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

Not Applicable

Terminated

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

• Registration Number: NCT00655226
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT skills based group sessions	Cognitive Behavioral Therapy skills based group sessions	Cognitive Behavioral Therapy skills based group sessions
Hepatitis C educational support groups	Hepatitis C educational support groups	Hepatitis C educational support groups

Primary Outcome Measures

Name	Time	Method
Depression measured by PHQ-9	treatment visit 48 weeks

Secondary Outcome Measures

Name	Time	Method
medication adherence	treatment visit 48 weeks
hepatitis C treatment completion	treatment visit 48 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)	treatment visits 48 weeks

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States