Skip to main content
Top
Published in: BMC Psychiatry 1/2012

Open Access 01-12-2012 | Study protocol

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

Authors: Tom H Margrain, Claire Nollett, Julia Shearn, Miles Stanford, Rhiannon Tudor Edwards, Barbara Ryan, Catey Bunce, Robin Casten, Mark T Hegel, Daniel J Smith

Published in: BMC Psychiatry | Issue 1/2012

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
go back to reference Osborn DPJ, Fletcher AE, Smeeth L, Stirling S, Bulpitt CJ, Breeze E, Ng ESW, Nunes M, Jones D, Tulloch A: Factors associated with depression in a representative sample of 14 217 people aged 75 and over in the United Kingdom: results from the MRC trial of assessment and management of older people in the community. Int J Geriatr Psychiatry. 2003, 18 (7): 623-630. 10.1002/gps.896.CrossRefPubMed Osborn DPJ, Fletcher AE, Smeeth L, Stirling S, Bulpitt CJ, Breeze E, Ng ESW, Nunes M, Jones D, Tulloch A: Factors associated with depression in a representative sample of 14 217 people aged 75 and over in the United Kingdom: results from the MRC trial of assessment and management of older people in the community. Int J Geriatr Psychiatry. 2003, 18 (7): 623-630. 10.1002/gps.896.CrossRefPubMed
2.
go back to reference Waern M, Rubenowitz E, Runeson B, Skoog I, Wilhelmson K, Allebeck P: Burden of illness and suicide in elderly people: case–control study. Br Med J. 2002, 324 (7350): 1355-1357. 10.1136/bmj.324.7350.1355.CrossRef Waern M, Rubenowitz E, Runeson B, Skoog I, Wilhelmson K, Allebeck P: Burden of illness and suicide in elderly people: case–control study. Br Med J. 2002, 324 (7350): 1355-1357. 10.1136/bmj.324.7350.1355.CrossRef
3.
go back to reference Evans JR, Fletcher AE, Wormald RPL: Depression and anxiety in visually impaired older people. Ophthalmology. 2007, 114 (2): 283-288. 10.1016/j.ophtha.2006.10.006.CrossRefPubMed Evans JR, Fletcher AE, Wormald RPL: Depression and anxiety in visually impaired older people. Ophthalmology. 2007, 114 (2): 283-288. 10.1016/j.ophtha.2006.10.006.CrossRefPubMed
4.
go back to reference Brody BL, Gamst AC, Williams RA, Smith AR, Lau PW, Dolnak D, Rapaport MH, Kaplan RM, Brown SI: Depression, visual acuity, comorbidity, and disability associated with age-related macular degeneration. Ophthalmology. 2001, 108 (10): 1893-1900. 10.1016/S0161-6420(01)00754-0.CrossRefPubMed Brody BL, Gamst AC, Williams RA, Smith AR, Lau PW, Dolnak D, Rapaport MH, Kaplan RM, Brown SI: Depression, visual acuity, comorbidity, and disability associated with age-related macular degeneration. Ophthalmology. 2001, 108 (10): 1893-1900. 10.1016/S0161-6420(01)00754-0.CrossRefPubMed
5.
go back to reference Brody BL, Roch-Levecq AC, Thomas RG, Kaplan RM, Brown SI: Self-management of age-related macular degeneration at the 6-month follow-up - A randomized controlled trial. Arch Ophthalmol. 2005, 123 (1): 46-53. 10.1001/archopht.123.1.46.CrossRefPubMed Brody BL, Roch-Levecq AC, Thomas RG, Kaplan RM, Brown SI: Self-management of age-related macular degeneration at the 6-month follow-up - A randomized controlled trial. Arch Ophthalmol. 2005, 123 (1): 46-53. 10.1001/archopht.123.1.46.CrossRefPubMed
6.
go back to reference Rovner BW, Casten RJ: Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001, 49 (8): 1097-1100. 10.1046/j.1532-5415.2001.49215.x.CrossRefPubMed Rovner BW, Casten RJ: Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001, 49 (8): 1097-1100. 10.1046/j.1532-5415.2001.49215.x.CrossRefPubMed
7.
go back to reference Rovner BW, ShmuelyDulitzki Y: Screening for depression in low-vision elderly. Int J Geriatr Psychiatry. 1997, 12 (9): 955-959. 10.1002/(SICI)1099-1166(199709)12:9<955::AID-GPS672>3.0.CO;2-5.CrossRefPubMed Rovner BW, ShmuelyDulitzki Y: Screening for depression in low-vision elderly. Int J Geriatr Psychiatry. 1997, 12 (9): 955-959. 10.1002/(SICI)1099-1166(199709)12:9<955::AID-GPS672>3.0.CO;2-5.CrossRefPubMed
8.
go back to reference Rovner BW, Casten RJ, Hegel MT, Leiby BE, Tasman WS: Preventing depression in age-related macular degeneration. Arch Gen Psychiatry. 2007, 64 (8): 886-892. 10.1001/archpsyc.64.8.886.CrossRefPubMed Rovner BW, Casten RJ, Hegel MT, Leiby BE, Tasman WS: Preventing depression in age-related macular degeneration. Arch Gen Psychiatry. 2007, 64 (8): 886-892. 10.1001/archpsyc.64.8.886.CrossRefPubMed
9.
go back to reference Margrain TH: Helping blind and partially sighted people to read: the effectiveness of low vision aids. Br J Ophthalmol. 2000, 84 (8): 919-921. 10.1136/bjo.84.8.919.CrossRefPubMedPubMedCentral Margrain TH: Helping blind and partially sighted people to read: the effectiveness of low vision aids. Br J Ophthalmol. 2000, 84 (8): 919-921. 10.1136/bjo.84.8.919.CrossRefPubMedPubMedCentral
10.
go back to reference Harper R, Doorduyn K, Reeves B, Slater L: Evaluating the outcomes of low vision rehabilitation. Ophthalmic Physiol Opt. 1999, 19 (1): 3-11. 10.1046/j.1475-1313.1999.00411.x.CrossRefPubMed Harper R, Doorduyn K, Reeves B, Slater L: Evaluating the outcomes of low vision rehabilitation. Ophthalmic Physiol Opt. 1999, 19 (1): 3-11. 10.1046/j.1475-1313.1999.00411.x.CrossRefPubMed
11.
go back to reference Scott IU, Smiddy WE, Schiffman J, Feuer WJ, Pappas CJ: Quality of life of low-vision patients and the impact of low-vision services. Am J Ophthalmol. 1999, 128 (1): 54-62. 10.1016/S0002-9394(99)00108-7.CrossRefPubMed Scott IU, Smiddy WE, Schiffman J, Feuer WJ, Pappas CJ: Quality of life of low-vision patients and the impact of low-vision services. Am J Ophthalmol. 1999, 128 (1): 54-62. 10.1016/S0002-9394(99)00108-7.CrossRefPubMed
12.
go back to reference Stelmack JA, Stelmack TR, Massof RW: Measuring low-vision rehabilitation outcomes with the NEI VFQ-25. Invest Ophthalmol Vis Sci. 2002, 43 (9): 2859-2868.PubMed Stelmack JA, Stelmack TR, Massof RW: Measuring low-vision rehabilitation outcomes with the NEI VFQ-25. Invest Ophthalmol Vis Sci. 2002, 43 (9): 2859-2868.PubMed
13.
go back to reference Horowitz A, Reinhardt JP, Boerner K: The effect of rehabilitation on depression among visually disabled older adults. Aging Ment Health. 2005, 9 (6): 563-570. 10.1080/13607860500193500.CrossRefPubMed Horowitz A, Reinhardt JP, Boerner K: The effect of rehabilitation on depression among visually disabled older adults. Aging Ment Health. 2005, 9 (6): 563-570. 10.1080/13607860500193500.CrossRefPubMed
14.
go back to reference Murray CJL, Lopez AD: Alternative projections of mortality and disability by cause 1990–2020: Global burden of disease study. Lancet. 1997, 349 (9064): 1498-1504. 10.1016/S0140-6736(96)07492-2.CrossRefPubMed Murray CJL, Lopez AD: Alternative projections of mortality and disability by cause 1990–2020: Global burden of disease study. Lancet. 1997, 349 (9064): 1498-1504. 10.1016/S0140-6736(96)07492-2.CrossRefPubMed
15.
go back to reference NICE: Depression in adults with a chronic physical health problem: Treatment and management. 2009, National Institute for Health and Clinical Excellence, London NICE: Depression in adults with a chronic physical health problem: Treatment and management. 2009, National Institute for Health and Clinical Excellence, London
16.
go back to reference Beck AT, Erbaugh J, Ward CH, Mock J, Mendelsohn M: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4 (6): 561-10.1001/archpsyc.1961.01710120031004.CrossRefPubMed Beck AT, Erbaugh J, Ward CH, Mock J, Mendelsohn M: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4 (6): 561-10.1001/archpsyc.1961.01710120031004.CrossRefPubMed
17.
go back to reference Beck AT, Steer RA, Garbin MG: Psychometric properties of the Beck Depression Inventory inventory - 25 years of evaluation. Clin Psychol Rev. 1988, 8 (1): 77-100. 10.1016/0272-7358(88)90050-5.CrossRef Beck AT, Steer RA, Garbin MG: Psychometric properties of the Beck Depression Inventory inventory - 25 years of evaluation. Clin Psychol Rev. 1988, 8 (1): 77-100. 10.1016/0272-7358(88)90050-5.CrossRef
18.
go back to reference Rabin R, de Charro F: EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001, 33 (5): 337-343. 10.3109/07853890109002087.CrossRefPubMed Rabin R, de Charro F: EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001, 33 (5): 337-343. 10.3109/07853890109002087.CrossRefPubMed
19.
go back to reference Ryan B, Court H, Margrain TH: Measuring low vision service outcomes: Rasch analysis of the seven-item National Eye Institute Visual Function Questionnaire. Optom Vis Sci. 2008, 85 (2): 112-121. 10.1097/OPX.0b013e31816225dc.CrossRefPubMed Ryan B, Court H, Margrain TH: Measuring low vision service outcomes: Rasch analysis of the seven-item National Eye Institute Visual Function Questionnaire. Optom Vis Sci. 2008, 85 (2): 112-121. 10.1097/OPX.0b013e31816225dc.CrossRefPubMed
20.
go back to reference Almeida OP, Almeida SA: Short versions of the geriatric depression scale: A study of their validity for the diagnosis of a major depressive episode according to ICD-10 and DSM-IV. Int J Geriatr Psychiatry. 1999, 14 (10): 858-865. 10.1002/(SICI)1099-1166(199910)14:10<858::AID-GPS35>3.0.CO;2-8.CrossRefPubMed Almeida OP, Almeida SA: Short versions of the geriatric depression scale: A study of their validity for the diagnosis of a major depressive episode according to ICD-10 and DSM-IV. Int J Geriatr Psychiatry. 1999, 14 (10): 858-865. 10.1002/(SICI)1099-1166(199910)14:10<858::AID-GPS35>3.0.CO;2-8.CrossRefPubMed
21.
go back to reference Chisholm D, Knapp MRJ, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B, Grp ES: Client Socio-Demographic and Service Receipt Inventory - European Version: Development of an instrument for international research - EPSILON Study 5. Br J Psychiatry. 2000, 177: S28-S33. 10.1192/bjp.177.39.s28.CrossRef Chisholm D, Knapp MRJ, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B, Grp ES: Client Socio-Demographic and Service Receipt Inventory - European Version: Development of an instrument for international research - EPSILON Study 5. Br J Psychiatry. 2000, 177: S28-S33. 10.1192/bjp.177.39.s28.CrossRef
22.
go back to reference Coast J, Peters TJ, Natarajan L, Sproston K, Flynn T: An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people. Qual Life Res. 2008, 17 (7): 967-976. 10.1007/s11136-008-9372-z.CrossRefPubMed Coast J, Peters TJ, Natarajan L, Sproston K, Flynn T: An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people. Qual Life Res. 2008, 17 (7): 967-976. 10.1007/s11136-008-9372-z.CrossRefPubMed
23.
