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

BMC Psychiatry

Javier García-Campayo⁶  Rosa Magallón⁷  Cristina Botella⁷  Rosa Baños³  Ricardo Araya²  Francisco Collazo⁴  Antoni Serrano-Blanco⁸  Eva Andres^1,10  Margalida Gili⁵  Miquel Roca⁵  Fermín Mayoral⁹  Juan V Luciano⁸  Barbara Olivan¹  Yolanda López-del-Hoyo¹ 

[1] Departamento de Psicología y Sociología, Universidad de Zaragoza, Zaragoza, Spain;Academic Unit of Psychiatry, School of Social and Community Medicine, University of Bristol, Bristol, UK;Universidad de Valencia, Madrid, Spain;Servei de Psiquiatria, Hospital Universitari Vall d'Hebron, Barcelona, Spain;Institut Universitari d'Investigació en Ciències de la Salut (IUNICS), University of Balearic Islands, Palma de Mallorca, Spain;Ciber Fisiopatología de la Obesidad y Nutrición (CB06/03), Instituto de Salud Carlos III, Madrid, Spain;Universitat Jaume I, Castellon, Spain;Parc Sanitari Sant Joan de Déu and Fundación Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain;Psychiatric Service, University Hospital Carlos Haya, Malaga, Spain;Unidad Epidemiología Clínica, Hospital 12 de Octubre, CIBER Epidemiología y Salud Pública, Madrid, Spain

关键词: Randomized controlled trial;    Computer-delivered psychotherapy;    Depression;   

Others  :  1124172
DOI  :  10.1186/1471-244X-13-21

 received in 2012-08-07, accepted in 2013-01-04,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Lopez-del-Hoyo et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]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.
• [2]Sartorius N, Goldberg D, Girolamo G, Silva JA Ce, Lecrubier Y, Wittchen HU: Psychological disorders in general medical settings. New York: Hogrefe&Huber Publishers; 1990.
• [3]World Health Organization: The global burden of disease. Géneve: WHO; 2001.
• [4]Goldberg DP, Huxley P: Common mental disorders: A bio-social model. London: Routledge; 1992.
• [5]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.
• [6]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.
• [7]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.
• [8]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.
• [9]Lehtinen V, Riikonen E, Latineen E: Promotion of Mental Health on the European Agenda. Report. Finnish Ministry of Social Affairs and Health: Department for Prevention and Promotion; 2000.
• [10]Kaltenthaler E, Parry G, Beverley C, Ferriter M: Computerized cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry 2008, 193:181-184.
• [11]Marks IM, Cavanagh K, Gega L: Computer-aided psychotherapy: revolution or bubble? Br J Psychiatry 2007, 191:471-473.
• [12]Marks I, Cavanagh K: Computer-aided psychological treatments: evolving issues. Annu Rev Clin Psychol 2009, 5:121-141.
• [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.
• [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.
• [15]Titov N: Status of computerized cognitive behavioural therapy for adults. Aust N Z J Psychiatry 2007, 41:95-114.
• [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.
• [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.
• [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.
• [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.
• [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 webcite
• [22]Learmonth D, Rai S: Taking computerized CBT beyond primary care. Br J Clin Psychol 2008, 47:111-118.
• [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.
• [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.
• [25]Bennett-Levy J, Richards DA, Farrand P: Low intensity CBT interventions: a revolution in mental healthcare. In Oxford guide to low intensity CBT interventions. Edited by Bennett-Levy J, Richards DA, Farrand P. Oxford: Oxford University Press; 2010:3-18.
• [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.
• [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.
• [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.
• [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.
• [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.
• [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.
• [32]Mitchell N, Gordon PK: Attitudes towards computerized CBT for depression amongst a student population. Behav Cogn Psychother 2007, 35:421-430.
• [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.
• [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.
• [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. BioMed Central Full Text
• [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.
• [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.
• [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]. Distrito Sanitario Málaga UGC Salud Mental Hospital Regional Universitario “Carlos Haya”: Málaga; 2011.
• [40]Herrán A, Rodriguez B, Vazquez Barquero J: Psiquiatría en atención primaria. Edited by Vazquez Barquero JL. Madrid: Aula Médica; 2007:222-250.
• [41]Beecham J, Knapp M: Costing psychiatric interventions. In Measuring Mental Health Needs. Edited by Thornicroft G. London: Gaskell; 2001.
• [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.
• [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. Madrid: IAP; 1998.
• [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. Kent, GB: Ashgate Publishing Group; 1995.
• [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.
• [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.
• [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.
• [51]Kazdin AE: Therapy outcome questions requiring control of credibility and treatment-generated expectancies. Behav Therapy 1979, 10:81-93.
• [52]Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000, 31(2):73-86.
• [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.
• [55]Van Hout BA, Al MJ, Gordon GS: Costs, effects and C/E-ratios alongside a clinical trial. Health Econ 1994, 3:309-319.
• [56]Mooney C, Duval R: Bootstrapping: A Non-parametric Approach to Statistical Inference. London: Sage; 1993.
• [57]Fenwick E, Claxton K, Sculpher M: Representing uncertainty: The role of cost-effectiveness acceptability curves. Health Econ 2001, 10:779-787.
• [58]Fenwick E, Byford S: A guide to cost-effectiveness acceptability curves. Br J Psychiatry 2005, 187:106-108.