View Clinical Trial (Medical Research Study)
Psychoeducation for HCV and Alcohol Behaviors
| City: |
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St. Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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Hepatitis C - Substance Abuse |
| Purpose: |
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The proposed project will apply a unique, effective family-responsive psychoeducation
program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV)
treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of
some patients for HCV treatment and help sustain others through it.
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| Study Summary: |
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This study aims to evaluate the utility of a psychosocial intervention (PsychoEducation
Responsive to Families; PERF), applied to help patients prepare for and sustain HCV
treatment in the treatment setting. Through careful psychiatric diagnosis and multiple
longitudinal assessments, this study will also shed further light on the course of comorbid
alcohol use, drug use, and other psychiatric syndromes and their interrelationships. The
proposed study combines an innovative psychoeducation program with traditional HCV patient
care and education. The goal of this work is to improve treatment adherence, allowing
individual drug regimens to achieve their optimal effectiveness and reach a wider patient
population. Support and sustenance of patients from a psychosocial perspective while they
are in treatment should also help deliver more patients to sustained suppression of HCV as
well as help presently untreated patients and populations become candidates for this
therapy—ultimately reducing the disease burden of increasing numbers of patients needing
liver transplantation or facing imminent death.
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| Criteria: |
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Inclusion Criteria:
1. Individuals who are seropositive for HCV as determined by ELISA test and confirmed by
direct measure of viral load as part of their clinical care
2. Lack progressive or decompensated liver functions (manifest in jaundice, ascites,
variceal bleeding, hepatic encephalopathy)
3. Age at least 18 years
4. Identified family member(s)/significant other(s) also willing to participate in the
psychoeducation groups, and
5. Ability to provide informed consent for research participation. "Family" will be
defined to include biological relatives, as well as any non-biological individual or
significant other considered "family" by either the ill member or his/her immediate
family.
Exclusion Criteria:
1. Inability to provide informed consent such as irreversible cognitive impairment
precluding participation
2. Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal
bleeding, hepatic encephalopathy), and
3. Age <18 years.
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| NCT ID: |
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NCT00598416 |
| Primary Contact: |
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Principal Investigator
Carol S North, MD, MPE
Univeristy of Texas Southwestern Medical Center
Dana Downs, MA, MSW
Phone: 214-648-5378
Email: Dand.Downs@UTSouthwestern.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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St. Louis, Missouri 63110
United States
Lori Cupps
Phone: 314-286-1361
Email: cuppsl@psychiatry.wustl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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