Clinical trial NCT00495768: Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
Official title: Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Depression
Keywords: Hepatitis C
HCV
Depression
Interferons
Ribavirin
Lead sponsor: South Texas Veterans Health Care System
Sponsor class: FED
First posted: 2007-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Two years
Secondary outcomes:
measure: 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.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: 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.
timeFrame: Two years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System, Audie Murphy Division
state: Texas
Study officials:
affiliation: South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio
name: Stephen L. Stern, M.D.
role: PRINCIPAL_INVESTIGATOR
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