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BMC Psychiatry
Published in: BMC Psychiatry 1/2017

Open Access 01-12-2017 | Study protocol

Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial

Authors: Btissame Massoudi, Marco H. Blanker, Evelien van Valen, Hans Wouters, Claudi L. H. Bockting, Huibert Burger

Published in: BMC Psychiatry | Issue 1/2017

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Abstract

Background

The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients’ own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment.

Methods

This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the ‘Act and Feel’ treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses.

Discussion

This trial will show whether blended care might be an appropriate treatment strategy for patients with depressive symptoms and depressive disorder in general practice.

Trial registration

Appendix
Available only for authorised users
Literature
1.
Kruijshaar ME, Barendregt J, Vos T, de Graaf R, Spijker J, Andrews G. Lifetime prevalence estimates of major depression: an indirect estimation method and a quantification of recall bias. Eur J Epidemiol. 2005;20(1):103–11.CrossRefPubMed
2.
3.
Wells KB, Stewart A, Hays RD, Burnam MA, Rogers W, Daniels M, et al. The functioning and well-being of depressed patients. Results from the medical outcomes study. JAMA. 1989;262(7):914–9.CrossRefPubMed
4.
Von Korff M, Ormel J, Katon W, Lin EH. Disability and depression among high utilizers of health care. A longitudinal analysis. Arch Gen Psychiatry. 1992;49(2):91–100.CrossRef
5.
Ustun TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJ. Global burden of depressive disorders in the year 2000. Br J Psychiatry. 2004;184:386–92.CrossRefPubMed
6.
Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, et al. Use of mental health services in Europe: results from the European study of the epidemiology of mental disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):47–54.
7.
Bijl RV, Ravelli A. Psychiatric morbidity, service use, and need for care in the general population: results of The Netherlands mental health survey and incidence study. Am J Public Health. 2000;90(4):602–7.CrossRefPubMedPubMedCentral
8.
Verhaak PF, Prins MA, Spreeuwenberg P, Draisma S, van Balkom TJ, Bensing JM, et al. Receiving treatment for common mental disorders. Gen Hosp Psychiatry. 2009;31(1):46–55.CrossRefPubMed
9.
Verhaak PF, van Dijk CE, Nuijen J, Verheij RA, Schellevis FG. Mental health care as delivered by Dutch general practitioners between 2004 and 2008. Scand J Prim Health Care. 2012;30(3):156–62.CrossRefPubMedPubMedCentral
10.
Wang PS, Berglund P, Kessler RC. Recent care of common mental disorders in the United States : prevalence and conformance with evidence-based recommendations. J Gen Intern Med. 2000;15(5):284–92.CrossRefPubMedPubMedCentral
11.
Kovess-Masfety V, Alonso J, Brugha TS, Angermeyer MC, Haro JM, Sevilla-Dedieu C, et al. Differences in lifetime use of services for mental health problems in six European countries. Psychiatr Serv. 2007;58(2):213–20.CrossRefPubMed
12.
Weel-Baumgarten V, van Gelderen MG, Grundmeijer HGLM, et al. NHG-Standaard Depressie (tweede herziening). Huisarts Wet. 2012;55(6):252–9.
13.
National Collaborating Centre for Mental Health (UK). Depression: the treatment and Management of Depression in adults (updated edition). 2010.
14.
Olfson M, Blanco C, Marcus SC. Treatment of adult depression in the United States. JAMA Intern Med. 2016;176(10):1482–91.CrossRefPubMed
15.
Bushnell J, McLeod D, Dowell A, Salmond C, Ramage S, Collings S, et al. The treatment of common mental health problems in general practice. Fam Pract. 2006;23(1):53–9.PubMed
16.
Sleath BL, Rubin RH, Huston SA. Antidepressant prescribing to Hispanic and non-Hispanic white patients in primary care. Ann Pharmacother. 2001;35(4):419–23.CrossRefPubMed
17.
Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–60.CrossRefPubMed
18.
Katon W, Schulberg H. Epidemiology of depression in primary care. Gen Hosp Psychiatry. 1992;14(4):237–47.CrossRefPubMed
