Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by South Texas Veterans Health Care System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
South Texas Veterans Health Care System
ClinicalTrials.gov Identifier:
NCT00495768
First received: July 2, 2007
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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).


Condition Intervention
Hepatitis C
Depression
Behavioral: Group Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Resource links provided by NLM:


Further study details as provided by South Texas Veterans Health Care System:

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. [ Time Frame: Two years ] [ Designated as safety issue: No ]

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. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2004
Estimated Study Completion Date: December 2007
Intervention Details:
    Behavioral: Group Training
    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.
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.

  Eligibility

Ages Eligible for Study:   25 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495768

Locations
United States, Texas
South Texas Veterans Healthcare System, Audie Murphy Division
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
South Texas Veterans Health Care System
Investigators
Principal Investigator: Stephen L. Stern, M.D. South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio
  More Information

Publications:
Akaike H. A new look at the statistical identification model. IEEE, Tranactions Auto Control 1974;19:716-23
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), Washington, DC, 2000.

Responsible Party: Dr, Stephen L. Stern, Audie L. Murphy VA Hospital
ClinicalTrials.gov Identifier: NCT00495768     History of Changes
Other Study ID Numbers: 034-0013-391
Study First Received: July 2, 2007
Last Updated: December 13, 2007
Health Authority: United States: Federal Government

Keywords provided by South Texas Veterans Health Care System:
Hepatitis C
HCV
Depression
Interferons
Ribavirin

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hepatitis
Hepatitis C
Behavioral Symptoms
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
Mood Disorders
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014