Improving Quality of Life for Veterans Undergoing Interferon Treatment

Not Applicable

Completed

• Conditions: Depression; Hepatitis C
• Interventions: Behavioral: Telehealth Treatment

• Registration Number: NCT00117559
• Lead Sponsor: US Department of Veterans Affairs

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-06-30
• Study Start: 2005-07
• Study First Submitted QC: 2005-07-06
• Study First Posted: 2005-07-07
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2014-11-17
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Results First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Clinical diagnosis of hepatitis C.
• Must be on the interferon treatment
• Need to have access to telephone.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEL-CBT	Telehealth Treatment	Telehealth, problem solving based treatment provided over the telephone

Primary Outcome Measures

Name	Time	Method
BDI	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).

Trial Locations

Locations (1)

VA Medical Center, Jamaica Plain Campus; 🇺🇸 Boston, Massachusetts, United States