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Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 4, 2006
First Posted Date  ICMJE December 5, 2006
Last Update Posted Date January 25, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2006)
Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
Official Title  ICMJE Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE
  • Hepatitis C
  • Substance Use Disorders
  • Mental Disorder
Intervention  ICMJE Behavioral: psychosocial intervention
motivational enhancing case management intervention
Study Arms  ICMJE
  • No Intervention: SC
    standard care
  • Experimental: INT
    psychosocial intervention
    Intervention: Behavioral: psychosocial intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2012)
101
Original Enrollment  ICMJE
 (submitted: December 4, 2006)
100
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407732
Other Study ID Numbers  ICMJE 05-2944 PEG228
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Donna Evon, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Donna M Evon, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2012

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