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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder; Depression; HIV Infections; Hepatitis C; Depressive Disorder, Major
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy skills based group sessions; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Hepatitis C educational support groups; Hepatitis C educational support groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Thomas G McGinn, MD, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): August 9, 2011
• Last Update Submitted That Met QC Criteria: August 5, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Depression; Infection; Mood Disorders; Depressive Disorder; Hepatitis C; Hepatitis; Interferons; Liver Diseases; Ribavirin; Interferon Alfa-2a; Depressive Disorder, Major; Cognitive Behavior Therapy; Interferon-alpha; Communicable Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Peginterferon alfa-2a; Interferon Alfa-2b
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Mood Disorders; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Substance-Related Disorders; Depression; Depressive Disorder; Disease; Hepatitis; Hepatitis C; Depressive Disorder, Major
• Other Study ID Numbers: GCO# 05-0961; R21DA021531 (U.S. NIH Grant/Contract)