Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
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Purpose
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
| Condition | Intervention |
|---|---|
|
Chronic Disease Hepatitis C Stress Disorders, Post-Traumatic |
Behavioral: Individual psychotherapy Behavioral: Telehealth Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD |
- Measures of psychological status [ Time Frame: pre-treatment, post-treatment, 3 months, and 6-months ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | September 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Individual face-to-face contact
|
Behavioral: Individual psychotherapy
Individual face-to-face contact with educational and goal setting components
|
|
Experimental: 2
Individual telephone contact
|
Behavioral: Telehealth Intervention
Individual telephone contact with educational and goal setting components
|
|
No Intervention: 3
Control condition/treatment as usual
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| VA Medical Center, Jamaica Plain Campus | |
| Boston, Massachusetts, United States, 02130 | |
| Principal Investigator: | Amy Silberbogen, PhD | VA Medical Center, Jamaica Plain Campus |
More Information
No publications provided
| Responsible Party: | Silberbogen, Amy - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00333710 History of Changes |
| Other Study ID Numbers: | F4120V |
| Study First Received: | June 2, 2006 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Rehabilitation Telecommunication |
Additional relevant MeSH terms:
|
Chronic Disease Hepatitis Hepatitis A Hepatitis C Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Disease Attributes Pathologic Processes Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013