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Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333710
First Posted: June 6, 2006
Last Update Posted: December 15, 2014
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.
Information provided by (Responsible Party):
VA Office of Research and Development
June 2, 2006
June 6, 2006
November 19, 2014
December 15, 2014
December 15, 2014
September 2006
October 2009   (Final data collection date for primary outcome measure)
Hepatitis C Virus Knowledge Questionnaire [ Time Frame: pre-treatment, post-treatment ]
This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge
Scores on measures of quality of life, self-care, motivation to engage in healthcare and psychological distress at post-treatment and again three and six months following the completion of treatment
Complete list of historical versions of study NCT00333710 on ClinicalTrials.gov Archive Site
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Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
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
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
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
  • Chronic Disease
  • Hepatitis C
  • Stress Disorders, Post-Traumatic
  • Behavioral: Individual psychotherapy
    Individual face-to-face contact with educational and goal setting components
  • Behavioral: Telehealth Intervention
    Individual telephone contact with educational and goal setting components
  • Experimental: Individual face-to-face contact
    Individual face-to-face contact treatment
    Intervention: Behavioral: Individual psychotherapy
  • Experimental: Individual telephone contact
    Individual telephone contact treatment
    Intervention: Behavioral: Telehealth Intervention
  • No Intervention: Control condition/treatment as usual
    Control condition/treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
October 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00333710
F4120-V
No
Not Provided
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Amy Silberbogen, PhD VA Medical Center, Jamaica Plain Campus
VA Office of Research and Development
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP