Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00218556|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment|
|Depressive Disorder, Major Hepatitis C||Behavioral: Cognitive behavioral treatment for depression|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preventing Depression in MMT Patients on Interferon|
|Study Start Date :||January 2004|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
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.
- depression-related antiviral treatment failure [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218556
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Susan E Ramsey, Ph.D.||Rhode Island Hospital|