Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Psychiatry
Published in: BMC Psychiatry 1/2014

Open Access 01-12-2014 | Study protocol

Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial

Authors: Lisa C Kooistra, Jenneke E Wiersma, Jeroen Ruwaard, Patricia van Oppen, Filip Smit, Joran Lokkerbol, Pim Cuijpers, Heleen Riper

Published in: BMC Psychiatry | Issue 1/2014

Login to get access

Abstract

Background

Depression is a prevalent disorder, associated with a high disease burden and substantial societal, economic and personal costs. Cognitive behavioural treatment has been shown to provide adequate treatment for depression. By offering this treatment in a blended format, in which online and face-to-face treatment are combined, it might be possible to reduce the number of costly face-to-face sessions required to deliver the treatment protocol. This could improve the cost-effectiveness of treatment, while maintaining clinical effects. This protocol describes the design of a pilot study for the evaluation of the feasibility, acceptability and cost-effectiveness of blended cognitive behavioural therapy for patients with major depressive disorder in specialized outpatient mental health care.

Methods/design

In a randomized controlled trial design, adult patients with major depressive disorder are allocated to either blended cognitive behavioural treatment or traditional face-to-face cognitive behavioural treatment (treatment as usual). We aim to recruit one hundred and fifty patients. Blended treatment will consist of ten face-to-face and nine online sessions provided alternately on a weekly basis. Traditional cognitive behavioural treatment will consist of twenty weekly sessions. Costs and effects are measured at baseline and after 10, 20 and 30 weeks. Evaluations are directed at cost-effectiveness (with depression severity and diagnostic status as outcomes), and cost-utility (with costs per quality adjusted life year, QALY, as outcome). Costs will encompass health care uptake costs and productivity losses due to absence from work and lower levels of efficiency while at work. Other measures of interest are mastery, working alliance, treatment preference at baseline, depressive cognitions, treatment satisfaction and system usability.

Discussion

The results of this pilot study will provide an initial insight into the feasibility and acceptability of blended cognitive behavioural treatment in terms of clinical and economic outcomes (proof of concept) in routine specialized mental health care settings, and an indication as to whether a well-powered clinical trial of blended cognitive behavioural treatment for depression in routine practice would be advisable. This will be determined based on the perspective of various stakeholders including patients, mental health service providers and health insurers. Strengths and limitations of the study are discussed.

