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Hepatitis C Translating Initiatives for Depression Into Effective Solutions

NCT01143896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2016-05-16

Study results available
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Summary

Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease progression and improves health related quality of life. However, \~70% of Veterans with CHC are considered ineligible for antiviral treatment. Most of these patients are excluded due to the presence of co-existing depression and substance use. The proposed project will adapt and adopt an evidence-based collaborative depression care model in CHC clinics. By removing the leading contraindication for antiviral treatment, this project will potentially yield benefits that go far beyond the obvious quality of life benefit from antidepressant therapy itself.

Conditions

Interventions

OTHER

Depression collaborative care model

The intervention will include a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Fasiha Kanwal, MBBS MD · Michael E. DeBakey VA Medical Center, Houston, TX

  • Jeffrey M. Pyne, MD · Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  • Brian Dieckgraefe, MD · St. Louis VA Medical Center John Cochran Division, St. Louis, MO

  • Matthew Goetz, MD · VA Greater Los Angeles Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-09-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143896 on ClinicalTrials.gov