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Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Primary Purpose

Hepatitis C, Depression

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Training

About this trial

This is an interventional prevention trial for Hepatitis C focused on measuring Hepatitis C, HCV, Depression, Interferons, Ribavirin

Eligibility Criteria

25 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligibility and interest in treatment for chronic HCV (Hepatitis C).
Absence of co-infection of HIV or Hepatitis B.
Age 25-68 years old.
No treatment with IFN (interferon-alpha) in the past 6 months.
Residence within a 3-hour drive of the clinic.

Exclusion Criteria:

Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments.
Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be <8.0%.
Patients must not have an active malignancy.
If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider.
Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.
Active alcohol or intravenous drug use is a contraindication to treatment.
Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.
Patients with a known history of coronary heart disease are excluded.
Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of <50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded.
Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.
The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.

Sites / Locations

South Texas Veterans Healthcare System, Audie Murphy Division

Outcomes

Primary Outcome Measures

Patients in the experimental group will have less of an increase in their HAM-D score over the first 6 months of treatment; score on a depression rating scale at study visits 1-5.

Secondary Outcome Measures

Patients in the experimental group will have less of an increase in their PHQ-9 score over the first 6 months of treatment; score on a rating scale at study visits 1-5.

Patients in the experimental group will have less of an increase in their BDI score over the first 6 months of treatment; score on a rating scale at study visits 1-5.

Fewer patients in the experimental group will have developed a major depressive episode over the first 6 months of treatment; score on MDD module (MINI)at study visits 1-5.

Patients in the experimental group will have less of a decline in their self-rated general health (item #1 of the SF-36) over the first 6 months of treatment.

Patients in the experimental group will have less of an increase in self-rated irritability (item #6 of the BSI ) over the first 6 months of treatment.

Full Information

NCT ID

NCT00495768

First Posted

July 2, 2007

Last Updated

December 13, 2007

Sponsor

South Texas Veterans Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT00495768

Brief Title

Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Official Title

Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

South Texas Veterans Health Care System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to conduct a randomized controlled trial of an 8-visit non-pharmacologic group intervention in reducing the severity of depressive symptoms in veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (control group).

Detailed Description

In this study, subjects will be randomly assigned (by chance, like the flipping of a coin) to one of two study groups. Half the subjects will be assigned to a training program, which will consist of 8 sessions over a period of 8 weeks in which they will be instructed in cognitive therapy ( a method of identifying and "talk back" to one's negative thoughts) and a variety of other stress-reducing techniques. The other half will be assigned to a control groups, which will no receive instruction in cognitive therapy or the other stress-reducing techniques. All subjects, both those in the training program and in the control group, will receive the usual care for hepatitis C that all patients in the Hepatology Clinic receive. All subjects will also be asked to participate in 6 testing visits over the course of the study. The first testing visit will last about 3 hours, which the others will last between 1 1/2 and 2 hours. Subjects will alo be interviewed by telephone about their personal and family medical and psychiatric history. This will take about an hour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Depression

Keywords

Hepatitis C, HCV, Depression, Interferons, Ribavirin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Group Training

Intervention Description

Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.

Primary Outcome Measure Information:

Title

Patients in the experimental group will have less of an increase in their HAM-D score over the first 6 months of treatment; score on a depression rating scale at study visits 1-5.

Time Frame

Two years

Secondary Outcome Measure Information:

Title

Patients in the experimental group will have less of an increase in their PHQ-9 score over the first 6 months of treatment; score on a rating scale at study visits 1-5.

Time Frame

Two years

Title

Patients in the experimental group will have less of an increase in their BDI score over the first 6 months of treatment; score on a rating scale at study visits 1-5.

Time Frame

Two years

Title

Fewer patients in the experimental group will have developed a major depressive episode over the first 6 months of treatment; score on MDD module (MINI)at study visits 1-5.

Time Frame

Two years

Title

Patients in the experimental group will have less of a decline in their self-rated general health (item #1 of the SF-36) over the first 6 months of treatment.

Time Frame

Two years

Title

Patients in the experimental group will have less of an increase in self-rated irritability (item #6 of the BSI ) over the first 6 months of treatment.

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eligibility and interest in treatment for chronic HCV (Hepatitis C). Absence of co-infection of HIV or Hepatitis B. Age 25-68 years old. No treatment with IFN (interferon-alpha) in the past 6 months. Residence within a 3-hour drive of the clinic. Exclusion Criteria: Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments. Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be <8.0%. Patients must not have an active malignancy. If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider. Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment. Active alcohol or intravenous drug use is a contraindication to treatment. Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment. Patients with a known history of coronary heart disease are excluded. Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of <50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded. Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects. The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen L. Stern, M.D.

Organizational Affiliation

South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Texas Veterans Healthcare System, Audie Murphy Division

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

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Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

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