Improving Quality of Life for Veterans Undergoing Interferon Treatment
Primary Purpose
Depression, Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Treatment
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Psychotherapy,group, Rehabilitation, Telecommunications
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of hepatitis C. Must be on the interferon treatment Need to have access to telephone. Exclusion Criteria: Life threatening or acute illness Current alcohol or substance abuse or dependence Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.
Sites / Locations
- VA Medical Center, Jamaica Plain Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TEL-CBT
Treatment as Ususal
Arm Description
Telehealth, problem solving based treatment provided over the telephone
Control group, no treatment provided
Outcomes
Primary Outcome Measures
BDI
Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression
The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach's alpha was high for the present sample at both time points (a = .91 and .90).
Secondary Outcome Measures
Full Information
NCT ID
NCT00117559
First Posted
June 30, 2005
Last Updated
December 9, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00117559
Brief Title
Improving Quality of Life for Veterans Undergoing Interferon Treatment
Official Title
Improving Quality of Life for Veterans Undergoing Interferon Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Hepatitis C
Keywords
Psychotherapy,group, Rehabilitation, Telecommunications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEL-CBT
Arm Type
Experimental
Arm Description
Telehealth, problem solving based treatment provided over the telephone
Arm Title
Treatment as Ususal
Arm Type
No Intervention
Arm Description
Control group, no treatment provided
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Treatment
Intervention Description
Participants receive a 15-minute telephone call for 8 weeks
Primary Outcome Measure Information:
Title
BDI
Description
Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression
The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is "I do not feel sad." The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach's alpha was high for the present sample at both time points (a = .91 and .90).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of hepatitis C.
Must be on the interferon treatment
Need to have access to telephone.
Exclusion Criteria:
Life threatening or acute illness
Current alcohol or substance abuse or dependence
Individuals already receiving psychological interventions specifically to manage the side effects of the IFN treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Silberbogen, PhD
Organizational Affiliation
VA Medical Center, Jamaica Plain Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Jamaica Plain Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Quality of Life for Veterans Undergoing Interferon Treatment
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