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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00117559 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Improving Quality of Life for Veterans Undergoing Interferon Treatment |
| Estimated Enrollment: | 45 |
| 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 |
|---|---|
|
1: Experimental
Telehealth, problem solving based treatment
|
Behavioral: Telehealth Treatment
Participants receive a 15-minute telephone call for 8 weeks
|
|
2: No Intervention
Control group
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| VA Medical Center, Jamaica Plain Campus | |
| Boston, Massachusetts, United States, 02130 | |
| Principal Investigator: | Amy Silberbogen, PhD | VA Medical Center, Jamaica Plain Campus |
More Information
| Responsible Party: | Department of Veterans Affairs ( Silberbogen, Amy - Principal Investigator ) |
| Study ID Numbers: | F3332P |
| Study First Received: | June 30, 2005 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00117559 History of Changes |
| Health Authority: | United States: Federal Government |
|
Psychotherapy,group Rehabilitation Telecommunications |
|
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Depression Interferons |
Quality of Life Hepatitis, Viral, Human Hepatitis C Depressive Disorder Behavioral Symptoms |
|
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Depression Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C Behavioral Symptoms |
