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OpenTrials
Completed

NCT Number: NCT00333710

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual Psychotherapy

Behavioral

Individual face-to-face contact with educational and goal setting components

Telehealth Intervention

Behavioral

Individual telephone contact with educational and goal setting components

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2006
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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