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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

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.

Condition or disease Intervention/treatment Phase
Depression Hepatitis C Behavioral: Telehealth Treatment Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Quality of Life for Veterans Undergoing Interferon Treatment
Study Start Date : July 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: TEL-CBT
Telehealth, problem solving based treatment provided over the telephone
Behavioral: Telehealth Treatment
Participants receive a 15-minute telephone call for 8 weeks

No Intervention: Treatment as Ususal
Control group, no treatment provided



Primary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117559


Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Amy Silberbogen, PhD VA Medical Center, Jamaica Plain Campus

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00117559     History of Changes
Other Study ID Numbers: F3332-P
First Posted: July 7, 2005    Key Record Dates
Results First Posted: December 11, 2014
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by VA Office of Research and Development:
Psychotherapy,group
Rehabilitation
Telecommunications

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents