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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00218556
First Posted: September 22, 2005
Last Update Posted: January 12, 2017
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.
Collaborator:
Rhode Island Hospital
Information provided by (Responsible Party):
, Rhode Island Hospital
  Purpose
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.

Condition Intervention
Depressive Disorder, Major Hepatitis C Behavioral: Cognitive behavioral treatment for depression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Depression in MMT Patients on Interferon

Resource links provided by NLM:


Further study details as provided by , Rhode Island Hospital:

Primary Outcome Measures:
  • depression-related antiviral treatment failure [ Time Frame: 6 months ]

Enrollment: 42
Study Start Date: January 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Rhode Island Hospital
Investigators
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital
  More Information

Responsible Party: , Associate Professor (Research), Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00218556     History of Changes
Other Study ID Numbers: NIDA-16797-1
R01-16797-1
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: January 12, 2017
Last Verified: October 2015

Keywords provided by , Rhode Island Hospital:
Hepatitis C, Depressive Symptoms

Additional relevant MeSH terms:
Depression
Hepatitis
Hepatitis A
Hepatitis C
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mood Disorders
Mental Disorders


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