Trial registration

Netherlands Trial Register NTR4650. Registered 18 June 2014.
Appendix
Available only for authorised users
Literature
1.
Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE: Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005, 62: 617-627.CrossRefPubMedPubMedCentral
2.
3.
4.
Smit F, Cuijpers P, Oostenbrink J, Batelaan N, de Graaf R, Beekman A: Costs of nine common mental disorders: implications for curative and preventive psychiatry. J Ment Health Policy Econ. 2006, 9: 193-200.PubMed
5.
Cuijpers P, Smit F, Oostenbrink J, de Graaf R, Ten Have M, Beekman A: Economic costs of minor depression: a population-based study. Acta Psychiatr Scand. 2007, 115: 229-236.CrossRefPubMed
6.
Watkins KE, Burnam MA, Orlando M, Escarce JJ, Huskamp HA, Goldman HH: The health value and cost of care for major depression. Value Health. 2009, 12: 65-72.CrossRefPubMed
7.
Een Analyse van de Verwachte Kosten en Baten van eHealth, Blended Behandelen en Begeleiden - An Analysis of the Expected Costs and Benefits of eHealth, Blended Treatment and Guidance. 2013, GGZ Nederland, Amersfoort
8.
Kohn R, Saxena S, Levav I, Saraceno B: The treatment gap in mental health care. Bull World Health Organ. 2004, 82: 858-866.PubMedPubMedCentral
9.
Richards D, Richardson T: Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012, 32: 329-342.CrossRefPubMed
10.
Andersson G, Cuijpers P: Pros and cons of online cognitive-behavioural therapy. Br J Psychiatry. 2008, 193: 270-271.CrossRefPubMed
11.
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: e13196-CrossRefPubMedPubMedCentral
12.
Johansson R, Andersson G: Internet-based psychological treatments for depression. Expert Rev Neurother. 2012, 12: 861-870.CrossRefPubMed
13.
Andersson G, Cuijpers P: Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009, 38: 196-205.CrossRefPubMed
14.
Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E: Internet-based vs. face-to-face cognitive behaviour therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014, 13: 288-295.CrossRefPubMedPubMedCentral
15.
Warmerdam L, Smit F, van Straten A, Riper H, Cuijpers P: Cost-utility and cost-effectiveness of internet-based treatment for adults with depressive symptoms: randomized trial. J Med Internet Res. 2010, 12: e53-CrossRefPubMedPubMedCentral
16.
Lokkerbol J, Adema D, Cuijpers P, Reynolds CF, Schulz R, Weehuizen R, Smit F: Improving the cost-effectiveness of a healthcare system for depressive disorders by implementing telemedicine: a health economic modeling study. Am J Geriatr Psychiatry. 2014, 22: 253-262.CrossRefPubMed
17.
Gerhards SAH, de Graaf LE, Jacobs LE, Severens JL, Huibers MJH, Arntz A, Riper H, Widdershoven G, Metsemakers JFM, Evers SMAA: Economic evaluation of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry. 2010, 196: 310-318.CrossRefPubMed
18.
Smit F, Willemse G, Meulenbeek P, Koopmanschap M, van Balkom A, Spinhoven P, Cuijpers P: Preventing panic disorder: cost-effectiveness analysis alongside a pragmatic randomised trial. Cost Eff Resour Alloc. 2009, 7: 8-CrossRefPubMedPubMedCentral
19.
McCrone P: Cost-effectiveness of computerised cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004, 185: 55-62.CrossRefPubMed
20.
Riper H, van Ballegooijen W, Kooistra L, de Wit J, Donker T: Preventie & eMental-Health - Prevention & eMental-Health. 2013, Vrije Universiteit commissioned by ZonMw, Amsterdam
21.
Wilhelmsen M, Lillevoll K, Risør MB, Høifødt R, Johansen M-L, Waterloo K, Eisemann M, Kolstrup N: Motivation to persist with internet-based cognitive behavioural treatment using blended care: a qualitative study. BMC Psychiatry. 2013, 13: 296-304.CrossRefPubMedPubMedCentral
22.
Månsson KNT, Skagius Ruiz E, Gervind E, Dahlin M, Andersson G: Development and initial evaluation of an Internet-based support system for face-to-face cognitive behavior therapy: a proof of concept study. J Med Internet Res. 2013, 15: e280-CrossRefPubMedPubMedCentral
23.
Thompson SC, Schlehofer MM: The many sides of control motivation. Motives for high, low and illusory control. Handbook of Motivation Science. Edited by: Shah JY, Gardner WL. 2008, Guilford Press, New York, 41-56.
24.
Van der Zanden R, Galindo-Garre F, Curie K, Kramer J, Cuijpers P: Online cognitive-based intervention for depression: exploring possible circularity in mechanisms of change. Psychol Med. 2013, 44: 1159-1170.CrossRefPubMed
25.
Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, Sharp DJ, Araya R, Hollinghurst S, Peters TJ: Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009, 374: 628-634.CrossRefPubMed
26.
