Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

NCT00407732 | Completed

• 1 other identifier: 05-2944 PEG228
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Substance Use Disorders; Mental Disorder

Keywords

hepatitis C; mental disorder; substance use; psychosocial intervention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SC

NO INTERVENTION

standard care

INT

EXPERIMENTAL

psychosocial intervention

Behavioral: psychosocial intervention

Interventions

psychosocial intervention BEHAVIORAL

motivational enhancing case management intervention

INT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Unversity of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders; Mental Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Donna M Evon, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: January 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)