The Depression in Visual Impairment Trial (DEPVIT): trial design and protocol.
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.
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, and recruitment rate estimation.


CONCLUSIONS
Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE's 'stepped care' approach to the treatment of depression in people with a visual impairment.


BACKGROUND
ISRCTN46824140.
Tom H
TH
Margrain
Claire
C
Nollett
Julia
J
Shearn
Miles
M
Stanford
Rhiannon Tudor
RT
Edwards
Barbara
B
Ryan
Catey
C
Bunce
Robin
R
Casten
Mark T
MT
Hegel
Daniel J
DJ
Smith
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003863:Depression / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D003866:Depressive Disorder / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D014786:Vision Disorders / Q000150:complications*; D055815:Young Adult