Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial

Burçin Ünlü Ince, Didem Gökçay, Heleen Riper, Pim Cuijpers, Burçin Ünlü Ince, Didem Gökçay, Heleen Riper, Pim Cuijpers

Abstract

Background: In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.

Objective: This study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey.

Methods: Participants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline).

Results: We will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1).

Conclusions: Results from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms.

Trial registration: ClinicalTrials.gov NCT03754829; https://ichgcp.net/clinical-trials-registry/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7).

International registered report identifier (irrid): DERR1-10.2196/13239.

Keywords: depression; depressive symptoms; mobile app; psychotherapy; randomized controlled trial; telemedicine.

Conflict of interest statement

Conflicts of Interest: HŞKA was developed in collaboration with the online counseling center Ruhuna İyi Bak, the IT Enterprise Doksan6, and the project group. The VU University owns the copyrights of HŞKA.

©Burçin Ünlü Ince, Didem Gökçay, Heleen Riper, Pim Cuijpers. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.04.2019.

Figures

Figure 1
Figure 1
Flowchart of the study phases.
Figure 2
Figure 2
Flowchart of the randomized controlled trial. BDI-II: Beck Depression Inventory-II; MINI: Mini-International Neuropsychiatric Interview.

References

    1. RUSIHAK . Human Rights in Mental Health Field 2008 Turkey Report - Issues and Proposed Solutions. Istanbul, Turkey: Human Rights In Mental Health Initiative Association; 2008.
    1. RUSIHAK . Comparative Approaches to Human Rights and Social Policy in the Light - Mental Health Policies in Turkey: Assessment and Recommendations. Istanbul, Turkey: Human Rights In Mental Health Initiative Association; 2012.
    1. World Health Organization. 2017. [2018-11-29]. Infographic - Depression in Turkey .
    1. Binbay T, Direk N, Aker T, Akvardar Y, Alptekin K, Cimilli C, Cam B, Deveci A, Kadri Gültekin B, Sar V, Taycan O, Ulaş H. Psychiatric epidemiology in Turkey: main advances in recent studies and future directions. Turk Psikiyatri Derg. 2014;25(4):264–81. doi: 10.5080/u7463.
    1. World Health Organization . Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017.
    1. Saarni SI, Suvisaari J, Sintonen H, Pirkola S, Koskinen S, Aromaa A, Lönnqvist J. Impact of psychiatric disorders on health-related quality of life: general population survey. Br J Psychiatry. 2007 Apr;190:326–32. doi: 10.1192/bjp.bp.106.025106. doi: 10.1192/bjp.bp.106.025106.
    1. Ustün TB, Ayuso-Mateos JL, Chatterji S, Mathers C, Murray CJ. Global burden of depressive disorders in the year 2000. Br J Psychiatry. 2004 May;184:386–92. doi: 10.1192/bjp.184.5.386.
    1. Barney LJ, Griffiths KM, Jorm AF, Christensen H. Stigma about depression and its impact on help-seeking intentions. Aust N Z J Psychiatry. 2006 Jan;40(1):51–4. doi: 10.1111/j.1440-1614.2006.01741.x.
    1. Greenberg PE, Birnbaum HG. The economic burden of depression in the US: societal and patient perspectives. Expert Opin Pharmacother. 2005 Mar;6(3):369–76. doi: 10.1517/14656566.6.3.369.
    1. 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 Dec;9(4):193–200.
    1. Cuijpers P, Vogelzangs N, Twisk J, Kleiboer A, Li J, Penninx BW. Comprehensive meta-analysis of excess mortality in depression in the general community versus patients with specific illnesses. Am J Psychiatry. 2014 Apr;171(4):453–62. doi: 10.1176/appi.ajp.2013.13030325.
    1. Arroll B, Elley CR, Fishman T, Goodyear-Smith FA, Kenealy T, Blashki G, Kerse N, Macgillivray S. Antidepressants versus placebo for depression in primary care. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007954. doi: 10.1002/14651858.CD007954.
    1. Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF. The efficacy of psychotherapy and pharmacotherapy in treating depressive and anxiety disorders: a meta-analysis of direct comparisons. World Psychiatry. 2013 Jun;12(2):137–48. doi: 10.1002/wps.20038. doi: 10.1002/wps.20038.
    1. Churchill R, Hunot V, Corney R, Knapp M, McGuire H, Tylee A, Wessely S. A systematic review of controlled trials of the effectiveness and cost-effectiveness of brief psychological treatments for depression. Health Technol Assess. 2001;5(35):1–173.
    1. Hofmann SG, Asnaani A, Vonk IJJ, Sawyer AT, Fang A. The efficacy of cognitive behavioral therapy: a review of meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427–40. doi: 10.1007/s10608-012-9476-1.
    1. Riper H, Andersson G, Christensen H, Cuijpers P, Lange A, Eysenbach G. Theme issue on e-mental health: a growing field in internet research. J Med Internet Res. 2010;12(5):e74. doi: 10.2196/jmir.1713.
    1. Internet World Stats. 2017. [2018-11-29]. Internet Stats and Facebook Usage in Europe June 2017 Statistics .
    1. We Are Social. [2019-02-12]. Global Digital Report 2018 .
    1. Ritterband LM, Thorndike F. Internet interventions or patient education web sites? J Med Internet Res. 2006;8(3):e18; author reply e19. doi: 10.2196/jmir.8.3.e18.
    1. Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196–205. doi: 10.1080/16506070903318960.
    1. Cuijpers P, de Wit L, Kleiboer A, Karyotaki E, Ebert DD. Problem-solving therapy for adult depression: an updated meta-analysis. Eur Psychiatry. 2018 Dec;48:27–37. doi: 10.1016/j.eurpsy.2017.11.006.
    1. Warmerdam L, van Straten A, Twisk J, Riper H, Cuijpers P. Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res. 2008;10(4):e44. doi: 10.2196/jmir.1094.
    1. Bowman D, Scogin F, Lyrene B. The efficacy of self-examination therapy and cognitive bibliotherapy in the treatment of mild to moderate depression. Psychother Res. 1995;5(2):131–40. doi: 10.1080/10503309512331331256.
    1. Gökçay D, Çınar MO, Yüceil S, Yılmaz S, Çiçek NM, Köybaşı NA, Başgöze Z, İnce U. Top Sende: Problem Solving based Online Behavioral Therapy (in Turkish). Proceedings of 10th Medical Informatics Congress; 2017; Antalya. Top Sende: Problem Solving based Online Behavioral Therapy (in Turkish). Proceedings of 10th Medical Informatics Congress; 2017.
    1. Ünlü Ince B, Cuijpers P, van 't Hof E, van Ballegooijen W, Christensen H, Riper H. Internet-based, culturally sensitive, problem-solving therapy for Turkish migrants with depression: randomized controlled trial. J Med Internet Res. 2013;15(10):e227. doi: 10.2196/jmir.2853.
    1. Ünlü Ince B, Cuijpers P, van 't Hof E, Riper H. Reaching and recruiting Turkish migrants for a clinical trial through Facebook: a process evaluation. Internet Interv. 2014 Apr;1(2):74–83. doi: 10.1016/j.invent.2014.05.003.
    1. Backhaus A, Agha A, Maglione ML, Repp A, Ross B, Zuest D, Rice-Thorp NM, Lohr J, Thorp SR. Videoconferencing psychotherapy: a systematic review. Psychol Serv. 2012 May;9(2):111–31. doi: 10.1037/a0027924.
    1. Vis C, Kleiboer A, Prior R, Bønes E, Cavallo M, Clark SA, Dozeman E, Ebert D, Etzelmueller A, Favaretto G, Zabala AF, Kolstrup N, Mancin S, Mathiassen K, Myrbakk VN, Mol M, Jimenez JP, Power K, van Schaik A, Wright C, Zanalda E, Pederson CD, Smit J, Riper H. Implementing and up-scaling evidence-based eMental health in Europe: The study protocol for the MasterMind project. Internet Interv. 2015 Nov;2(4):399–409. doi: 10.1016/j.invent.2015.10.002.
    1. Lindhiem O, Bennett CB, Rosen D, Silk J. Mobile technology boosts the effectiveness of psychotherapy and behavioral interventions: a meta-analysis. Behav Modif. 2015 Nov;39(6):785–804. doi: 10.1177/0145445515595198.
    1. Aguilera A, Bruehlman-Senecal E, Demasi O, Avila P. Automated text messaging as an adjunct to cognitive behavioral therapy for depression: a clinical trial. J Med Internet Res. 2017 May 8;19(5):e148. doi: 10.2196/jmir.6914.
    1. Agyapong VI, Juhás M, Ohinmaa A, Omeje J, Mrklas K, Suen VY, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.
    1. Unlü B, Riper H, van Straten A, Cuijpers P. Guided self-help on the internet for Turkish migrants with depression: the design of a randomized controlled trial. Trials. 2010;11:101. doi: 10.1186/1745-6215-11-101.
    1. Bernal G, Domenech RM. Cultural adaptation in context: psychotherapy as a historical account of adaptations. In: Bernal G, Domenech RM, editors. Cultural Adaptations: Tools for Evidence-Based Practice With Diverse Populations. USA: American Psychological Association; 2012. pp. 3–22.
    1. Take Care of Your Soul. [2018-12-18]. Everything Under Control - Web intervention .
    1. Beck A, Steer R, Brown G. Beck Depression Inventory-II (BDI-II) San Antonio, TX: Psychological Corporation New York; 1996.
    1. Lecrubier Y, Sheehan D, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Janavs J, Dunbar G. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997;12(5):224–31. doi: 10.1016/S0924-9338(97)83296-8.
