Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C

Conditions
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Hepatitis C, Substance Use Disorders, Mental Disorder

Intervention / Treatment
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* Behavioral: psychosocial intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: SC<br>standard care | |
| Experimental: INT<br>psychosocial intervention | Behavioral: psychosocial intervention<br>* motivational enhancing case management intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C, mental disorder, substance use, psychosocial intervention