19.
Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303(1):47–53.CrossRefPubMedPubMedCentral
20.
Bortolotti B, Menchetti M, Bellini F, Montaguti MB, Berardi D. Psychological interventions for major depression in primary care: a meta-analytic review of randomized controlled trials. Gen Hosp Psychiatry. 2008;30(4):293–302.CrossRefPubMed
21.
van Schaik DJ, Klijn AF, van Hout HP, van Marwijk HW, Beekman AT, de Haan M, et al. Patients' preferences in the treatment of depressive disorder in primary care. Gen Hosp Psychiatry. 2004;26(3):184–9.CrossRefPubMed
22.
Saltini A, David A, Trentini A, Marchi J, Pioli R. Clinical practice in mental health and educational needs in general practice. Recenti Prog Med. 2002;93(7–8):410–5.PubMed
23.
Hermens ML, Muntingh A, Franx G, van Splunteren PT, Nuyen JS, et al. BMC Fam Pract. 2014;15(5):2296-15-5.
24.
Mohr DC, Hart SL, Howard I, Julian L, Vella L, Catledge C, et al. Barriers to psychotherapy among depressed and nondepressed primary care patients. Ann Behav Med. 2006;32(3):254–8.CrossRefPubMed
25.
Alvidrez J, Azocar F. Distressed women's clinic patients: preferences for mental health treatments and perceived obstacles. Gen Hosp Psychiatry. 1999;21(5):340–7.CrossRefPubMed
26.
Barney LJ, Griffiths KM, Christensen H, Jorm AF. Exploring the nature of stigmatising beliefs about depression and help-seeking: implications for reducing stigma. BMC Public Health. 2009;9(61):2458-9-61.
27.
Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012;6;32(4):329–42.CrossRef
28.
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010;5(10):e13196.CrossRefPubMedPubMedCentral
29.
Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007;37(3):319–28.CrossRefPubMed
30.
van Ballegooijen W, Cuijpers P, van Straten A, Karyotaki E, Andersson G, Smit JH, et al. Adherence to internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis. PLoS One. 2014;9(7):e100674.CrossRefPubMedPubMedCentral
31.
Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014;13(3):288–95.CrossRefPubMedPubMedCentral
32.
Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, et al. Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms: a meta-analysis of individual participant data. JAMA Psychiatry. 2017;22
33.
Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One. 2010;5(6):e10939.CrossRefPubMedPubMedCentral
34.
Moreno FA, Chong J, Dumbauld J, Humke M, Byreddy S. Use of standard webcam and internet equipment for telepsychiatry treatment of depression among underserved Hispanics. Psychiatr Serv. 2012;63(12):1213–7.CrossRefPubMed
35.
Hilty DM, Marks S, Wegelin J, Callahan EJ, Nesbitt TS. A randomized, controlled trial of disease management modules, including telepsychiatric care, for depression in rural primary care. Psychiatry (Edgmont). 2007;4(2):58–65.
36.
Burton C, Szentagotai Tatar A, McKinstry B, Matheson C, Matu S, Moldovan R, et al. Pilot randomised controlled trial of Help4Mood, an embodied virtual agent-based system to support treatment of depression. J Telemed Telecare. 2016;22(6):348–55.CrossRefPubMed
37.
Hoifodt RS, Lillevoll KR, Griffiths KM, Wilsgaard T, Eisemann M, Waterloo K, et al. The clinical effectiveness of web-based cognitive behavioral therapy with face-to-face therapist support for depressed primary care patients: randomized controlled trial. J Med Internet Res. 2013;15(8):e153.CrossRefPubMedPubMedCentral
38.
Kivi M, Eriksson MC, Hange D, Petersson EL, Vernmark K, Johansson B, et al. Internet-based therapy for mild to moderate depression in Swedish primary care: short term results from the PRIM-NET randomized controlled trial. Cogn Behav Ther. 2014;43(4):289–98.CrossRefPubMedPubMedCentral
39.
Levesque DA, Van Marter DF, Schneider RJ, Bauer MR, Goldberg DN, Prochaska JO, et al. Randomized trial of a computer-tailored intervention for patients with depression. Am J Health Promot. 2011;26(2):77–89.CrossRefPubMed
40.
Simon GE, Ralston JD, Savarino J, Pabiniak C, Wentzel C, Operskalski BH. Randomized trial of depression follow-up care by online messaging. J Gen Intern Med. 2011;26(7):698–704.CrossRefPubMedPubMedCentral
