Improving Quality of Life for Veterans Undergoing Interferon Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00117559
First received: June 30, 2005
Last updated: December 9, 2014
Last verified: December 2014
  Purpose

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 Intervention
Depression
Hepatitis C
Behavioral: Telehealth Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Quality of Life for Veterans Undergoing Interferon Treatment

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • BDI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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).



Enrollment: 19
Study Start Date: July 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117559

Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: Amy Silberbogen, PhD VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00117559     History of Changes
Other Study ID Numbers: F3332-P
Study First Received: June 30, 2005
Results First Received: November 17, 2014
Last Updated: December 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Psychotherapy,group
Rehabilitation
Telecommunications

ClinicalTrials.gov processed this record on September 02, 2015