Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEL-CBT | Experimental | Telehealth, problem solving based treatment provided over the telephone |
|
| Treatment as Ususal | No Intervention | Control group, no treatment provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Treatment | Behavioral | Participants receive a 15-minute telephone call for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| BDI | 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). | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy Silberbogen, PhD | VA Medical Center, Jamaica Plain Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Jamaica Plain Campus | Boston | Massachusetts | 02130 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TEL-CBT | Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks |
| FG001 | Treatment as Usual | Control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TEL-CBT | Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks |
| BG001 | Treatment as Usual | Control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BDI | 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). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
During recruitment and when running subjects
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEL-CBT | Telehealth, problem solving based treatment Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks |
Not provided
Not provided
Small sample size, all male, no in-person comparison group, reporting bias in self-report measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Silberbogen, Ph.D. | VA Boston Healthcare System | 857-364-4797 | amy.silberbogen@va.gov |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BDI | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual | Control group |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Treatment as Ususal | Control group | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D007239 |
| Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |