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Improving Quality of Life for Veterans Undergoing Interferon Treatment

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ClinicalTrials.gov Identifier: NCT00117559
Recruitment Status : Completed
First Posted : July 7, 2005
Results First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

June 30, 2005
July 7, 2005
November 17, 2014
December 11, 2014
December 11, 2014
July 2005
June 2008   (Final data collection date for primary outcome measure)
BDI [ Time Frame: 8 weeks ]

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).

Scores on measures of adherence, quality of life and psychological functioning at 10 weeks and again three months following completion of treatment
Complete list of historical versions of study NCT00117559 on ClinicalTrials.gov Archive Site
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Improving Quality of Life for Veterans Undergoing Interferon Treatment
Improving Quality of Life for Veterans Undergoing Interferon Treatment
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Depression
  • Hepatitis C
Behavioral: Telehealth Treatment
Participants receive a 15-minute telephone call for 8 weeks
  • Experimental: TEL-CBT
    Telehealth, problem solving based treatment provided over the telephone
    Intervention: Behavioral: Telehealth Treatment
  • No Intervention: Treatment as Ususal
    Control group, no treatment provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
45
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00117559
F3332-P
No
Not Provided
Not Provided
VA Office of Research and Development ( US Department of Veterans Affairs )
US Department of Veterans Affairs
Not Provided
Principal Investigator: Amy Silberbogen, PhD VA Medical Center, Jamaica Plain Campus
VA Office of Research and Development
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP