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

BMC Psychiatry

Study Protocol

Rhiannon Tudor Edwards¹  Robin Casten²  Mark T Hegel³  Miles Stanford⁴  Daniel J Smith⁵  Catey Bunce⁶  Claire Nollett⁷  Tom H Margrain⁷  Barbara Ryan⁷  Julia Shearn⁷ 

[1] Centre for Economics and Policy in Health/Canolfan Economeg a Pholisi Iechyd IMSCaR, College of Health and Behavioural Sciences, Bangor University, Dean Street Building, LL57 1UT, Gwynedd, UK;Department of Psychiatry and Human Behaviour, Jefferson Medical College, Philadelphia, USA;Department of Psychiatry, Dartmouth Medical School, Hanover, NH, USA;Eye (Ophthalmology) team, South Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH, London, UK;Institute of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Gartnavel Royal Hospital, 1055 Great Western Road, G12 0XH, Glasgow, UK;Moorfields Eye Hospital, City Road, EC1V 2PD, London, UK;School of Optometry and Vision Sciences, Cardiff University, CF24 4LU, Cardiff, UK;

关键词: Depressive Symptom;    Visual Impairment;    Wait List Control;    Referral Letter;    Exploratory Trial;   

DOI  :  10.1186/1471-244X-12-57

 received in 2011-12-22, accepted in 2012-06-06,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundThe 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 /designThe 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.DiscussionDepression 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 registrationISRCTN46824140

【 授权许可】

CC BY   
© Margrain et al.; licensee BioMed Central Ltd. 2012