Clinical trial NCT00333710: Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
Official title: Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Hepatitis C
Stress Disorders, Post-Traumatic
Keywords: Rehabilitation
Telecommunication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: Hepatitis C Virus Knowledge Questionnaire
timeFrame: pre-treatment, post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
Study officials:
affiliation: VA Medical Center, Jamaica Plain Campus
name: Amy Silberbogen, PhD
role: PRINCIPAL_INVESTIGATOR
References: