Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Donna Evon, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00407732
First received: December 4, 2006
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.


Condition Intervention
Hepatitis C
Substance Use Disorders
Mental Disorder
Behavioral: psychosocial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention. [ Time Frame: 3-, 6-, and 9-months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: January 2007
Study Completion Date: October 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: SC
standard care
Experimental: INT
psychosocial intervention
Behavioral: psychosocial intervention
motivational enhancing case management intervention

Detailed Description:

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Patients who have been deferred from therapy due to mental health or substance abuse issues will work with the team psychologist on following through with the hepatologist's treatment recommendations that would lead to becoming eligible for interferon therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has confirmed diagnosis of HCV;
  • Patient has expressed an interest in undergoing interferon treatment;
  • Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
  • Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
  • Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.

Exclusion Criteria:

  • Patient has a diagnosis of schizophrenia, psychosis;
  • Patient resides in a psychiatric residential facility;
  • Patient attempted suicide in the past five years;
  • Patient is a current intravenous drug user;
  • Patient is cognitively or decisionally-impaired due to brain disease or injury;
  • Patient has advanced liver disease that precludes them from interferon treatment;
  • Patient has other medical comorbidities that may exclude them from interferon treatment;
  • Patient does not want to pursue interferon treatment at the present time;
  • Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;
  • No access to telephone service;
  • Non-English speaking.
  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 ClinicalTrials.gov identifier: NCT00407732

Locations
United States, North Carolina
Unversity of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Roche Pharma AG
Investigators
Principal Investigator: Donna M Evon, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Donna Evon, Assistant Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00407732     History of Changes
Other Study ID Numbers: 05-2944 PEG228
Study First Received: December 4, 2006
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
hepatitis C
mental disorder
substance use
psychosocial intervention

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Hepatitis
Hepatitis A
Hepatitis C
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on July 31, 2014