41.
Salisbury C, O'Cathain A, Edwards L, Thomas C, Gaunt D, Hollinghurst S, et al. Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry. 2016;3(6):515–25.CrossRefPubMed
42.
Montero-Marin J, Araya R, Perez-Yus MC, Mayoral F, Gili M, Botella C, et al. An internet-based intervention for depression in primary Care in Spain: a randomized controlled trial. J Med Internet Res. 2016;18(8):e231.CrossRefPubMedPubMedCentral
43.
England E, Lester H. Implementing the role of the primary care mental health worker: a qualitative study. Br J Gen Pract. 2007;57(536):204–11.PubMedPubMedCentral
44.
Bower P. Primary care mental health workers: models of working and evidence of effectiveness. Br J Gen Pract. 2002;52(484):926–33.PubMedPubMedCentral
45.
Gilbody S, Littlewood E, Hewitt C, Brierley G, Tharmanathan P, Araya R, et al. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015;351:h5627.CrossRefPubMedPubMedCentral
46.
Hallgren M, Kraepelien M, Ojehagen A, Lindefors N, Zeebari Z, Kaldo V, et al. Physical exercise and internet-based cognitive-behavioural therapy in the treatment of depression: randomised controlled trial. Br J Psychiatry. 2015;207(3):227–34.CrossRefPubMed
47.
Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, et al. Therapist-delivered internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009;374(9690):628–34.CrossRefPubMed
48.
Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, et al. Cost and outcome of Behavioural activation versus cognitive Behavioural therapy for depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016;388(10047):871–80.CrossRefPubMedPubMedCentral
49.
Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011;198(1):66–72.CrossRefPubMed
50.
Littlewood E, Duarte A, Hewitt C, Knowles S, Palmer S, Walker S, et al. A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the randomised evaluation of the effectiveness and acceptability of computerised therapy (REEACT) trial. Health Technol Assess. 2015;viii(101):xxi-171.
51.
Hollinghurst S, Peters TJ, Kaur S, Wiles N, Lewis G, Kessler D. Cost-effectiveness of therapist-delivered online cognitive-behavioural therapy for depression: randomised controlled trial. Br J Psychiatry. 2010;197(4):297–304.CrossRefPubMed
52.
Simon GE, Revicki D, VonKorff M. Telephone assessment of depression severity. J Psychiatr Res. 1993;0;27(3):247–52.CrossRef
53.
Bockting CLH, van Valen E. Act and feel online: internet-based behavioral activation in Dutch. Treat Mod. 2015;
54.
Arjadi R, Nauta MH, Scholte WF, Hollon SD, Chowdhary N, Suryani AO, et al. Guided act and feel Indonesia (GAF-ID) - internet-based behavioral activation intervention for depression in Indonesia: study protocol for a randomized controlled trial. Trials. 2016;17(1):455,016-1577-9.CrossRef
55.
Lewinsohn PM. A behavioral approach to depression. In: Coyne JC, editor. Essential papers on depression. New York: New York University Press; 1985. p. 150–80.
56.
van Rijswijk E, Borghuis M, van de Lisdonk E, Zitman F, van Weel C. Treatment of mental health problems in general practice: a survey of psychotropics prescribed and other treatments provided. Int J Clin Pharmacol Ther. 2007;45(1):23–9.CrossRefPubMed
57.
Rijswijk van E. Mental health problems in general practice. UMC St Radboud: Nijmegen; 2005.
58.
Morriss R, Leese M, Chatwin J, Baldwin D, THREAD Study Group. Inter-rater reliability of the Hamilton depression rating scale as a diagnostic and outcome measure of depression in primary care. J Affect Disord. 2008;111(2–3):204–13.CrossRefPubMed
59.
Zimmerman M, Martinez JH, Young D, Chelminski I, Dalrymple K. Severity classification on the Hamilton depression rating scale. J Affect Disord. 2013;150(2):384–8.CrossRefPubMed
60.
Walker R. Understanding the Hamilton depression scores. 2012.
61.
Helmreich I, Wagner S, Mergl R, Allgaier AK, Hautzinger M, Henkel V, et al. Sensitivity to changes during antidepressant treatment: a comparison of unidimensional subscales of the inventory of depressive Symptomatology (IDS-C) and the Hamilton depression rating scale (HAMD) in patients with mild major, minor or subsyndromal depression. Eur Arch Psychiatry Clin Neurosci. 2012;262(4):291–304.CrossRefPubMed
62.
Brazier J, Connell J, Papaioannou D, Mukuria C, Mulhern B, Peasgood T, et al. A systematic review, psychometric analysis and qualitative assessment of generic preference-based measures of health in mental health populations and the estimation of mapping functions from widely used specific measures. Health Technol Assess. 2014;18(34):vii,viii, xiii-xxv):1–188.CrossRefPubMedPubMedCentral
63.
Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, et al. Validation of the "World Health Organization disability assessment schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010;8(51):7525-8-51.
64.
Grobbee DE, Hoes AW, Verheij TJ, Schrijvers AJ, van Ameijden EJ, Numans ME. The Utrecht health project: optimization of routine healthcare data for research. Eur J Epidemiol. 2005;20(3):285–7.CrossRefPubMed
65.
Wichers M, Peeters F, Geschwind N, Jacobs N, Simons CJ, Derom C, et al. Unveiling patterns of affective responses in daily life may improve outcome prediction in depression: a momentary assessment study. J Affect Disord. 2010;124(1–2):191–5.CrossRefPubMed
66.
Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13(217):6963-13-217.
67.
Handleiding Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P), Rotterdam. 2013. Available from: www.​imta.​nl.
68.
Hida E, Tango T. On the three-arm non-inferiority trial including a placebo with a prespecified margin. Stat Med. 2011;30(3):224–31.CrossRefPubMed
69.
Mynors-Wallis LM, Gath DH, Day A, Baker F. Randomised controlled trial of problem solving treatment, antidepressant medication, and combined treatment for major depression in primary care. BMJ. 2000;320(7226):26–30.CrossRefPubMedPubMedCentral
70.
71.
72.
Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007;60(12):1234–8.CrossRefPubMed
73.
Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol. 1992;45(7):769–73.CrossRefPubMed
74.
West M, Harrison J. Bayesian forecasting and dynamic models. second ed. Springer-Verlag New York: New York, NY, USA; 1999.
75.
Delespaul PAEG. Assessing schizophrenia in daily life : the experience sampling method. Maastricht: UPM, Universitary Press Maastricht, Maastricht; 1995.
76.
van Marwijk HW, Bijl D, Ader HJ, de Haan M. Antidepressant prescription for depression in general practice in The Netherlands. Pharm World Sci. 2001;23(2):46–9.CrossRefPubMed
77.
van Geffen EC, Gardarsdottir H, van Hulten R, van Dijk L, Egberts AC, Heerdink ER. Initiation of antidepressant therapy: do patients follow the GP's prescription? Br J Gen Pract. 2009;59(559):81–7.CrossRefPubMedPubMedCentral
78.
van Geffen EC, van Hulten R, Bouvy ML, Egberts AC, Heerdink ER. Characteristics and reasons associated with nonacceptance of selective serotonin-reuptake inhibitor treatment. Ann Pharmacother. 2008;42(2):218–25.CrossRefPubMed
79.
Moore M, Yuen HM, Dunn N, Mullee MA, Maskell J, Kendrick T. Explaining the rise in antidepressant prescribing: a descriptive study using the general practice research database. BMJ. 2009;339:b3999.CrossRefPubMedPubMedCentral
80.
Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012;32(4):329–42.CrossRefPubMed
81.
Ekers DM, Dawson MS, Bailey E. Dissemination of behavioural activation for depression to mental health nurses: training evaluation and benchmarked clinical outcomes. J Psychiatr Ment Health Nurs. 2013;20(2):186–92.CrossRefPubMed
82.
Bos FM, Schoevers RA, aan het Rot M. Experience sampling and ecological momentary assessment studies in psychopharmacology: a systematic review. Eur Neuropsychopharmacol. 2015;25(11):1853–64.CrossRefPubMed
Metadata
Title
Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial
Authors
Btissame Massoudi
Marco H. Blanker
Evelien van Valen
Hans Wouters
Claudi L. H. Bockting
Huibert Burger
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2017
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-017-1376-1

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