the depression in visual impairment trial (depvit) trial design and protocol大萧条在视力损害试验(depvit)试验设计和协议.pdf

Margrain et al. BMC Psychiatry 2012, 12:57 /1471-244X/12/57 STUDY PROTOCOL Open Access The Depression in Visual Impairment Trial (DEPVIT): trial design and protocol 1* 1 1 3 4 1 Tom H Margrain , Claire Nollett , Julia Shearn , Miles Stanford , Rhiannon Tudor Edwards , Barbara Ryan , 5 6 7 2 Catey Bunce , Robin Casten , Mark T Hegel and Daniel J Smith Abstract Background: The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression. Methods /design: The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST), a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation) in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II) at 6 months. Secondary outcomes include change in depressive symptoms at 3 months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6 months, change in generic health related quality of life (EQ5D), the costs associated with PST, estimates of incremental cost effectiveness,