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| Sponsor: | The University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00407732 |
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: | Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
SC: No Intervention
standard care
|
|
|
INT: Experimental
psychosocial intervention
|
Behavioral: psychosocial intervention
motivational enhancing case management intervention
|
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:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Unversity of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Donna M Evon, PhD | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | University of North Carolina at Chapel Hill ( Donna M. Evon, PhD, Asst Professor of Medicine ) |
| Study ID Numbers: | 05-2944 PEG228 |
| Study First Received: | December 4, 2006 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00407732 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
hepatitis C mental disorder substance use psychosocial intervention |
|
Liver Diseases RNA Virus Infections Disease Flaviviridae Infections Hepatitis, Viral, Human Disorders of Environmental Origin Hepatitis |
Virus Diseases Pathologic Processes Digestive System Diseases Mental Disorders Substance-Related Disorders Hepatitis C |