Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

Hepatitis C Clinical Trial

Official title:

Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407732
• Other study ID #: 05-2944 PEG228
• Status: Completed
• Phase: N/A
• First received: December 4, 2006
• Last updated: January 24, 2012
• Start date: January 2007
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Mental Disorder
• Mental Disorders
• Psychotic Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• psychosocial intervention
motivational enhancing case management intervention

Locations

Country	Name	City	State
United States	Unversity of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.		3-, 6-, and 9-months	No