Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
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Purpose
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 | Intervention |
|---|---|
|
Hepatitis C Substance Use Disorders Mental Disorder |
Behavioral: psychosocial intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C |
- 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 ]
| Enrollment: | 101 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: SC
standard care
|
|
|
Experimental: INT
psychosocial intervention
|
Behavioral: psychosocial intervention
motivational enhancing case management intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, North Carolina | |
| Unversity of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Donna M Evon, PhD | University of North Carolina, Chapel Hill |
More Information
No publications provided
| 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 |
| Study First Received: | December 4, 2006 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
hepatitis C mental disorder substance use psychosocial intervention |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Hepatitis Hepatitis A Hepatitis C Substance-Related Disorders Schizophrenia and Disorders with Psychotic Features Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 19, 2013