Clinical trial NCT00407732: Overcoming Psychiatric Barriers to the Treatment of Hepatitis C
Official title: Overcoming Neuropsychiatric Barriers to the Treatment of Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Substance Use Disorders
Mental Disorder
Keywords: hepatitis C
mental disorder
substance use
psychosocial intervention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2006-12-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Unversity of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna M Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References: