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Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Mental Disorder
Hepatitis C
Substance Use Disorders

Treatments

Behavioral: psychosocial intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00407732
05-2944 PEG228

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

101 participants in 2 patient groups

SC
No Intervention group
Description:
standard care
INT
Experimental group
Description:
psychosocial intervention
Treatment:
Behavioral: psychosocial intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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