured by PHQ-9 |  | treatment visit 2 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 4 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 8 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 12 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 18 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 24 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 30 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 36 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 42 weeks | 
| Depression measured by PHQ-9 |  | treatment visit 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks) | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 2 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 4 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 8 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 12 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 18 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 24 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 30 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 36 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 42 weeks | 
| Depressive symptoms (measured by Beck Depression Inventory-II) |  | treatment visits 48 weeks | 
| medication adherence |  | study baseline | 
| medication adherence |  | treatment visits 0 week | 
| medication adherence |  | treatment visit 2 weeks | 
| medication adherence |  | treatment visit 4 weeks | 
| medication adherence |  | treatment visit 8 weeks | 
| medication adherence |  | treatment visit 12 weeks | 
| medication adherence |  | treatment visit 18 weeks | 
| medication adherence |  | treatment visit 24 weeks | 
| medication adherence |  | treatment visit 30 weeks | 
| medication adherence |  | treatment visit 36 weeks | 
| medication adherence |  | treatment visit 42 weeks | 
| medication adherence |  | treatment visit 48 weeks | 
| hepatitis C treatment completion |  | study baseline | 
| hepatitis C treatment completion |  | treatment visit 0 week | 
| hepatitis C treatment completion |  | treatment visit 2 weeks | 
| hepatitis C treatment completion |  | treatment visit 4 weeks | 
| hepatitis C treatment completion |  | treatment visit 8 weeks | 
| hepatitis C treatment completion |  | treatment visit 12 weeks | 
| hepatitis C treatment completion |  | treatment visit 18 weeks | 
| hepatitis C treatment completion |  | treatment visit 24 weeks | 
| hepatitis C treatment completion |  | treatment visit 30 weeks | 
| hepatitis C treatment completion |  | treatment visit 36 weeks | 
| hepatitis C treatment completion |  | treatment visit 42 weeks | 
| hepatitis C treatment completion |  | treatment visit 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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