NCT00218556

Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

Preventing Depression in MMT Patients on Interferon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

Detailed description

The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC). We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.

Conditions

• Depressive Disorder, Major
• Hepatitis C

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral treatment for depression	Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-09-22
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States