Depression, Work Ability
Conditions
Brief summary
Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life. Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV. Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).
Interventions
DRUGSilybin 94 mg + vitamin E 90 mg + phospholipids 194 mg
DRUGsugar pill
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* HCV infection
Exclusion criteria
* cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work ability index | 12 months | Administration of questionnaire(Work ability Index - WAI)The work ability index is a tool to record the work ability of employees. It aims at identifying, at an early stage, health risks of early retirement an counteracting them. The questionnaire is aimed at: 1) the estimated current and future work ability; 2) diagnosed illness and the number of absenteeism days in the previous year; 3) the estimated sickness-related deterioration in the work performance; 4) mental ability reserves. The WAI evaluates current work ability compared with lifetime and in relation to the demands of the job, number of current diseases diagnosed by a physician, estimated work impairment due to diseases. |
Secondary
| Measure | Time frame |
|---|---|
| depression | 12 months |
Countries
Italy
Outcome results
None listed