Chronic Disease, Hepatitis C, Stress Disorders, Post-Traumatic
Conditions
Keywords
Rehabilitation, Telecommunication
Brief summary
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
Detailed description
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
Interventions
BEHAVIORALIndividual psychotherapy
Individual face-to-face contact with educational and goal setting components
BEHAVIORALTelehealth Intervention
Individual telephone contact with educational and goal setting components
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of hepatitis C * Clinical diagnosis of posttraumatic stress disorder * Need to have access to a telephone
Exclusion criteria
* Life threatening or acute illness * Current alcohol or substance dependence * Currently prescribed interferon treatment * No access to a telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis C Virus Knowledge Questionnaire | pre-treatment, post-treatment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individual Face-to-face Contact Individual face-to-face contact treatment
Individual psychotherapy: Individual face-to-face contact with educational and goal setting components | 19 |
| Individual Telephone Contact Individual telephone contact treatment
Telehealth Intervention: Individual telephone contact with educational and goal setting components | 18 |
| Control Condition/Treatment as Usual Control condition/treatment as usual.
No active treatment | 16 |
| Total | 53 |
Baseline characteristics
| Characteristic | Individual Face-to-face Contact | Individual Telephone Contact | Control Condition/Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 54.37 years STANDARD_DEVIATION 4.89 | 52.28 years STANDARD_DEVIATION 5.19 | 55 years STANDARD_DEVIATION 6.8 | 53.85 years STANDARD_DEVIATION 5.64 |
| Region of Enrollment United States | 19 participants | 18 participants | 16 participants | 53 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 16 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 | 0 / 16 |
Outcome results
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
Time frame: pre-treatment, post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Face-to-face Contact | Hepatitis C Virus Knowledge Questionnaire | Pre-Treatment | 37.88 units on a scale | Standard Deviation 10.78 |
| Individual Face-to-face Contact | Hepatitis C Virus Knowledge Questionnaire | Post-Treatment | 45.38 units on a scale | Standard Deviation 7.89 |
| Individual Telephone Contact | Hepatitis C Virus Knowledge Questionnaire | Pre-Treatment | 40.50 units on a scale | Standard Deviation 6.19 |
| Individual Telephone Contact | Hepatitis C Virus Knowledge Questionnaire | Post-Treatment | 42.36 units on a scale | Standard Deviation 6.03 |
| Control Condition/Treatment as Usual | Hepatitis C Virus Knowledge Questionnaire | Pre-Treatment | 35.80 units on a scale | Standard Deviation 10.05 |
| Control Condition/Treatment as Usual | Hepatitis C Virus Knowledge Questionnaire | Post-Treatment | 34.73 units on a scale | Standard Deviation 11.09 |