Hickie IB, Davenport TA, Luscombe GM, Moore M, Griffiths KM, Christensen H: Practitioner-supported delivery of internet-based cognitive behaviour therapy: evaluation of the feasibility of conducting a cluster randomised trial. Med J Aust. 2010, 192 (11 Suppl): S31-S35.PubMed
27.
Høifødt RS, Lillevoll KR, Griffiths KM, Wilsgaard T, Eisemann M, Waterloo K, Kolstrup N: 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: e153-CrossRefPubMedPubMedCentral
28.
Robertson L, Smith M, Castle D, Tannenbaum D: Using the Internet to enhance the treatment of depression. Australas Psychiatry. 2006, 14: 413-417.CrossRefPubMed
29.
Spijker J, Bockting CLH, Meeuwissen JAC, van Vliet IM, Emmelkamp PMG, Hermens MLM, van Balkom A: Multidisciplinaire Richtlijn Depressie (Derde Revisie). Richtlijn voor de Diagnostiek, Behandeling en Begeleiding van Volwassen patiënten met een depressieve stoornis -. 2013, Trimbos-instituut, Utrecht
30.
Butler AC, Chapman JE, Forman EM, Beck AT: The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006, 26: 17-31.CrossRefPubMed
31.
Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, Reed S: Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health. 2005, 8: 521-533.CrossRefPubMed
32.
Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P: Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices-budget impact analysis. Value Health. 2007, 10: 336-347.CrossRefPubMed
33.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E: Consolidated Health Economic Evaluation Reporting Standards (CHEERS)–explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013, 16: 231-250.CrossRefPubMed
34.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998, 59 (Suppl 2): 34-57.
35.
Van Vliet IM, De Beurs E: Het Mini Internationaal Neuropsychiatrisch Interview (MINI). Een kort gestructureerd diagnostisch psychiatrisch interview voor DSM-IV en ICD-10-stoornissen - The Mini International Neuropsychiatric Interview (MINI). A short structured diagnostic psychiatric interview for DSM-IV and ICS-10 disorders. Tijdschr Psychiatr. 2007, 49: 393-397.PubMed
36.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT: explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010, 2010 (63): e1-e37.CrossRef
37.
Moher D, Schulz KF, Altman D: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001, 285: 1987-1991.CrossRefPubMed
38.
Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011, 9: 672-677.CrossRefPubMed
39.
Bockting CLH, Huibers MJH: Protocollaire behandeling van patiënten met een depressieve stoornis - protocolled treatment of patients with a depressive disorder. Protocollaire Behandelingen voor Volwassenen met Psychische Klachten I - Protocolled treatments for patients with psychological complaints I. Edited by: Keijsers GPJ, Hoogduin CAL. 2011, Uitgeverij Boom, Amsterdam, 251-288.
40.
Rush AJ, Carmody T, Reimitz P: The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and Self-Report (IDS-SR) ratings of depressive symptoms. Int J Methods Psychiatr Res. 2000, 9: 45-59.CrossRef
41.
Cusin C, Yang H, Yeung A, Fava M: Rating scales for depression. Handbook of Clinical Rating Scales and Assessment in Psychiatry and Mental Health. Edited by: Baer L, Blais MA. 2010, Humana Press, Totowa, NJ, 7-35.
42.
Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH: The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996, 26: 477-486.CrossRefPubMed
43.
Trivedi MH, Rush AJ, Ibrahim HM, Carmody TJ, Biggs MM, Suppes T, Crismon ML, Shores-Wilson K, Toprac MG, Dennehy EB, Witte B, Kashner TM: The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med. 2004, 34: 73-82.CrossRefPubMed
44.
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB: The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003, 54: 573-583.CrossRefPubMed
45.
Group EQ: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16: 199-208.CrossRef
46.
Lamers LM, McDonnell J, Stalmeier PFM, Krabbe PFM, Busschbach JJV: The Dutch tariff: results and arguments for an effective design for national EQ-5D valuation studies. Health Econ. 2006, 15: 1121-1132.CrossRefPubMed
47.
Drummond M, Sculpher M: Common methodological flaws in economic evaluations. Med Care. 2005, 43 (7 Suppl): 5-14.PubMed
48.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart G: Cost Methods for the Economic Evaluation of Health Care Programmes. 2005, Oxford University Press, Oxford
49.
Aaronson NK, Muller M, Cohen PDA, Essink-Bot M-L, Fekkes M, Sanderman R, Sprangers MAG, te Velde A, Verrips E: Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998, 51: 1055-1068.CrossRefPubMed
50.
Bech P, Olsen LR, Kjoller M, Rasmussen NK: Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res. 2003, 12: 85-91.CrossRefPubMed
51.
Ware JEJ, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey: Manual and Interpretation Guide. 1993, New England Medical Center, Health Institute, Boston
52.
53.
Brazier J, Roberts J, Deverill M: The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002, 21: 271-292.CrossRefPubMed
54.
Hakkaart-van Roijen L, van Straten A, Tiemens B, Donker MCH: Manual Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (TiC-P). 2002, Institute of Medical Technology Assessment (iMTA) Erasmus University Rotterdam, Rotterdam
55.
Tan S, Bouwmans-Frijters CAM, Roijen L: Handleiding voor kostenonderzoek: methoden en referentieprijzen voor economische evaluaties in de gezondheidszorg - Manual for cost research: methods and reference prices for economic evaluations in health care. Tijdschr voor gezondheidswetenschappen. 2012, 90: 367-372.CrossRef
56.
57.
Hatcher RL, Gillaspy JA: Development and validation of a revised short version of the working alliance inventory. Psychother Res. 2006, 16: 12-25.CrossRef
58.
Stinckens N, Ulburghs A, Claes L: De werkalliantie als sleutelelement in het therapiegebeuren: Meting met behulp van de WAV-12, de Nederlandstalige versie van de Working Alliance Inventory - The working alliance as a key element in therapy: Measurement using the WAV-12, the Dutch shortened version of the Working Alliance Inventory. Tijdschr voor Klin Psychol. 2009, 39: 44-60.
59.
Beck AT, Brown G, Steer RA, Eidelson JI, Riskind JH: Differentiating anxiety and depression: a test of the cognitive content-specificity hypothesis. J Abnorm Psychol. 1987, 96: 179-183.CrossRefPubMed
60.
Steer RA, Beck AT, Clark DA, Beck JS: Psychometric properties of the Cognition Checklist with psychiatric outpatients and university students. Psychol Assess. 1994, 6: 67-70.CrossRef
61.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD: Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979, 2: 197-207.CrossRefPubMed
62.
De Brey H: A cross-national validation of the Client Satisfaction Questionnaire: the Dutch experience. Eval Program Plann. 1983, 6: 395-400.CrossRefPubMed
63.
Brooke J: SUS: a "quick and dirty" usability scale. Usability Evaluation in Industry. Edited by: Jordan PW, Thomas B, Weerdmeester BA, McClelland IL. 1996, Taylor & Francis Ltd, London, 189-194.
64.
Bangor A, Kortum PT, Miller JT: An empirical evaluation of the System Usability Scale. Int J Hum Comput Interact. 2008, 24: 574-594.CrossRef
65.
Bijl RV, van Zessen G, Ravelli A, de Rijk C, Langendoen Y: The Netherlands Mental Health Survey and Incidence Study (NEMESIS): objectives and design. Soc Psychiatry Psychiatr Epidemiol. 1998, 33: 581-586.CrossRefPubMed
66.
Briggs AH, Claxton K, Sculpher MJ: Decision Modelling for Health Economic Evaluation. 2006, Oxford University Press, Oxford
67.
Bosmans JE, de Bruijne MC, van Hout HPJ, Hermens MLM, Adèr HJ, van Tulder MW: Practical guidelines for economic evaluations alongside equivalence trials. Value Health. 2008, 11: 251-258.CrossRefPubMed
68.
Cohen J: Statistical Power Analysis for the Behavioral Sciences (revised Edition). 1988, Lawrence Erlbaum Associates, Inc, Hillsdale, NJ
69.
Cuijpers P, Huibers M, Ebert DD, Koole SL, Andersson G: How much psychotherapy is needed to treat depression? A metaregression analysis. J Affect Disord. 2013, 149: 1-13.CrossRefPubMed
Metadata
Title
Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial
Authors
Lisa C Kooistra
Jenneke E Wiersma
Jeroen Ruwaard
Patricia van Oppen
Filip Smit
Joran Lokkerbol
Pim Cuijpers
Heleen Riper
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2014
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-014-0290-z

Other articles of this Issue 1/2014

BMC Psychiatry 1/2014 Go to the issue

Study protocol

Protocol for a proof of concept randomized controlled trial of cognitive-behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone

Research article

Depression and the risk of coronary heart disease: a meta-analysis of prospective cohort studies

Research article

Social class and gender patterning of insomnia symptoms and psychiatric distress: a 20-year prospective cohort study

Research article

The association of ADHD symptoms to self-harm behaviours: a systematic PRISMA review

Research article

How do psychiatrists address delusions in first meetings in acute care? A qualitative study

Research article

Improving communication and practical skills in working with inpatients who self-harm: a pre-test/post-test study of the effects of a training programme