Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117559
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2005-06-30
Brief Title:
Improving Quality of Life for Veterans Undergoing Interferon Treatment
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Quality of Life for Veterans Undergoing Interferon Treatment
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus It is hypothesized that the cognitive behavioral therapy CBT condition and the telehealth condition will result in significantly improved outcomes including enhanced adherence quality of life and psychological status
Detailed Description:
The purpose of the proposed pilot study is to evaluate a rehabilitative cognitive-behavioral group psychotherapy intervention and a telehealth intervention for veterans undergoing interferon treatment for the hepatitis C virus HCV The specific objectives of the proposed pilot study are 1 develop study methods and materials 2 evaluate study feasibility and 3 assess the efficacy of a cognitive-behavioral group therapy approach and a telehealth approach as compared to care as usual in a randomized design Participants will be 45 patients 15 participants in each condition from the VA Boston Healthcare System who are undergoing interferon treatment for HCV Assessment will occur at pre-treatment post-treatment and 3-month follow-up Assessments will measure key areas including adherence quality of life and psychological distress Analyses will examine study feasibility and the effects of the treatment condition It is hypothesized that the CBT condition and the telehealth condition will result in significantly improved outcomes including enhanced adherence quality of life and psychological status This treatment approach addresses initiatives by the National VHA Hepatitis C Program by optimizing the care of veterans experiencing the devastating side effects of interferon treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None