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

This study has been completed.
Rhode Island Hospital
Information provided by (Responsible Party):
, Rhode Island Hospital Identifier:
First received: September 20, 2005
Last updated: January 11, 2017
Last verified: October 2015
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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00218556

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
Principal Investigator: Susan E Ramsey, Ph.D. Rhode Island Hospital
  More Information

Responsible Party: , Associate Professor (Research), Rhode Island Hospital Identifier: NCT00218556     History of Changes
Other Study ID Numbers: NIDA-16797-1
Study First Received: September 20, 2005
Last Updated: January 11, 2017

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

Additional relevant MeSH terms:
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 processed this record on September 21, 2017