24.
go back to reference Council MR: A framework for development and evaluation of RCT’s for complex interventions to improve health. 2008, Medical Research Council, London Council MR: A framework for development and evaluation of RCT’s for complex interventions to improve health. 2008, Medical Research Council, London
25.
go back to reference Edwards RT, Ceilleachair A, Bywater T, Hughes DA, Hutchings J: Parenting programme for parents of children at risk of developing conduct disorder: cost effectiveness analysis. Br Med J. 2007, 334 (7595): 682-685. 10.1136/bmj.39126.699421.55.CrossRef Edwards RT, Ceilleachair A, Bywater T, Hughes DA, Hutchings J: Parenting programme for parents of children at risk of developing conduct disorder: cost effectiveness analysis. Br Med J. 2007, 334 (7595): 682-685. 10.1136/bmj.39126.699421.55.CrossRef
26.
go back to reference Edwards RT, Hounsome B, Linck P, Russell IT: Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials. 2008, 9: 64-10.1186/1745-6215-9-64.CrossRefPubMedPubMedCentral Edwards RT, Hounsome B, Linck P, Russell IT: Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials. 2008, 9: 64-10.1186/1745-6215-9-64.CrossRefPubMedPubMedCentral
27.
go back to reference Fenwick E, O’Brien BJ, Briggs A: Cost-effectiveness acceptability curves - facts, fallacies and frequently asked questions. Health Econ. 2004, 13 (5): 405-415. 10.1002/hec.903.CrossRefPubMed Fenwick E, O’Brien BJ, Briggs A: Cost-effectiveness acceptability curves - facts, fallacies and frequently asked questions. Health Econ. 2004, 13 (5): 405-415. 10.1002/hec.903.CrossRefPubMed
28.
go back to reference Brazier JE, Yang Y, Tsuchiya A, Rowen DL: A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010, 11 (2): 215-225. 10.1007/s10198-009-0168-z.CrossRefPubMed Brazier JE, Yang Y, Tsuchiya A, Rowen DL: A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010, 11 (2): 215-225. 10.1007/s10198-009-0168-z.CrossRefPubMed
29.
go back to reference Culham LE, Ryan B, Jackson AJ, Hill AR, Jones B, Miles C, Young JA, Bunce C, Bird AC: Low vision services for vision rehabilitation in the United Kingdom. Br J Ophthalmol. 2002, 86 (7): 743-747. 10.1136/bjo.86.7.743.CrossRefPubMedPubMedCentral Culham LE, Ryan B, Jackson AJ, Hill AR, Jones B, Miles C, Young JA, Bunce C, Bird AC: Low vision services for vision rehabilitation in the United Kingdom. Br J Ophthalmol. 2002, 86 (7): 743-747. 10.1136/bjo.86.7.743.CrossRefPubMedPubMedCentral
30.
go back to reference Ryan B, White S, Wild J, Court H, Margrain TH: The newly established primary care based Welsh Low Vision Service is effective and has improved access to low vision services in Wales. Ophthalmic Physiol Opt. 2010, 30 (4): 358-364. 10.1111/j.1475-1313.2010.00729.x.CrossRefPubMed Ryan B, White S, Wild J, Court H, Margrain TH: The newly established primary care based Welsh Low Vision Service is effective and has improved access to low vision services in Wales. Ophthalmic Physiol Opt. 2010, 30 (4): 358-364. 10.1111/j.1475-1313.2010.00729.x.CrossRefPubMed
Metadata
Title
The Depression in Visual Impairment Trial (DEPVIT): trial design and protocol
Authors
Tom H Margrain
Claire Nollett
Julia Shearn
Miles Stanford
Rhiannon Tudor Edwards
Barbara Ryan
Catey Bunce
Robin Casten
Mark T Hegel
Daniel J Smith
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2012
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-12-57

Other articles of this Issue 1/2012

BMC Psychiatry 1/2012 Go to the issue