Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Hepatitis C Clinical Trial

Official title:

Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333710
• Other study ID #: F4120-V
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: December 9, 2014
• Start date: September 2006
• Est. completion date: October 2009

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Individual psychotherapy
Individual face-to-face contact with educational and goal setting components
• Telehealth Intervention
Individual telephone contact with educational and goal setting components

Locations

Country	Name	City	State
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No