search
Back to results

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

Primary Purpose

Hepatitis C, Depressive Disorder, Major, Depressive Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hepatitis C educational support groups
Cognitive Behavioral Therapy skills based group sessions
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT skills based group sessions

Hepatitis C educational support groups

Arm Description

Cognitive Behavioral Therapy skills based group sessions

Hepatitis C educational support groups

Outcomes

Primary Outcome Measures

Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9
Depression measured by PHQ-9

Secondary Outcome Measures

Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
Depressive symptoms (measured by Beck Depression Inventory-II)
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
medication adherence
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion
hepatitis C treatment completion

Full Information

First Posted
April 3, 2008
Last Updated
August 5, 2011
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00655226
Brief Title
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Official Title
Prevention of Depression in HIV/HCV Co-infected Substance Abuse Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Depressive Disorder, Major, Depressive Disorder, Depression, HIV Infections
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT skills based group sessions
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy skills based group sessions
Arm Title
Hepatitis C educational support groups
Arm Type
Active Comparator
Arm Description
Hepatitis C educational support groups
Intervention Type
Behavioral
Intervention Name(s)
Hepatitis C educational support groups
Intervention Description
Hepatitis C educational support groups
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy skills based group sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression measured by PHQ-9
Time Frame
study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
Title
Depression measured by PHQ-9
Time Frame
treatment visit 0 week
Title
Depression measured by PHQ-9
Time Frame
treatment visit 2 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 4 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 8 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 12 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 18 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 24 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 30 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 36 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 42 weeks
Title
Depression measured by PHQ-9
Time Frame
treatment visit 48 weeks
Secondary Outcome Measure Information:
Title
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)
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 2 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 4 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 8 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 12 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 18 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 24 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 30 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 36 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 42 weeks
Title
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame
treatment visits 48 weeks
Title
medication adherence
Time Frame
study baseline
Title
medication adherence
Time Frame
treatment visits 0 week
Title
medication adherence
Time Frame
treatment visit 2 weeks
Title
medication adherence
Time Frame
treatment visit 4 weeks
Title
medication adherence
Time Frame
treatment visit 8 weeks
Title
medication adherence
Time Frame
treatment visit 12 weeks
Title
medication adherence
Time Frame
treatment visit 18 weeks
Title
medication adherence
Time Frame
treatment visit 24 weeks
Title
medication adherence
Time Frame
treatment visit 30 weeks
Title
medication adherence
Time Frame
treatment visit 36 weeks
Title
medication adherence
Time Frame
treatment visit 42 weeks
Title
medication adherence
Time Frame
treatment visit 48 weeks
Title
hepatitis C treatment completion
Time Frame
study baseline
Title
hepatitis C treatment completion
Time Frame
treatment visit 0 week
Title
hepatitis C treatment completion
Time Frame
treatment visit 2 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 4 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 8 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 12 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 18 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 24 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 30 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 36 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 42 weeks
Title
hepatitis C treatment completion
Time Frame
treatment visit 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G McGinn, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs