Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial

Trials

Gerhard Andersson¹  Per Carlbring²  Kien Hoa Ly³ 

[1] Department of Clinical Neuroscience, Center for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden;Department of Psychology, Umeå University, Umeå, Sweden;Department of Behavioral Sciences and Learning, Swedish Institute for Disability Research, Linköping University, Linköping, Sweden

关键词: Controlled trial;    Randomized;    Cost-effectiveness;    Smartphone application;    Behavioral activation;    Depression;   

Others  :  1095583
DOI  :  10.1186/1745-6215-13-62

 received in 2011-11-24, accepted in 2012-05-18,  发布年份 2012

【 摘 要 】

Background

The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones). Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment.

Methods

The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, ‘Effective meditation’). The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period.

Discussions

We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist’s prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10 years it is now time to move to the next generation of information technology - smartphones - which are not only relevant for Swedish conditions but also for developing countries in the world which are increasingly empowered by mobile phones with Internet connection.

Trial registration

ClinicalTrials.gov NCT01463020

【 授权许可】

   
2012 Ly et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Ebmeier KP, Donaghey C, Steele JD: Recent developments and current controversies in depression. Lancet 2006, 367:153-167.
• [2]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, 9:193-200.
• [3]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 Psych 2008, 76:909-922.
• [4]Socialstyrelsen: Nationella riktlinjer för vård vid depression och ångestsyndrom 2010-Stöd för styrning och ledning. Socialstyrelsen, Stockholm; 2010.
• [5]Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H: 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.
• [6]Boschen MJ, Casey LM: The use of mobile telephones as adjuncts to cognitive behavioral psychotherapy. Prof Psychol-Res Pr 2008, 39:546-552.
• [7]Jacobson NS, Martell CR, Dimidjian S: Behavioral activation for depression: returning to contextual roots. Clin Psychol-Sci Pr 2001, 8:255-270.
• [8]Dimidjian S, Barrera M, Martell C, Muñoz RF, Lewinsohn PM: The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psych 2011, 7:1-38.
• [9]Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE: A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psych 1996, 64:295-304.
• [10]Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacoboson NS: Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psych 2006, 74:658-670.
• [11]Cuijpers P, van Straten A, Warmerdam L: Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev 2007, 27:318-326.
• [12]Martell CR, Dimidjian S, Herman-Dunn R: Behavioral Activation for Depression. Guilford Press, A Clinician’s Guide. New York; 2010.
• [13]Lewinsohn PM: A behavioral approach to depression. In The Psychology of Depression: Contemporary Theory and Research. Edited by Friedman RJ, Katz MM. Wiley, New York; 1974:157-185.
• [14]Kanter JW, Busch AM, Rusch LC: Behavioral Activation. Routledge, London; 2009.
• [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]Andersson G, Hesser H, Hummerdal D, Bergman-Nordgren L, Carlbring P: A 3.5- year follow-up of Internet-delivered cognitive behaviour therapy for major depression. J Ment Health 2011. Epub ahead of Print i
• [17]Andersson G: Internet-based cognitive-behavioral self help for depression. Expert Rev Neurother 2006, 6:1637-1642.
• [18]Howard KI, Moras K, Brill PL, Martinovich Z, Lutz W: Evaluation of psychotherapy. Efficacy, effectiveness, and patient progress. Am Psychol 1996, 51:1059-1064.
• [19]Andersson G, Bergström J, Holländare F, Carlbring P, Kaldo V, Ekselius L: Internet- based self-help for depression: a randomised controlled trial. Br J Psychiatry 2005, 187:456-461.
• [20]Bendelin N, Hesser H, Dahl J, Carlbring P, Zetterqvist Nelson K, Andersson G: Experiences of guided Internet-based cognitive-behavioral treatment for depression: A qualitative study. BMC Psychiatry 2011, 11:107. BioMed Central Full Text
• [21]Holländare F, Johnsson S, Randestad M, Tillfors M, Carlbring P, Andersson G, Engström I: Randomized trial of internet-based relapse prevention for partially remitted depression. Acta Psychiatr Scand 2011, 124:285-294.
