- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218556
Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
Preventing Depression in MMT Patients on Interferon
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently undergoing HCV treatment at RIH
- Enrolled in MMT for at least 6 months
Exclusion Criteria:
- Current major depressive episode
- Current suicidality
- Currently taking antidepressant medication
- Received HCV treatment in past
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Depression prevention
Cognitive behavioral treatment for depression.
|
Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
|
No Intervention: Control
Treatment as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
depression-related antiviral treatment failure
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan E Ramsey, Ph.D., Rhode Island Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Mood Disorders
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Depressive Disorder
- Hepatitis
- Hepatitis A
- Hepatitis C
- Depressive Disorder, Major
Other Study ID Numbers
- NIDA-16797-1
- R01-16797-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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