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Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333710
First received: June 2, 2006
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. It is hypothesized that


Condition Intervention
Chronic Disease
Hepatitis C
Stress Disorders, Post-Traumatic
Behavioral: Individual psychotherapy
Behavioral: Telehealth Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Measures of psychological status [ Time Frame: pre-treatment, post-treatment, 3 months, and 6-months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Individual face-to-face contact
Behavioral: Individual psychotherapy
Individual face-to-face contact with educational and goal setting components
Experimental: Arm 2
Individual telephone contact
Behavioral: Telehealth Intervention
Individual telephone contact with educational and goal setting components
No Intervention: Arm 3
Control condition/treatment as usual

Detailed Description:

Patients with comorbid diagnoses of HCV and PTSD may experience increased risk of diminished quality of life, given that PTSD is associated with poor self-care and medical non-compliance. To date, no systematic efforts to improve quality of life in this high-risk population have been documented. The main objective of this proposal is to develop and test the feasibility and efficacy of two cognitive-behavioral interventions (a telehealth intervention and a face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. A secondary objective is to evaluate the cost effectiveness of the interventions. I plan to develop the interventions, pilot test them, and deliver the refined treatments to veterans with HCV and PTSD. Participants will be 70 patients from VA Boston who meet study criteria. Assessment will occur at pre-treatment, post-treatment, and 3- and 6-month follow-up. Assessments will measure quality of life, self-care, motivation to engage in healthcare, and psychological distress. Analyses will examine study feasibility, the effects of the treatment conditions, and the cost effectiveness of the interventions. It is hypothesized that the telephone and face-to-face intervention will improve outcomes, as compared to treatment as usual, but that the participants will be more satisfied with the telephone intervention. In addition, it is predicted that the telephone condition will be cost effective as compared to the face-to-face intervention

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of hepatitis C
  • Clinical diagnosis of posttraumatic stress disorder
  • Need to have access to a telephone

Exclusion Criteria:

  • Life threatening or acute illness
  • Current alcohol or substance dependence
  • Currently prescribed interferon treatment
  • No access to a telephone
  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 ClinicalTrials.gov identifier: NCT00333710

Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: Amy Silberbogen, PhD VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00333710     History of Changes
Other Study ID Numbers: F4120-V
Study First Received: June 2, 2006
Last Updated: September 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Rehabilitation
Telecommunication

Additional relevant MeSH terms:
Chronic Disease
Hepatitis
Hepatitis A
Hepatitis C
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Digestive System Diseases
Disease Attributes
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014