Depression, Hepatitis C
Conditions
Keywords
Psychotherapy,group, Rehabilitation, Telecommunications
Brief summary
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
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.
Interventions
BEHAVIORALTelehealth Treatment
Participants receive a 15-minute telephone call for 8 weeks
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BDI | 8 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TEL-CBT Telehealth, problem solving based treatment
Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks | 9 |
| Treatment as Usual Control group | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | TEL-CBT | Treatment as Usual | Total |
|---|---|---|---|
| Age, Continuous | 53.78 years STANDARD_DEVIATION 4.35 | 54.50 years STANDARD_DEVIATION 6.38 | 54.16 years STANDARD_DEVIATION 5.38 |
| BDI | 12.93 units on a scale STANDARD_DEVIATION 8.17 | 12.29 units on a scale STANDARD_DEVIATION 10.1 | 12.61 units on a scale STANDARD_DEVIATION 9.14 |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
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).
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEL-CBT | BDI | Pre-Treatment | 12.93 units on a scale | Standard Deviation 8.17 |
| TEL-CBT | BDI | Post-Treatment | 10.45 units on a scale | Standard Deviation 6.03 |
| Treatment as Usual | BDI | Pre-Treatment | 12.29 units on a scale | Standard Deviation 10.1 |
| Treatment as Usual | BDI | Post-Treatment | 16.67 units on a scale | Standard Deviation 9.8 |
p-value: <0.05ANOVA