Psychoeducation for Hepatitis and Alcohol Behaviors

NCT ID: NCT00598416

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2013-08-31

Brief Summary

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.

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.

Conditions

Hepatitis C; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Psychoeducation

Group Type: EXPERIMENTAL

Family-Responsive Psychoeducation Program (PERF)

Intervention Type: BEHAVIORAL

Group psychoeducation for HCV patients and their primary caregiver.

Interventions

Family-Responsive Psychoeducation Program (PERF)

Group psychoeducation for HCV patients and their primary caregiver.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol S North, MD, MPE

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Texas Southwestern Medical Center

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

R01AA015201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAA-NORTH-AA015201

Identifier Type: -

Identifier Source: org_study_id