Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
|Depressive Disorder, Major Hepatitis C||Behavioral: Cognitive behavioral treatment for depression|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Preventing Depression in MMT Patients on Interferon|
- depression-related antiviral treatment failure [ Time Frame: 6 months ]
|Study Start Date:||January 2004|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Depression prevention
Cognitive behavioral treatment for depression.
Behavioral: Cognitive behavioral treatment for depression
Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
No Intervention: Control
Treatment as usual.
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|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|