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

Primary Purpose

Depressive Disorder, Major, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral treatment for depression
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Disorder, Major focused on measuring Hepatitis C, Depressive Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Depression prevention

Control

Arm Description

Cognitive behavioral treatment for depression.

Treatment as usual.

Outcomes

Primary Outcome Measures

depression-related antiviral treatment failure

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00218556
Brief Title
Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1
Official Title
Preventing Depression in MMT Patients on Interferon
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Rhode Island Hospital

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Hepatitis C
Keywords
Hepatitis C, Depressive Symptoms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depression prevention
Arm Type
Experimental
Arm Description
Cognitive behavioral treatment for depression.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral treatment for depression
Intervention Description
Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C
Primary Outcome Measure Information:
Title
depression-related antiviral treatment failure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Ramsey, Ph.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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

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