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Open Access Study protocol

The Depression in Visual Impairment Trial (DEPVIT): trial design and protocol

Tom H Margrain1*, Claire Nollett1, Julia Shearn1, Miles Stanford3, Rhiannon Tudor Edwards4, Barbara Ryan1, Catey Bunce5, Robin Casten6, Mark T Hegel7 and Daniel J Smith2

Author Affiliations

1 School of Optometry and Vision Sciences, Cardiff University, Cardiff, CF24 4LU, UK

2 Institute of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, UK

3 Eye (Ophthalmology) team, South Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK

4 Centre for Economics and Policy in Health/Canolfan Economeg a Pholisi Iechyd IMSCaR, College of Health and Behavioural Sciences, Bangor University, Dean Street Building, Gwynedd, LL57 1UT, UK

5 Moorfields Eye Hospital, City Road, London, EC1V 2PD, UK

6 Department of Psychiatry and Human Behaviour, Jefferson Medical College, Philadelphia, USA

7 Department of Psychiatry, Dartmouth Medical School, Hanover, NH, USA

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BMC Psychiatry 2012, 12:57  doi:10.1186/1471-244X-12-57

Published: 6 June 2012

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, and recruitment rate estimation.

Discussion

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.

Trial registration

ISRCTN46824140