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Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

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ClinicalTrials.gov Identifier: NCT00407732
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : January 25, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Donna Evon, University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Substance Use Disorders Mental Disorder Behavioral: psychosocial intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
Study Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: SC
standard care
Experimental: INT
psychosocial intervention
Behavioral: psychosocial intervention
motivational enhancing case management intervention



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

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
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

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

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