The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention

BMC Psychiatry

Steffen Moritz^1,10  Eik Vettorazzi⁷  Gerhard Andersson⁴  Fritz Hohagen⁹  Viola Gräfe⁶  Matthias Rose⁵  Martin Hautzinger¹  Wolfgang Greiner⁶  Wolfgang Lutz²  Franz Caspar³  Björn Meyer⁸  Christina Späth⁹  Johanna Schröder^1,10  Thomas Berger³  Jan Philipp Klein⁹ 

[1] Department of Psychology, Clinical Psychology and Psychotherapy, Eberhard Karls University Tuebingen, Tuebingen, Germany;Department of Psychology, University of Trier, Trier, Germany;Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland;Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden;Department of Psychosomatic Medicine, Charité University Medical Center, Berlin, Germany;Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany;Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Department of Psychology, City University London, London, United Kingdom;Department of Psychiatry and Psychotherapy, Luebeck University, Luebeck, Germany;Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

关键词: Cost-of-illness analysis;    Health economic evaluation;    Randomized controlled trial;    Guided self-help;    Self-help;    Online psychological treatment;    Treatment;    Prevention;    Major depression;    Subclinical depression;   

Others  :  1123954
DOI  :  10.1186/1471-244X-13-239

 received in 2013-09-20, accepted in 2013-09-24,  发布年份 2013

【 摘 要 】

Background

Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.

Methods/Design

This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.

Discussion

The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.

Trial registration

Trial Registration Number:NCT01636752

【 授权许可】

   
2013 Klein et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Ustun TB, yuso-Mateos JL, Chatterji S, Mathers C, Murray CJ: Global burden of depressive disorders in the year 2000. Br J Psychiatry 2004, 184:386-392.
• [2]Kroenke K, Spitzer RL, Williams JB: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613.
• [3]Fava GA: Subclinical symptoms in mood disorders: pathophysiological and therapeutic implications. Psychol Med 1999, 29:47-61.
• [4]Rowe SK, Rapaport MH: Classification and treatment of sub-threshold depression. Curr Opin Psychiatry 2006, 19:9-13.
• [5]Rodriguez MR, Nuevo R, Chatterji S, yuso-Mateos JL: Definitions and factors associated with subthreshold depressive conditions: a systematic review. BMC Psychiatry 2012, 12:181. BioMed Central Full Text
• [6]Tomlinson M, Rudan I, Saxena S, Swartz L, Tsai AC, Patel V: Setting priorities for global mental health research. Bull World Health Organ 2009, 87:438-446.
• [7]Patel V, Maj M, Flisher AJ, De Silva MJ, Koschorke M, Prince M: Reducing the treatment gap for mental disorders: a WPA survey. World Psychiatry 2010, 9:169-176.
• [8]Kohn R, Saxena S, Levav I, Saraceno B: The treatment gap in mental health care. Bull World Health Organ 2004, 82:858-866.
• [9]Kazdin AE, Blase SL: Rebooting psychotherapy research and practice to reduce the burden of mental illness. Perspect Psychol Sci 2011, 6:21-37.
• [10]National Institute for Health and Clinical Excellence: Depression: the treatment and management of depression in aduls (partial update of NICE clinical guideline 23). London: National Institute for Health and Clinical Excellence; 2009.
• [11]Clark DM: Implementing NICE guidelines for the psychological treatment of depression and anxiety disorders: the IAPT experience. Int Rev Psychiatry 2011, 23:318-327.
• [12]Bennett-Levy J, Richards D, Farrand P, Christensen H, Griffiths K, Kavanagh D, Klein B, Lau MA, Proudfoot J, Ritterband L, et al.: Oxford guide to low intensity CBT interventions. Oxford: OUP; 2010.
• [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]Bower P, Kontopantelis E, Sutton A, Kendrick T, Richards DA, Gilbody S, Knowles S, Cuijpers P, Andersson G, Christensen H, et al.: Influence of initial severity of depression on effectiveness of low intensity interventions: meta-analysis of individual patient data. BMJ 2013, 346:f540.
• [15]Cuijpers P, Donker T, van Straten A, Li J, Andersson G: Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010, 40:1943-1957.
• [16]Johansson R, Andersson G: Internet-based psychological treatments for depression. Expert Rev Neurother 2012, 12:861-869.
• [17]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.
• [18]Richards D, Richardson T: Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev 2012, 32:329-342.
• [19]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, 37:319-328.
• [20]Klein JP, Berger T: Internetbasierte psychologische intervention bei depression. Verhaltenstherapie 2013, 23:149-159.
• [21]Berger T, Andersson G: Internet-based psychotherapies: characteristics and empirical evidence. Psychother Psychosom Med Psychol 2009, 59:159-166.
• [22]Cuijpers P, Donker T, Johansson R, Mohr DC, van SA, Andersson G: Self-guided psychological treatment for depressive symptoms: a meta-analysis. PLoS One 2011, 6:e21274.
• [23]Morgan AJ, Jorm AF, Mackinnon AJ: Email-based promotion of self-help for subthreshold depression: mood memos randomised controlled trial. Br J Psychiatry 2012, 200:412-418.
• [24]Bauer S, Wolf M, Haug S, Kordy H: The effectiveness of internet chat groups in relapse prevention after inpatient psychotherapy. Psychother Res 2011, 21:219-226.
• [25]Hollandare F, Johnsson S, Randestad M, Tillfors M, Carlbring P, Andersson G, Engstrom I: Randomized trial of Internet-based relapse prevention for partially remitted depression. Acta Psychiatr Scand 2011, 124:285-294.
• [26]Kroenke K, Spitzer RL, Williams JB, Lowe B: The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010, 32:345-359.
• [27]World medical association declaration of Helsinki: ethical principles for medical research involving human subjects JAMA 2000, 284:3043-3045.
• [28]Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869.
• [29]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(20):22-33.
• [30]Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960, 23:56-62.
• [31]Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S: The Columbia suicide severity rating scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011, 168:1266-1277.
• [32]Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M: Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res 2009, 11:e15.
• [33]Berger T, Hammerli K, Gubser N, Andersson G, Caspar F: Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther 2011, 40:251-266.
• [34]Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, et al.: 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.
• [35]Lowe B, Schenkel I, Carney-Doebbeling C, Gobel C: Responsiveness of the PHQ-9 to psychopharmacological depression treatment. Psychosomatics 2006, 47:62-67.
• [36]Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K: Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care 2004, 42:1194-1201.
• [37]Lowe B, Kroenke K, Herzog W, Grafe K: Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord 2004, 81:61-66.
• [38]McMillan D, Gilbody S, Richards D: Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods. J Affect Disord 2010, 127:122-129.
• [39]Donker T, van Straten A, Marks I, Cuijpers P: A brief Web-based screening questionnaire for common mental disorders: development and validation. J Med Internet Res 2009, 11:e19.
• [40]Hamilton M: Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967, 6:278-296.
• [41]Mohr DC, Hart SL, Julian L, Catledge C, Honos-Webb L, Vella L, Tasch ET: Telephone-administered psychotherapy for depression. Arch Gen Psychiatry 2005, 62:1007-1014.
• [42]Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, et al.: A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med 2000, 342:1462-1470.
• [43]Reynolds CF III, Dew MA, Pollock BG, Mulsant BH, Frank E, Miller MD, Houck PR, Mazumdar S, Butters MA, Stack JA, et al.: Maintenance treatment of major depression in old age. N Engl J Med 2006, 354:1130-1138.
• [44]Gullion CM, Rush AJ: Toward a generalizable model of symptoms in major depressive disorder. Biol Psychiatry 1998, 44:959-972.
• [45]Fliege H, Becker J, Walter OB, Rose M, Bjorner JB, Klapp BF: Evaluation of a computer-adaptive test for the assessment of depression (D-CAT) in clinical application. Int J Methods Psychiatr Res 2009, 18:23-36.
• [46]Fliege H, Becker J, Walter OB, Bjorner JB, Klapp BF, Rose M: Development of a computer-adaptive test for depression (D-CAT). Qual Life Res 2005, 14:2277-2291.
• [47]Ware J Jr, Kosinski M, Keller SD: A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
• [48]von der Schulenburg JM G, Greiner W, Jost F, Klusen N, Kubin M, Leidl R, Mittendorf T, Rebscher H, Schoeffski O, Vauth C, et al.: German recommendations on health economic evaluation: third and updated version of the Hanover Consensus. Value Health 2008, 11:539-544.
• [49]von der SJ, Vauth C, Mittendorf T, Greiner W: Methods for determining cost-benefit ratios for pharmaceuticals in Germany. Eur J Health Econ 2007, 8(1):S5-S31.
• [50]Tracey TJ, Kokotovic AM: Factor structure of the working alliance inventory. Psychol Assess: J Consult Clin Psychol 1989, 1:207.
• [51]Horvath AO, Greenberg LS: Development and validation of the working alliance inventory. J Couns Psychol 1989, 36:223-233.
• [52]Schmidt J, Lamprecht F, Wittmann WW: Satisfaction with inpatient management. Development of a questionnaire and initial validity studies. Psychother Psychosom Med Psychol 1989, 39:248-255.
• [53]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.
• [54]Lutz W, Schürch E, Stulz N, Böhnke JR, Schöttke H, Rogner J, Wiedl KH: Entwicklung und psychometrische Kennwerte des Fragebogens zur Evaluation von Psychotherapieverläufen (FEP). Diagnostica 2009, 55:106-116.
• [55]Lutz W, Böhnke JR: Der“ Fragebogen zur Evaluation von Psychotherapieverläufen”(FEP-2): Validierungen und Manual. Univ. Trier: Fachbereich I, Psychologie; 2008.
• [56]Grawe K: Psychological therapy. eMA MA: Hogrefe & Huber Cambridge; 2004.
• [57]Faul F, Erdfelder E, Lang AG, Buchner A: G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007, 39:175-191.
• [58]Lopez-del-Hoyo Y, Olivan B, Luciano JV, Mayoral F, Roca M, Gili M, Andres E, Serrano-Blanco A, Collazo F, Araya R, et al.: Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study. BMC Psychiatry 2013, 13:21. BioMed Central Full Text
• [59]Haynes B: Can it work? Does it work? Is it worth it? BMJ 2013, 319:652-653.
• [60]Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM: Statistics in medicine–reporting of subgroup analyses in clinical trials. N Engl J Med 2007, 357:2189-2194.
• [61]Donkin L, Hickie IB, Christensen H, Naismith SL, Neal B, Cockayne NL, Glozier N: Sampling bias in an internet treatment trial for depression. Transl Psychiatry 2012, 2:e174.
• [62]Cuijpers P, van Straten A, Schuurmans J, van Oppen P, Hollon SD, Andersson G: Psychotherapy for chronic major depression and dysthymia: a meta-analysis. Clin Psychol Rev 2010, 30:51-62.
• [63]Moritz S, Schroder J, Meyer B, Hauschildt M: The more it is needed, the less it is wanted: attitudes toward face-to-face intervention among depressed patients undergoing online treatment. Depress Anxiety 2013, 30:157-167.
• [64]Lutz W, Stulz N, Kock K: Patterns of early change and their relationship to outcome and follow-up among patients with major depressive disorders. J Affect Disord 2009, 118:60-68.
• [65]Stulz N, Lutz W, Leach C, Lucock M, Barkham M: Shapes of early change in psychotherapy under routine outpatient conditions. J Consult Clin Psychol 2007, 75:864-874.