Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00407732
Status:
COMPLETED
Last Update Posted:
2012-01-25
First Post:
2006-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2006-12-04', 'studyFirstSubmitQcDate': '2006-12-04', 'lastUpdatePostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether or not the patient is deemed an appropriate candidate for interferon therapy at the end of the 9-month intervention.', 'timeFrame': '3-, 6-, and 9-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C', 'mental disorder', 'substance use', 'psychosocial intervention'], 'conditions': ['Hepatitis C', 'Substance Use Disorders', 'Mental Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has confirmed diagnosis of HCV;\n* Patient has expressed an interest in undergoing interferon treatment;\n* Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;\n* Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;\n* Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.\n\nExclusion Criteria:\n\n* Patient has a diagnosis of schizophrenia, psychosis;\n* Patient resides in a psychiatric residential facility;\n* Patient attempted suicide in the past five years;\n* Patient is a current intravenous drug user;\n* Patient is cognitively or decisionally-impaired due to brain disease or injury;\n* Patient has advanced liver disease that precludes them from interferon treatment;\n* Patient has other medical comorbidities that may exclude them from interferon treatment;\n* Patient does not want to pursue interferon treatment at the present time;\n* Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;\n* No access to telephone service;\n* Non-English speaking.'}, 'identificationModule': {'nctId': 'NCT00407732', 'briefTitle': 'Overcoming Psychiatric Barriers to the Treatment of Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C', 'orgStudyIdInfo': {'id': '05-2944 PEG228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'SC', 'description': 'standard care'}, {'type': 'EXPERIMENTAL', 'label': 'INT', 'description': 'psychosocial intervention', 'interventionNames': ['Behavioral: psychosocial intervention']}], 'interventions': [{'name': 'psychosocial intervention', 'type': 'BEHAVIORAL', 'description': 'motivational enhancing case management intervention', 'armGroupLabels': ['INT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unversity of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Donna M Evon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Donna Evon', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}