Top

Published in:

Open Access 01-12-2013 | Study protocol

Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study

Authors: Yolanda López-del-Hoyo, Barbara Olivan, Juan V Luciano, Fermín Mayoral, Miquel Roca, Margalida Gili, Eva Andres, Antoni Serrano-Blanco, Francisco Collazo, Ricardo Araya, Rosa Baños, Cristina Botella, Rosa Magallón, Javier García-Campayo

Published in: BMC Psychiatry | Issue 1/2013

Abstract

Background

Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.

Methods

The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.

Discussion

The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting.

Trial registration

Clinical Trials NCT01611818

Available only for authorised users

Fernández A, Pinto-Meza A, Bellón JA, Luciano JV, Autonell J, Palao D, Salvador-Carulla L, García Campayo J, Haro JM, Serrano-Blanco A, DASMAP investigators: Burden of chronic physical conditions and mental disorders in the Catalan Primary Care. Results from the DASMAP study. Brit J Psychiat. 2010, 196: 302-309. 10.1192/bjp.bp.109.074211.CrossRefPubMed

Sartorius N, Goldberg D, Girolamo G, Silva JA Ce, Lecrubier Y, Wittchen HU: Psychological disorders in general medical settings. 1990, New York: Hogrefe&Huber Publishers

World Health Organization: The global burden of disease. 2001, Géneve: WHO

Goldberg DP, Huxley P: Common mental disorders: A bio-social model. 1992, London: Routledge

Serrano-Blanco A, Palao DJ, Luciano JV, Pinto-Meza A, Luján L, Fernández A, Roura P, Bertsch J, Mercader M, Haro JM: Prevalence of mental disorders in primary care: results from the Catalan ‘Diagnosis and Treatment of Mental Disorders in Primary Care Study. Soc Psychiatry Psychiatr Epidemiol. 2010, 45: 201-210. 10.1007/s00127-009-0056-y.CrossRefPubMed

Van Schaik D, Klijn A, van Hout H: Patients preferences in the treatment of depressive disorders in primary care. Gen Hosp Psychiatry. 2004, 26: 184-189. 10.1016/j.genhosppsych.2003.12.001.CrossRefPubMed

Cuijpers P, van Straten A, van Oppen P, Andersson G: Are psychological and pharmacologic interventions equally effective in the treatment of adult depressive disorders? A meta-analysis of comparative studies. J Clin Psychiatry. 2008, 69: 1675-1685. 10.4088/JCP.v69n1102.CrossRefPubMed

Andrews G, Issakidis C, Sanderson K: Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004, 184: 526-533. 10.1192/bjp.184.6.526.CrossRefPubMed

Lehtinen V, Riikonen E, Latineen E: Promotion of Mental Health on the European Agenda. Report. 2000, Finnish Ministry of Social Affairs and Health: Department for Prevention and Promotion

10.

Kaltenthaler E, Parry G, Beverley C, Ferriter M: Computerized cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008, 193: 181-184. 10.1192/bjp.bp.106.025981.CrossRefPubMed

11.

Marks IM, Cavanagh K, Gega L: Computer-aided psychotherapy: revolution or bubble?. Br J Psychiatry. 2007, 191: 471-473. 10.1192/bjp.bp.107.041152.CrossRefPubMed

12.

Marks I, Cavanagh K: Computer-aided psychological treatments: evolving issues. Annu Rev Clin Psychol. 2009, 5: 121-141. 10.1146/annurev.clinpsy.032408.153538.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. 10.1080/16506070903318960.CrossRefPubMed

14.

Cuijpers P, Mark IM, van Straten A: Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther. 2009, 38: 66-82. 10.1080/16506070802694776.CrossRefPubMed

15.

Titov N: Status of computerized cognitive behavioural therapy for adults. Aust N Z J Psychiatry. 2007, 41: 95-114. 10.1080/00048670601109873.CrossRefPubMed

16.

Bender JL, Radhakrishnan A, Diorio C, Englesakis M: Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011, 152: 1740-1750. 10.1016/j.pain.2011.02.012.CrossRefPubMed

17.

McCrone P, Knapp M, Proudfoot J, Ryden C, Cavanagh K, Shapiro DA, Ilson S: Cost-effectiveness of computerized cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004, 185: 55-62. 10.1192/bjp.185.1.55.CrossRefPubMed

18.

McCrone P, Marks IM, Mataix-Cols D, Kenwright M, McDonough M: Computer-Aided Self-Exposure Therapy for Phobia/Panic Disorder: A Pilot Economic Evaluation. Cogn Behav Ther. 2009, 18: 1-9.

19.

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: 297-304. 10.1192/bjp.bp.109.073080.CrossRefPubMed

20.

Gerhards SA, de Graaf LE, Jacobs LE, Severens JL, Huibers MJ, Arntz A: Economic evaluation of online computerized cognitive-behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry. 2010, 196: 310-318. 10.1192/bjp.bp.109.065748.CrossRefPubMed

21.

National Institute for Health and Clinical Excellence: Computerized cognitive behavioural therapy for depression and anxiety: Review of Technology Appraisal 51. Technology Appraisal 97. http://guidance.nice.org.uk/TA97,

22.

Learmonth D, Rai S: Taking computerized CBT beyond primary care. Br J Clin Psychol. 2008, 47: 111-118. 10.1348/014466507X248599.CrossRefPubMed

23.

Purves DG, Bennett M, Wellman N: An open trial in the NHS of Blues Begone: a new home based computerized CBT program. Behav Cogn Psychother. 2009, 37: 541-551. 10.1017/S1352465809990282.CrossRefPubMed

24.

Cavanagh K, Shapiro DA, Van Den Berg S, Swain S, Barkham M, Proudfoot J: The effectiveness of computerized cognitive behavioural therapy in routine care. Br J Clin Psychol. 2006, 45: 499-514. 10.1348/014466505X84782.CrossRefPubMed

25.

Bennett-Levy J, Richards DA, Farrand P: Low intensity CBT interventions: a revolution in mental healthcare. Oxford guide to low intensity CBT interventions. Edited by: Bennett-Levy J, Richards DA, Farrand P. 2010, Oxford: Oxford University Press, 3-18.CrossRef

26.

Haby MM, Donnelly M, Corry J, Vos T: Cognitive behavioural therapy for depression, panic disorder, and generalized anxiety disorder: a meta-regression of factors that may predict outcome. Aust N Z J Psychiatry. 2005, 40: 9-19.CrossRef

27.

Gellatly J, Bower P, Hennessy S: What makes self-help interventions effective in the management of depressive symptoms? Meta-analysis and metaregression. Psychol Med. 2007, 37: 1217-1228. 10.1017/S0033291707000062.CrossRefPubMed

28.

Warmerdam L, van Straten A, Twisk J: Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res. 2008, 10: e44-10.2196/jmir.1094.CrossRefPubMedPubMedCentral

29.

De Graaf LE, Gerbards AH, Arntz H: Clinical effectiveness of online computerized cognitive–behavioural therapy without support for depression in primary care: randomised trial. Br J Psychiatry. 2009, 195: 73-80. 10.1192/bjp.bp.108.054429.CrossRefPubMed

30.

Waller R, Gilbody S: Barriers to the uptake of computerized cognitive behaviour therapy: a systematic review of the quantitative and qualitative evidency. Psychol Med. 2009, 39: 705-712. 10.1017/S0033291708004224.CrossRefPubMed

31.

Kaltenhthaler E, Sutcliffe E, Parry G, Beverley C, Rees A: The acceptability to patients of computerized cognitive behaviour therapy for depression: a systematic review. Psychol Med. 2008, 38: 1521-1530. 10.1017/S0033291707002607.CrossRef

32.

Mitchell N, Gordon PK: Attitudes towards computerized CBT for depression amongst a student population. Behav Cogn Psychother. 2007, 35: 421-430. 10.1017/S1352465807003700.CrossRef

33.

Wangberg SC, Gammon D, Spitznogle K: In the eyes of the beholder: exploring psychologists’ attitudes towards and use of e-therapy in Norway. Cyberpsychol Behav. 2007, 10: 418-422. 10.1089/cpb.2006.9937.CrossRefPubMed

34.

Beck AT, Ester RA, Ball R, Ranieri W: Comparison of Beck Depression Inventories -Ia and -II in psychiatric outpatients. J Pers Assess. 1996, 67: 588-597. 10.1207/s15327752jpa6703_13.CrossRefPubMed

35.

Sanz J, Garcia Vera MP, Espinosa R, Fortun M, Vazquez C: Adaptación española del Inventario para la Depresión de Beck II: Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud. 2005, 16: 121-142.

36.

Bellón JA, Moreno-Küstner B, Torres-González F, Montón-Franco C, GildeGómez-Barragán MJ, Sánchez-Celaya M: Predicting the onset and persistence of episodes of depression in primary health care. The predictD-Spain study: methodology. BMC Public Health. 2008, 8: 256-10.1186/1471-2458-8-256.CrossRefPubMedPubMedCentral

37.

Proudfoot J, Ryden C, Everitt B, Shapiro DA, Goldberg A, Mann A, Tylee A, Marks I, Gray JA: Clinical efficacy of computerized cognitive-behavioural therapy for anxiety and depression in primary care: randomised controlled trial. Br J Psychiatry. 2004, 185: 46-54. 10.1192/bjp.185.1.46.CrossRefPubMed

38.

Roca M, Gili M, Garcia-Garcia M, Salva J, Vives M, Garcia Campayo J, Comas A: Prevalence and comorbidity of common mental disorders in primary care. J Affect Disord. 2009, 119: 52-58. 10.1016/j.jad.2009.03.014.CrossRefPubMed

39.

García-Herrera JM, Nogueras-Morillas V, Muñoz-Cobos F, Morales-Asensio JM: Guía de Práctica Clínica para el Tratamiento de la Depresión en Atención Primaria [Clinical Practice Guide on the Treatment of Depression in Primary Care]. 2011, Distrito Sanitario Málaga UGC Salud Mental Hospital Regional Universitario “Carlos Haya”: Málaga

40.

Herrán A, Rodriguez B, Vazquez Barquero J: Psiquiatría en atención primaria. Edited by: Vazquez Barquero JL. 2007, Madrid: Aula Médica, 222-250.

41.

Beecham J, Knapp M: Costing psychiatric interventions. Measuring Mental Health Needs. Edited by: Thornicroft G. 2001, London: Gaskell

42.

Lecrubier Y, Sheehan D, Weiller E, Amorim P, Bonora I, Sheehan K, Janavs J, Dunbar G: The Mini International Neuropsychiatric Interview (M.I.N.I.), a short diagnostic interview: Reliability and validity according to the CIDI. Eur Psychiatry. 1997, 12: 232-241. 10.1016/S0924-9338(97)83297-X.CrossRef

43.

Ferrando L, Franco L, Soto M, Bobes J, Soto O, Franco L, Gibert J: MINI. MINI International Neuropsychiatric Interview. Versión en español 5.0.0. 1998, Madrid: IAP

44.

Badia X: EuroQol; un instrumento para valorar la salud EQ-5D guía del usuario, version española. Med Clin (Barc). 1999, 114: 6-14.

45.

Badia X, Roset M, Montserrat S, Herdman M, Segura A: The Spanish version of EuroQol: a description and its applications. European Quality of Life scale. Med Clin (Barc). 1999, 112 (Suppl 1): 79-85.

46.

Knapp M, PSSRU and Centre for Economics of Mental Health, Institute of Psychiatry, University of Kent: Economic Evaluation of Mental Health Care. 1995, Kent, GB: Ashgate Publishing Group

47.

Norman SB, Cissell SH, Means-Christensen AJ, Stein MB: Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depres Anxiety. 2006, 23: 245-249. 10.1002/da.20182.CrossRef

48.

Watson D, Clark L, Tellegen A: Development and validation of brief measures of positive and negative affect: The PANAS scales. J Personality Social Psychol. 1988, 54: 1063-1070.CrossRef

49.

Sandin B, Chorot P, Lostao L, Joiner T, Santed M, Valiente R: Escalas PANAS de afecto positivo y negativo: Validacion factorial y convergencia transcultural. Psicothema. 1999, 11: 37-51.

50.

Borkovec TD, Nau SD: Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry. 1972, 3: 257-260. 10.1016/0005-7916(72)90045-6.CrossRef

51.

Kazdin AE: Therapy outcome questions requiring control of credibility and treatment-generated expectancies. Behav Therapy. 1979, 10: 81-93. 10.1016/S0005-7894(79)80011-8.CrossRef

52.

Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000, 31 (2): 73-86. 10.1016/S0005-7916(00)00012-4.CrossRefPubMed

53.

Baños RM, Botella C, Guillén V, García-Palacios A, Jorquera M, Quero S: Un programa de tratamiento para los trastornos adaptativos: Un estudio de caso. Apunt Psicología. 2008, 26: 303-316.

54.

Schulz KF, Altman DG, Moher D, CONSORT Group: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010, 152: 726-732.CrossRefPubMed

55.

Van Hout BA, Al MJ, Gordon GS: Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994, 3: 309-319. 10.1002/hec.4730030505.CrossRefPubMed

56.

Mooney C, Duval R: Bootstrapping: A Non-parametric Approach to Statistical Inference. 1993, London: SageCrossRef

57.

Fenwick E, Claxton K, Sculpher M: Representing uncertainty: The role of cost-effectiveness acceptability curves. Health Econ. 2001, 10: 779-787. 10.1002/hec.635.CrossRefPubMed

58.

Fenwick E, Byford S: A guide to cost-effectiveness acceptability curves. Br J Psychiatry. 2005, 187: 106-108. 10.1192/bjp.187.2.106.CrossRefPubMed

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/13/21/prepub

Title: Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study
Authors: Yolanda López-del-Hoyo
Barbara Olivan
Juan V Luciano
Fermín Mayoral
Miquel Roca
Margalida Gili
Eva Andres
Antoni Serrano-Blanco
Francisco Collazo
Ricardo Araya
Rosa Baños
Cristina Botella
Rosa Magallón
Javier García-Campayo
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2013
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/1471-244X-13-21

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2013

Online cognitive behaviour training for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial protocol

Is computerised CBT really helpful for adult depression?-A meta-analytic re-evaluation of CCBT for adult depression in terms of clinical implementation and methodological validity

Internet-based interventions for eating disorders in adults: a systematic review

Detection of malingering: psychometric evaluation of the Chinese version of the structured interview of reported symptoms-2

Prevalence and clinical characteristics of patients with obsessive-compulsive disorder in first-episode psychosis

Preceding diagnoses to young adult bipolar disorder and schizophrenia in a nationwide study