    1. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33;quiz 34.
    1. Kapci EG, Uslu R, Turkcapar H, Karaoglan A. Beck Depression Inventory II: evaluation of the psychometric properties and cut-off points in a Turkish adult population. Depress Anxiety. 2008;25(10):E104–10. doi: 10.1002/da.20371.
    1. Holländare F, Gahnström A, Nieminen A, Engström I. Can the BDI-II and MADRS-S be transferred to online use without affecting their psychometric properties? J Appl Psychol. 2009 Jan 30;4(2):63–5. doi: 10.7790/ejap.v4i2.122.
    1. Uslu RI, Kapci EG, Oncu B, Ugurlu M, Turkcapar H. Psychometric properties and cut-off scores of the Beck Depression Inventory-II in Turkish adolescents. J Clin Psychol Med Settings. 2008 Sep;15(3):225–33. doi: 10.1007/s10880-008-9122-y.
    1. Spielberger C, Gorsuch R, Lushene R, Vagg P, Jacobs G. eProvide. 1983. [2019-03-13]. State-trait anxiety inventory (form Y) .
    1. Öner N, Le CA. [State Trait Anxiety Inventory Manual] İstanbul: Boğaziçi Üniversitesi Yayınları; 1985.
    1. Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487–95. doi: 10.1016/0005-7967(90)90135-6.
    1. Zlomke KR. Psychometric properties of internet administered versions of Penn State Worry Questionnaire (PSWQ) and Depression, Anxiety, and Stress Scale (DASS) Comput Hum Behav. 2009 Jul;25(4):841–3. doi: 10.1016/j.chb.2008.06.003.
    1. Boysan M, Keskin S, Beşiroğlu L. [Hierarchical factor structure, validity and reliability of the Penn State Worry Scale Turkish Form] [Bullet Clinic Psychopharmaco] 2008;18(3)
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385–96. doi: 10.2307/2136404.
    1. Roberti J, Harrington L, Storch E. Further psychometric support for the 10-item version of the perceived stress scale. J Coll Couns. 2006;9(2):135–47. doi: 10.1002/j.2161-1882.2006.tb00100.x.
    1. Eskin M, Harlak H, Demirkıran F. [Adaptation of perceived stress scale to Turkish: Reliability and validity analysis] New/Yeni Symposium Journal. 2013;51(3)
    1. Schwarzer R, Jerusalem M. Extreme Stress and Communities: Impact and Intervention. Dordrecht: Springer; 1995. Optimistic self-beliefs as a resource factor in coping with stress.
    1. Aypay A. The adaptation study of General Self-Efficacy (GSE) Scale to Turkish. Inonu Univ J Faculty Educ. 2010;11(2)
    1. Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. Mulhern B, O'Gorman H, Rotherham N, Brazier J. Comparing the measurement equivalence of EQ-5D-5L across different modes of administration. Health Qual Life Outcomes. 2015 Nov 26;13:191. doi: 10.1186/s12955-015-0382-6.
    1. Kahyaoğlu Süt H, Unsar S. Is EQ-5D a valid quality of life instrument in patients with acute coronary syndrome? Anadolu Kardiyol Derg. 2011 Mar;11(2):156–62. doi: 10.5152/akd.2011.037.
    1. Çetin Kaya Y. Middle East Technical University. Ankara: Department of Information Systems, Middle East Technical University (METU); 2014. [2019-03-13]. Identification of factors affecting the e-service adoption: an empirical investigation .
    1. Faul F, Erdfelder E, Buchner A, Lang A. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149–60. doi: 10.3758/BRM.41.4.1149.
    1. Sealed Envelope. [2019-02-12]. .
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. doi: 10.1186/1741-7015-8-18.
    1. IBM Corp. 2014. [2019-03-13]. IBM SPSS statistics for windows, version 24 .
    1. Fisher L, Dixon D, Herson J, Frankowski R, Hearron M, Peace K. Intention to treat in clinical trials. In: Peace KE, editor. Statistical Issues in Drug Research and Development. New York: Marcel Dekker; 1990. pp. 331–50.
    1. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12–9. doi: 10.1037/0022-006X.59.1.12.
    1. Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB. Methods for defining and determining the clinical significance of treatment effects: description, application, and alternatives. J Consult Clin Psychol. 1999 Jun;67(3):300–7. doi: 10.1037/0022-006X.67.3.300.
    1. Iqbal ST, Horvitz E. Notifications and awareness: a field study of alert usage and preferences. Proceedings of the 2010 ACM conference on Computer supported cooperative work; CSCW'10; February 6-10, 2010; Georgia, USA. 2010. pp. 27–30.
    1. Eysenbach G. The law of attrition. J Med Internet Res. 2005;7(1):e11. doi: 10.2196/jmir.7.1.e11.
    1. Christensen H, Mackinnon A. The law of attrition revisited. J Med Internet Res. 2006;8(3):e20; author reply e21. doi: 10.2196/jmir.8.3.e20.

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