Psychoeducation for Hepatitis and Alcohol Behaviors - Full Text View

Sponsor:	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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Psychoeducation for HCV and Alcohol Behaviors

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ethanol

U.S. FDA Resources

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
Experimental: Psychoeducation	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:

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
Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy)
Age at least 18 years
Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and
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:

Inability to provide informed consent such as irreversible cognitive impairment precluding participation
Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and
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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Carol S North, MD, MPE

Univeristy of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Carol S. North, MD, MPE, University of Texas Southwestern Medical School
ClinicalTrials.gov Identifier:	NCT00598416 History of Changes
Other Study ID Numbers:	NIAAA-NORTH-AA015201, R01-AA015201
Study First Received:	January 10, 2008
Last Updated:	November 20, 2009
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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012