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

This study has been completed.
Rhode Island Hospital
Information provided by (Responsible Party):
Susan Ramsey, Rhode Island Hospital Identifier:
First received: September 20, 2005
Last updated: October 13, 2015
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • depression-related antiviral treatment failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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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: Susan Ramsey, Associate Professor (Research), Rhode Island Hospital Identifier: NCT00218556     History of Changes
Other Study ID Numbers: NIDA-16797-1  R01-16797-1 
Study First Received: September 20, 2005
Last Updated: October 13, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Hepatitis C, Depressive Symptoms

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Hepatitis A
Hepatitis C
Behavioral Symptoms
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
Mood Disorders
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on May 25, 2016