Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Not Applicable

Completed

• Conditions: Chronic Disease; Hepatitis C; Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Individual psychotherapy; Behavioral: Telehealth Intervention

• Registration Number: NCT00333710
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Study Start: 2006-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2014-11-19
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Results First Posted: 2014-12-15
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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

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Exclusion Criteria

• Life threatening or acute illness
• Current alcohol or substance dependence
• Currently prescribed interferon treatment
• No access to a telephone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual face-to-face contact	Individual psychotherapy	Individual face-to-face contact treatment
Individual telephone contact	Telehealth Intervention	Individual telephone contact treatment

Primary Outcome Measures

Name	Time	Method
Hepatitis C Virus Knowledge Questionnaire	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

Trial Locations

Locations (1)

VA Medical Center, Jamaica Plain Campus; 🇺🇸 Boston, Massachusetts, United States