Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
Recruitment status was Recruiting
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.
Depressive Disorder, Major
Behavioral: Depressive Disorder, Major
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Preventing Depression in MMT Patients on Interferon|
- depression-related antiviral treatment failure
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218556
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Susan E Ramsey, Ph.D. 401-444-7831 firstname.lastname@example.org|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|