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

August 5, 2011 updated by: Icahn School of Medicine at Mount Sinai
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Depression measured by PHQ-9
Time Frame: study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
study baseline, treatment visits (0, 2, 4, 8, 12, 18, 24, 30, 36, 42, and 48 weeks)
Depression measured by PHQ-9
Time Frame: treatment visit 0 week
treatment visit 0 week
Depression measured by PHQ-9
Time Frame: treatment visit 2 weeks
treatment visit 2 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 4 weeks
treatment visit 4 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 8 weeks
treatment visit 8 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 12 weeks
treatment visit 12 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 18 weeks
treatment visit 18 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 24 weeks
treatment visit 24 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 30 weeks
treatment visit 30 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 36 weeks
treatment visit 36 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 42 weeks
treatment visit 42 weeks
Depression measured by PHQ-9
Time Frame: treatment visit 48 weeks
treatment visit 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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)
Time Frame: treatment visits 2 weeks
treatment visits 2 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 4 weeks
treatment visits 4 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 8 weeks
treatment visits 8 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 12 weeks
treatment visits 12 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 18 weeks
treatment visits 18 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 24 weeks
treatment visits 24 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 30 weeks
treatment visits 30 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 36 weeks
treatment visits 36 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 42 weeks
treatment visits 42 weeks
Depressive symptoms (measured by Beck Depression Inventory-II)
Time Frame: treatment visits 48 weeks
treatment visits 48 weeks
medication adherence
Time Frame: study baseline
study baseline
medication adherence
Time Frame: treatment visits 0 week
treatment visits 0 week
medication adherence
Time Frame: treatment visit 2 weeks
treatment visit 2 weeks
medication adherence
Time Frame: treatment visit 4 weeks
treatment visit 4 weeks
medication adherence
Time Frame: treatment visit 8 weeks
treatment visit 8 weeks
medication adherence
Time Frame: treatment visit 12 weeks
treatment visit 12 weeks
medication adherence
Time Frame: treatment visit 18 weeks
treatment visit 18 weeks
medication adherence
Time Frame: treatment visit 24 weeks
treatment visit 24 weeks
medication adherence
Time Frame: treatment visit 30 weeks
treatment visit 30 weeks
medication adherence
Time Frame: treatment visit 36 weeks
treatment visit 36 weeks
medication adherence
Time Frame: treatment visit 42 weeks
treatment visit 42 weeks
medication adherence
Time Frame: treatment visit 48 weeks
treatment visit 48 weeks
hepatitis C treatment completion
Time Frame: study baseline
study baseline
hepatitis C treatment completion
Time Frame: treatment visit 0 week
treatment visit 0 week
hepatitis C treatment completion
Time Frame: treatment visit 2 weeks
treatment visit 2 weeks
hepatitis C treatment completion
Time Frame: treatment visit 4 weeks
treatment visit 4 weeks
hepatitis C treatment completion
Time Frame: treatment visit 8 weeks
treatment visit 8 weeks
hepatitis C treatment completion
Time Frame: treatment visit 12 weeks
treatment visit 12 weeks
hepatitis C treatment completion
Time Frame: treatment visit 18 weeks
treatment visit 18 weeks
hepatitis C treatment completion
Time Frame: treatment visit 24 weeks
treatment visit 24 weeks
hepatitis C treatment completion
Time Frame: treatment visit 30 weeks
treatment visit 30 weeks
hepatitis C treatment completion
Time Frame: treatment visit 36 weeks
treatment visit 36 weeks
hepatitis C treatment completion
Time Frame: treatment visit 42 weeks
treatment visit 42 weeks
hepatitis C treatment completion
Time Frame: treatment visit 48 weeks
treatment visit 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas G McGinn, MD, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO# 05-0961
  • R21DA021531 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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