• [22]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.
• [23]Vernmark K, Lenndin J, Bjärehed J, Carlsson M, Karlsson J, Öberg J, Carlbring P, Eriksson T, Andersson G: Internet administered guided self-help versus individualized e-mail therapy: A randomized trial of two versions of CBT for major depression. Behav Res Ther 2010, 48:368-376.
• [24]Andersson G: Using the Internet to provide cognitive behaviour therapy. Behav Res Ther 2009, 47:175-180.
• [25]Barak A, Klein B, Proudfoot JG: Defining internet-supported therapeutic interventions. Ann Behav Med 2009, 38:4-17.
• [26]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.
• [27]Andersson G, Cuijpers P: Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther 2009, 38:196-205.
• [28]Andersson G, Cuijpers P: Pros and cons of online cognitive-behavioral therapy. Br J Psychiatry 2008, 193:270-271.
• [29]Andersson G: The promise and pitfalls of the internet for cognitive behavioral therapy. BMC Med 2010, 8:82. BioMed Central Full Text
• [30]Andersson G, Bergström J, Holländare F, Lenndin J, Vernmark K: Ut ur depression och nedstämdhet med kognitiv beteendeterapi. Viva, Stockholm; 2007.
• [31]Christensen H, Griffiths K, Groves C, Korten A: Free range users and one hit wonders: community users of an Internet-based cognitive behaviour therapy program. Aust N Z J Psychiatry 2006, 40:59-62.
• [32]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, 20(Suppl):22-33. quiz 34–57
• [33]Crippa JAS, de Lima Osório F, Del-Ben CM, Filho AS, da Silva Freitas MC, Loureiro SR: Comparability between telephone and face-to-face structured clinical interview for DSM-IV in assessing social anxiety disorder. Perspec Psychiatr C 2008, 44:241-247.
• [34]Rohde P, Lewinsohn PM, Seeley JR: Comparability of telephone and face-to-face interviews in assessing axis I and II disorders. Am J Psychiat 1997, 154:1593-1598.
• [35]Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry 1961, 4:561-571.
• [36]Kroenke K, Spitzer RL, Williams JB: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613.
• [37]Wittkampf K, Naeije L, Schene A, Huyser J, Van Weert H: Diagnostic accuracy of the mood module of the Patient Health Questionnaire: a systematic review. Gen Hosp Psychiat 2007, 29:388-395.
• [38]Beck AT, Steer RA: Beck depression inventory. Manual, Svensk version (Swedish version). Psykologiförlaget AB, Fagernes; 1996.
• [39]Beck AT, Steer RA, Garbin MG: Psychometric properties of the Beck Depression Inventory: twenty five years of evaluation. Clin Psychol Rev 1988, 8:77-100.
• [40]Guy W: Clinical Global Impressions, In ECDEU Manual, US Dept of Health and Human Services. NIMH, Rockville, MD; 1976:217-222.
• [41]Thorndike FP, Carlbring P, Smyth FL, Magee J, Gonder-Frederick L, Öst LG, Ritterband LM: Web-based measurement: effect of completing single or multiple items per webpage. Comput Hum Behav 2009, 25:393-401.
• [42]Beck AT, Epstein N, Brown G, Steer RA: An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psych 1988, 56:893-897.
• [43]Frisch MB, Cornell J, Villanueva M: Clinical validation of the Quality of life inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assessment 1992, 4:92-101.
• [44]Hayes SC, Strosahl KD, Bunting K, Twohig M, Wilson KG: What is Acceptance and Commitment Therapy? In A Practical Guide to Acceptance and Commitment Therapy. Edited by Hayes SC, Strosahl KD. Springer Science Business Media, New York; 2004:1-30.
• [45]de Beurs E, Wilson KA, Chambless DL, Goldstein AJ, Feske U: Convergent and divergent validity of the Beck Anxiety Inventory for patients with panic disorder and agoraphobia. Depress Anxiety 1997, 6:140-146.
• [46]Hakkaart-van Roijen L, van Straten A, Donker M: Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Erasmus University, Rotterdam; 2002.
• [47]The EuroQol Group: EuroQol–a new facility for the measurement of health-related quality of life. EuroQol Group Health Policy 1990, 16:199-208.
• [48]Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Investig 2001, 357:1191-1194.
• [49]Proudfoot J, Klein B, Barak A, Carlbring P, Cuijpers P, Lange A, Ritterband LM, Andersson G: Establishing guidelines for executing and reporting internet intervention research. Cogn Behav Ther 2011, 40:82-97.
• [50]Gueorguieva R, Krystal JH: Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry 2004, 61:310-317.