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Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

NCT ID: NCT00333710

Last Updated: 2014-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-10-31

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

Conditions

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Chronic Disease Hepatitis C Stress Disorders, Post-Traumatic

Keywords

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Rehabilitation Telecommunication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Individual face-to-face contact

Individual face-to-face contact treatment

Group Type EXPERIMENTAL

Individual psychotherapy

Intervention Type BEHAVIORAL

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

Individual telephone contact

Individual telephone contact treatment

Group Type EXPERIMENTAL

Telehealth Intervention

Intervention Type BEHAVIORAL

Individual telephone contact with educational and goal setting components

Control condition/treatment as usual

Control condition/treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individual psychotherapy

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

Intervention Type BEHAVIORAL

Telehealth Intervention

Individual telephone contact with educational and goal setting components

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Silberbogen, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Jamaica Plain Campus

Locations

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VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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F4120-V

Identifier Type: -

Identifier Source: org_study_id