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Psychoeducation for Hepatitis and Alcohol Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598416
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Substance Abuse Behavioral: Family-Responsive Psychoeducation Program (PERF) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychoeducation for HCV and Alcohol Behaviors
Study Start Date : September 2006
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Psychoeducation Behavioral: Family-Responsive Psychoeducation Program (PERF)
Group psychoeducation for HCV patients and their primary caregiver.

Primary Outcome Measures :
  1. Increased treatment readiness and better treatment adherence for treatment of HCV. [ Time Frame: Index, Post intervention, and 1 year follow-up ]

Secondary Outcome Measures :
  1. Better management of substance abuse and other psychiatric disorders. [ Time Frame: Index, Post intervention, and 1 year follow up ]
  2. Better social functioning and increased quality of life. [ Time Frame: Index, Post intervention, and 1 year follow up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598416

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Carol S North, MD, MPE Univeristy of Texas Southwestern Medical Center

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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00598416     History of Changes
Other Study ID Numbers: NIAAA-NORTH-AA015201
R01AA015201 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2008    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
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:
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Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis C
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs