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Improving Quality of Life for Veterans Undergoing Interferon Treatment

NCT ID: NCT00117559

Last Updated: 2014-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Depression Hepatitis C

Keywords

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Psychotherapy,group Rehabilitation Telecommunications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TEL-CBT

Telehealth, problem solving based treatment provided over the telephone

Group Type EXPERIMENTAL

Telehealth Treatment

Intervention Type BEHAVIORAL

Participants receive a 15-minute telephone call for 8 weeks

Treatment as Ususal

Control group, no treatment provided

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telehealth Treatment

Participants receive a 15-minute telephone call for 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Silberbogen, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Jamaica Plain Campus

Locations

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VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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F3332-P

Identifier Type: -

Identifier Source: org_study_id