Improving Quality of Life for Veterans Undergoing Interferon Treatment
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jul 2005
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedFirst Posted
Study publicly available on registry
July 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
December 11, 2014
CompletedDecember 11, 2014
December 1, 2014
2.9 years
June 30, 2005
November 17, 2014
December 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
8 weeks
Study Arms (2)
TEL-CBT
EXPERIMENTALTelehealth, problem solving based treatment provided over the telephone
Treatment as Ususal
NO INTERVENTIONControl group, no treatment provided
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of hepatitis C.
- Must be on the interferon treatment
- Need to have access to telephone.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small sample size, all male, no in-person comparison group, reporting bias in self-report measures.
Results Point of Contact
- Title
- Amy Silberbogen, Ph.D.
- Organization
- VA Boston Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Silberbogen, PhD
VA Medical Center, Jamaica Plain Campus
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 7, 2005
Study Start
July 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 11, 2014
Results First Posted
December 11, 2014
Record last verified: 2014-12