CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 309 enrolled
Drug / intervention
Depression collaborative care modelother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01143896
NCT01143896N/ACompleted

Hepatitis C Translating Initiatives for Depression Into Solutions

VA Office of Research and Development·interventional·Posted Jun 14, 2010·Updated May 16, 2016

In Brief

A clinical study evaluating Depression collaborative care model for Hepatitis C and Depression. Completed, enrolled 309 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartFeb 1, 2012
Primary CompletionSep 1, 2014
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.1 years ago

Interventions

Depression collaborative care modelother

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.