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Hepatitis C Translating Initiatives for Depression Into Effective Solutions

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C; Depression

Intervention: Depression collaborative care model (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Fasiha Kanwal, MBBS MD, Principal Investigator, Affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
Jeffrey M. Pyne, MD, Principal Investigator, Affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Peter Anthony Brawer, PhD, Principal Investigator, Affiliation: St. Louis VA Medical Center John Cochran Division, St. Louis, MO


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.

Clinical Details

Official title: Hepatitis C Translating Initiatives for Depression Into Solutions

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Initiation of hepatitis C antiviral treatment and depression severity

Secondary outcome:

Quality of hepatitis C care

Medication adherence

Quality of depression care

Detailed description: Project Background and Rationale: Depression is highly prevalent, yet under-diagnosed and under-treated in CHC. Treatment models that increase collaborative management of depression by mental health and physical health clinicians can improve quality and outcomes, and collaborative care models have been identified as the best-practice for depression in VA primary care settings. However, the antiviral treatment for CHC patients may not benefit from the existing primary care-mental health integration because the antiviral treatment is time-limited and conducted in specialty clinics. Although there is little evidence evaluating the effects of collaborative depression care in specialty settings, QUERI HIV-hepatitis initiated one of the first such efforts that effectively implemented collaborative depression care in HIV clinics. Built on this experience, an intensive yet focused collaborative care model in CHC clinics may be effective in improving not only depression but also CHC care. This proposed study, "Hepatitis-Translating Initiatives for Depression into Effective Solutions (HEP-TIDES)" will target this issue. Project Objectives: The proposal has three overarching primary aims and one exploratory aim. The primary aims are (1) adapt and adopt the collaborative care model for improving depression care in specialty CHC care settings, (2) compare the effectiveness of HEP-TIDES to usual care in improving CHC care, and (3) compare the effectiveness of HEP-TIDES to usual care in improving depression care. The exploratory aim is to evaluate the cost-effectiveness of HEP-TIDES versus usual care. Project Methods: HEP-TIDES is a multi-site, multi-method implementation project. HEP-TIDES will use evidence-based quality improvement (EBQI) methods to adapt and implement depression screening and the collaborative care model for depression in the CHC clinics at 4 disparate VA facilities (aim 1). HEP-TIDES will involve CHC and mental health providers working with an off-site depression care team comprised of a depression care nurse manager, pharmacist, and a psychiatrist. The purpose of the team will be to support CHC and mental health clinicians in delivering evidence-based stepped-care depression treatment. The adapted model will also take into account the substance use disorders among CHC patients. HEP-TIDES implementation will be assessed using a formative evaluation of the implementation process and a summative evaluation of a randomized controlled implementation trial of collaborative depression care in 268 patients (aims 2 and 3).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- confirmed untreated infection (positive HCV RNA test)

- current PHQ-9 score of 10 or more

- current treatment in the CHC clinic

Exclusion Criteria:

- non-Veterans

- patients who do not have access to a telephone

- patients with current suicidal ideation

- patients with significant cognitive impairment as indicated by a score > 10 on the

Blessed Orientation Memory and Concentration Test

- patients with a chart diagnosis of schizophrenia

- patients with a chart diagnosis of bipolar disorder who have been hospitalized for a

mental health condition within the last 12 months

Locations and Contacts

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock, Little Rock, Arkansas 72205-5484, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California 90073, United States

St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis, Missouri 63106, United States

Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas 77030, United States

Additional Information

Starting date: February 2012
Last updated: May 8, 2015

Page last updated: August 20, 2015

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