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Psychoeducation for Hepatitis and Alcohol Behaviors

This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), January 2008

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00598416
  Purpose

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.


Condition Intervention
Hepatitis C
Substance Abuse
Behavioral: Family-Responsive Psychoeducation Program (PERF)

MedlinePlus related topics:   Hepatitis    Hepatitis C   

ChemIDplus related topics:   Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:   Psychoeducation for HCV and Alcohol Behaviors

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Increased treatment readiness and better treatment adherence for treatment of HCV. [ Time Frame: Index, Post intervention, and 1 year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Better management of substance abuse and other psychiatric disorders. [ Time Frame: Index, Post intervention, and 1 year follow up ] [ Designated as safety issue: No ]
  • Better social functioning and increased quality of life. [ Time Frame: Index, Post intervention, and 1 year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:   400
Study Start Date:   September 2006
Estimated Study Completion Date:   August 2011
Estimated Primary Completion Date:   August 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Psychoeducation: Experimental Behavioral: Family-Responsive Psychoeducation Program (PERF)
Group psychoeducation for HCV patients and their primary caregiver.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598416

Contacts
Contact: Dana Downs, MA, MSW     214-648-5378     Dand.Downs@UTSouthwestern.edu    

Locations
United States, Missouri
Washington University School of Medicine     Recruiting
      St. Louis, Missouri, United States, 63110
      Contact: Lori Cupps     314-286-1361     cuppsl@psychiatry.wustl.edu    
      Principal Investigator: Barry Hong, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Carol S North, MD, MPE     Univeristy of Texas Southwestern Medical Center    
  More Information

Responsible Party:   University of Texas Southwestern Medical School ( Carol S. North, MD, MPE )
Study ID Numbers:   NIAAA-NORTH-AA015201, R01-AA015201
First Received:   January 10, 2008
Last Updated:   January 18, 2008
ClinicalTrials.gov Identifier:   NCT00598416
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Hepatitis C  
Substance Abuse  
Psychoeducation  
Psychiatric functioning  
Physical Functioning
Quality of Life
NIAAA
Alcohol

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Mental Disorders
Substance-Related Disorders
Quality of Life
Disorders of Environmental Origin
Hepatitis, Viral, Human
Hepatitis C
Ethanol

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 29, 2008




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