Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Conditions
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Chronic Disease, Hepatitis C, Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Individual psychotherapy
* Behavioral: Telehealth Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual face-to-face contact<br>Individual face-to-face contact treatment | Behavioral: Individual psychotherapy<br>* Individual face-to-face contact with educational and goal setting components<br>|
| Experimental: Individual telephone contact<br>Individual telephone contact treatment | Behavioral: Telehealth Intervention<br>* Individual telephone contact with educational and goal setting components<br>|
| No Intervention: Control condition/treatment as usual<br>Control condition/treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C Virus Knowledge Questionnaire | 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 | pre-treatment, post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Telecommunication