Psychoeducation for Hepatitis and Alcohol Behaviors

Hepatitis C Clinical Trial

Official title:

Psychoeducation for HCV and Alcohol Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598416
• Other study ID #: NIAAA-NORTH-AA015201
• Secondary ID: R01AA015201
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: November 3, 2014
• Start date: September 2006
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Substance Abuse

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased treatment readiness and better treatment adherence for treatment of HCV.		Index, Post intervention, and 1 year follow-up	No
Secondary	Better management of substance abuse and other psychiatric disorders.		Index, Post intervention, and 1 year follow up	No
Secondary	Better social functioning and increased quality of life.		Index, Post intervention, and 1 year follow up	No