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

December 4, 2006
January 24, 2012
January 2007
February 2010   (final data collection date for primary outcome measure)
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 ]
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
Complete list of historical versions of study NCT00407732 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Hepatitis C
  • Substance Use Disorders
  • Mental Disorder
Behavioral: psychosocial intervention
motivational enhancing case management intervention
  • No Intervention: SC
    standard care
  • Experimental: INT
    psychosocial intervention
    Intervention: Behavioral: psychosocial intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2011
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407732
05-2944 PEG228
No
Donna Evon, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Roche Pharma AG
Principal Investigator: Donna M Evon, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP