Hepatitis C, Mental Disorder, Substance Use Disorders
Conditions
Keywords
hepatitis C, mental disorder, substance use, psychosocial intervention
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.
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.
Interventions
BEHAVIORALpsychosocial intervention
motivational enhancing case management intervention
Sponsors
Roche Pharma AG
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed