Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Psychoeducation for Hepatitis and Alcohol Behaviors

This study has been completed.
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier:
First received: January 10, 2008
Last updated: November 3, 2014
Last verified: November 2014

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:

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 ]

Enrollment: 556
Study Start Date: September 2006
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00598416

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Principal Investigator: Carol S North, MD, MPE Univeristy of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00598416     History of Changes
Other Study ID Numbers: NIAAA-NORTH-AA015201, R01-AA015201
Study First Received: January 10, 2008
Last Updated: November 3, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 20, 2014