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The main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. It is hypothesized that
Patients with comorbid diagnoses of HCV and PTSD may experience increased risk of diminished quality of life, given that PTSD is associated with poor self-care and medical non-compliance. To date, no systematic efforts to improve quality of life in this high-risk population have been documented. The main objective of this proposal is to develop and test the feasibility and efficacy of two cognitive-behavioral interventions (a telehealth intervention and a face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. A secondary objective is to evaluate the cost effectiveness of the interventions. I plan to develop the interventions, pilot test them, and deliver the refined treatments to veterans with HCV and PTSD. Participants will be 70 patients from VA Boston who meet study criteria. Assessment will occur at pre-treatment, post-treatment, and 3- and 6-month follow-up. Assessments will measure quality of life, self-care, motivation to engage in healthcare, and psychological distress. Analyses will examine study feasibility, the effects of the treatment conditions, and the cost effectiveness of the interventions. It is hypothesized that the telephone and face-to-face intervention will improve outcomes, as compared to treatment as usual, but that the participants will be more satisfied with the telephone intervention. In addition, it is predicted that the telephone condition will be cost effective as compared to the face-to-face intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual face-to-face contact | Experimental | Individual face-to-face contact treatment |
|
| Individual telephone contact | Experimental | Individual telephone contact treatment |
|
| Control condition/treatment as usual | No Intervention | Control condition/treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual psychotherapy | Behavioral | Individual face-to-face contact with educational and goal setting components |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis C Virus Knowledge Questionnaire | This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge | pre-treatment, post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Face-to-face Contact | Individual face-to-face contact treatment Individual psychotherapy: Individual face-to-face contact with educational and goal setting components |
| FG001 | Individual Telephone Contact | Individual telephone contact treatment Telehealth Intervention: Individual telephone contact with educational and goal setting components |
| FG002 | Control Condition/Treatment as Usual | Control condition/treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Face-to-face Contact | Individual face-to-face contact treatment Individual psychotherapy: Individual face-to-face contact with educational and goal setting components |
| BG001 | Individual Telephone Contact |
| 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 | Hepatitis C Virus Knowledge Questionnaire | This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge | Posted | Mean | Standard Deviation | units on a scale | pre-treatment, post-treatment |
|
During recruitment and when running subjects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Face-to-face Contact | Individual face-to-face contact treatment Individual psychotherapy: Individual face-to-face contact with educational and goal setting components |
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Small sample size, all male, reliance on self-report measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Silberbogen, Ph.D. | VA Boston Healthcare System | 857-364-4707 | amy.silberbogen@va.gov |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D006526 | Hepatitis C |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
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| Telehealth Intervention | Behavioral | Individual telephone contact with educational and goal setting components |
|
Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components
| BG002 | Control Condition/Treatment as Usual | Control condition/treatment as usual. No active treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control Condition/Treatment as Usual | Control condition/treatment as usual |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Individual Telephone Contact | Individual telephone contact treatment Telehealth Intervention: Individual telephone contact with educational and goal setting components | 0 | 18 | 0 | 18 |
| EG002 | Control Condition/Treatment as Usual | Control condition/treatment as usual | 0 | 16 | 0 | 16 |
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| D003141 | Communicable Diseases |
| 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 |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |