Evaluating an e-mental health program ("deprexis") as adjunctive treatment tool in psychotherapy for depression: design of a pragmatic randomized controlled trial

Tobias Krieger, Björn Meyer, Kerstin Sude, Antoine Urech, Andreas Maercker, Thomas Berger, Tobias Krieger, Björn Meyer, Kerstin Sude, Antoine Urech, Andreas Maercker, Thomas Berger

Abstract

Background: Major depressive disorder (MDD) places a significant disease burden on individuals as well as on societies. Several web-based interventions for MDD have shown to be effective in reducing depressive symptoms. However, it is not known whether web-based interventions, when used as adjunctive treatment tools to regular psychotherapy, have an additional effect compared to regular psychotherapy for depression.

Methods/design: This study is a currently recruiting pragmatic randomized controlled trial (RCT) that compares regular psychotherapy plus a web-based depression program ("deprexis") with a control condition exclusively receiving regular psychotherapy. Adults with a depressive disorder (N = 800) will be recruited in routine secondary care from therapists over the course of their initial sessions and will then be randomized within therapists to one of the two conditions. The primary outcome is depressive symptoms measured with the Beck Depression Inventory (BDI-II) at three months post randomization. Secondary outcomes include changes on various indicators such as anxiety, somatic symptoms and quality of life. All outcomes are again assessed at the secondary endpoint six months post randomization. In addition, the working alliance and feasibility/acceptability of the treatment condition will be explored.

Discussion: This is the first randomized controlled trial to examine the feasibility/acceptability and the effectiveness of a combination of traditional face-to-face psychotherapy and web-based depression program compared to regular psychotherapeutic treatment in depressed outpatients in routine care.

Trial registration: ISRCTN20165665.

Figures

Figure 1
Figure 1
Study design.

References

    1. Üstün T, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJ. Global burden of depressive disorders in the year 2000. Br J Psychiatry. 2004;184(5):386–392. doi: 10.1192/bjp.184.5.386.
    1. Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012;32(4):329–342. doi: 10.1016/j.cpr.2012.02.004.
    1. Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38:196–205. doi: 10.1080/16506070903318960.
    1. Cuijpers P, van Straten A, Andersson G, van Oppen P. Psychotherapy for depression in adults: a meta-analysis of comparative outcome studies. J Consult Clin Psychol. 2008;76(6):909–922. doi: 10.1037/a0013075.
    1. Cuijpers P, Donker T, Johansson R, Mohr DC, van Straten A, Andersson G. Self-guided psychological treatment for depressive symptoms: a meta-analysis. PLoS One. 2011;6:e21274. doi: 10.1371/journal.pone.0021274.
    1. Johansson R, Andersson G. Internet-based psychological treatments for depression. Expert Rev Neurother. 2012;12:861–870. doi: 10.1586/ern.12.63.
    1. Andersson G, Hesser H, Veilord A, Svedling L, Andersson F, Sleman O, Mauritzson L, Sarkohi A, Claesson E, Zetterqvist V. Randomised controlled non-inferiority trial with 3-year follow-up of internet-delivered versus face-to-face group cognitive behavioural therapy for depression. J Affect Disord. 2013;151(3):986–994. doi: 10.1016/j.jad.2013.08.022.
    1. 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:e10939. doi: 10.1371/journal.pone.0010939.
    1. Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: Is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011;31(1):89–103. doi: 10.1016/j.cpr.2010.09.008.
    1. Spek V, Cuijpers P, Nyklícek 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):319–328. doi: 10.1017/S0033291706008944.
    1. Andersson G, Titov N. Advantages and limitations of Internet based interventions for common mental disorders. World Psychiatry. 2014;13(1):4–11. doi: 10.1002/wps.20083.
    1. Przeworski A, Newman MG. Palmtop computer-assisted group therapy for social phobia. J Clin Psychol. 2004;60(2):179–188. doi: 10.1002/jclp.10246.
    1. Newman MG, Kenardy J, Herman S, Taylor CB. Comparison of palmtop-computer-assisted brief cognitive-behavioral treatment to cognitive-behavioral treatment for panic disorder. J Consult Clin Psychol. 1997;65(1):178–183. doi: 10.1037/0022-006X.65.1.178.
    1. Craske MG, Rose RD, Lang A, Welch SS, Campbell Sills L, Sullivan G, Sherbourne C, Bystritsky A, Stein MB, Roy Byrne PP. Computer assisted delivery of cognitive behavioral therapy for anxiety disorders in primary care settings. Depress Anxiety. 2009;26(3):235–242. doi: 10.1002/da.20542.
    1. Carroll K, Ball S, Martino S, Nich C, Babuscio T, Nuro K, Gordon M, Portnoy G, Rounsaville B. Computer-assisted delivery of cognitive-behavioral therapy for addiction: a randomized trial of CBT4CBT. Am J Psychiatry. 2008;165(7):881–888. doi: 10.1176/appi.ajp.2008.07111835.
    1. Carroll KM, Ball SA, Martino S, Nich C, Babuscio TA, Rounsaville BJ. Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. Drug Alcohol Depend. 2009;100(1):178–181. doi: 10.1016/j.drugalcdep.2008.09.015.
    1. Carroll KM, Kiluk BD, Nich C, Gordon MA, Portnoy GA, Marino DR, Ball SA. Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Am J Psychiatry. 2014;171(4):436–444. doi: 10.1176/appi.ajp.2013.13070987.
    1. Wright JH, Wright AS, Salmon P, Beck AT, Kuykendall J, Goldsmith LJ, Zickel MB. Development and initial testing of a multimedia program for computer-assisted cognitive therapy. Am J Psychother. 2002;56(1):76–86.
    1. Wright JH, Wright AS, Albano AM, Basco MR, Goldsmith LJ, Raffield T, Otto MW. Computer-assisted cognitive therapy for depression: maintaining efficacy while reducing therapist time. Am J Psychiatry. 2005;162(6):1158–1164. doi: 10.1176/appi.ajp.162.6.1158.
    1. Månsson KN, Ruiz ES, 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(12):e280. doi: 10.2196/jmir.3031.
    1. Clough BA, Casey LM. Technological adjuncts to increase adherence to therapy: a review. Clin Psychol Rev. 2011;31(5):697–710. doi: 10.1016/j.cpr.2011.03.006.
    1. Clough BA, Casey LM. Using SMS reminders in psychology clinics: a cautionary tale. Behav Cogn Psychother. 2014;42(3):257–268. doi: 10.1017/S1352465813001173.
    1. 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(2):e15. doi: 10.2196/jmir.1151.
    1. Moritz S, Schilling L, Hauschildt M, Schröder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012;50(7):513–521. doi: 10.1016/j.brat.2012.04.006.
    1. Berger T, Hämmerli 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(4):251–266. doi: 10.1080/16506073.2011.616531.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.
    1. Cuijpers P, Turner EH, Koole SL, Dijke A, Smit F. What is the threshold for a clinically relevant effect? The case of major depressive disorders. Depress Anxiety. 2014;31(5):374–378. doi: 10.1002/da.22249.
    1. Kühner C, Bürger C, Keller F, Hautzinger M. Reliabilität und Validität des revidierten Beck-Depressionsinventars (BDI-II): Befunde aus deutschsprachigen Stichproben. Nervenarzt. 2007;78(6):651–656. doi: 10.1007/s00115-006-2098-7.
    1. 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(3):e19. doi: 10.2196/jmir.1134.
    1. Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001;8(4):443–454. doi: 10.1177/107319110100800409.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Kroenke K, Spitzer RL, Williams JB, Löwe B. The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry. 2010;32(4):345–359. doi: 10.1016/j.genhosppsych.2010.03.006.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002;64(2):258–266. doi: 10.1097/00006842-200203000-00008.
    1. Ware JE, 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(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. 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(2):106–116. doi: 10.1026/0012-1924.55.2.106.
    1. Grawe K. Psychological Therapy. Seattle & Toronto: Hogrefe Publishing; 2004.
    1. Spreitzer GM. Psychological empowerment in the workplace: dimensions, measurement, and validation. Acad Manage J. 1995;38(5):1442–1465. doi: 10.2307/256865.
    1. Camerini L, Schulz PJ. Effects of functional interactivity on patients’ knowledge, empowerment, and health outcomes: an experimental model-driven evaluation of a web-based intervention. J Med Internet Res. 2012;14(4):e105. doi: 10.2196/jmir.1953.
    1. Wilmers F, Munder T, Leonhart R, Herzog T, Plassmann R, Barth J, Linster HW. Die deutschsprachige Version des Working Alliance Inventory–short revised (WAI-SR). Ein schulenübergreifendes, ökonomisches und empirisch validiertes Instrument zur Erfassung der therapeutischen Allianz. Klinische Diagnostik Evaluation. 2008;1(3):343–358.
    1. Horvath AO, Greenberg LS. Development and validation of the working alliance inventory. J Couns Psychol. 1989;36(2):223–233. doi: 10.1037/0022-0167.36.2.223.
    1. Gueorguieva R, Krystal JH. Move over anova: progress in analyzing repeated-measures data audits reflection in papers published in the archives of general psychiatry. Arch Gen Psychiatry. 2004;61(3):310–317. doi: 10.1001/archpsyc.61.3.310.
    1. Falkenström F, Markowitz JC, Jonker H, Philips B, Holmqvist R. Can psychotherapists function as their own controls? Meta-analysis of the “crossed therapist” design in comparative psychotherapy trials. J Clin Psychiatry. 2013;74(5):482–491. doi: 10.4088/JCP.12r07848.

Source: PubMed

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