STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure

Lars Clemmensen, Stéphane Bouchard, Johan Rasmussen, Trine Theresa Holmberg, Jakob Hyldig Nielsen, Jens Richardt Møllegaard Jepsen, Mia Beck Lichtenstein, Lars Clemmensen, Stéphane Bouchard, Johan Rasmussen, Trine Theresa Holmberg, Jakob Hyldig Nielsen, Jens Richardt Møllegaard Jepsen, Mia Beck Lichtenstein

Abstract

Background: Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program containing VR-based exposure. The intervention is targeted to adult patients suffering from SAD and treatment effect will be assessed by changes in SAD symptoms.

Methods: This article describes the study protocol of a Randomized Controlled Trial with three arms: 1) CBT with VR exposure based on 360° videos 2) CBT with in vivo exposure and 3) VR relaxation therapy. There will be 30 participants in each arm with a crossover at the end of the treatment period during which the participants in the third group will be randomly re-allocated to one of the two former groups. The treatment program consists of 10 weekly individual sessions with a psychologist, and a six month follow-up consisting of a questionnaire. The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS).

Discussion: There are currently no published studies on CBT with VR exposure based on 360° videos for SAD treatment. Furthermore, the current study will be the first Danish SAD treatment program that includes VR technology.

Trial registration: clinicaltrials.gov (NCT03973541) June 3rd 2019.

Keywords: Cognitive behavioral therapy; Exposure; Social anxiety; Virtual reality.

Conflict of interest statement

S.B. is consultant to and own equity in Cliniques et Développement In Virtuo, which develops virtual environments, and conflicts of interests are managed according to UQO’s conflict of interests policy; however, Cliniques et Développement In Virtuo did not create the virtual environments to be used in this study.

Figures

Fig. 1
Fig. 1
Overview of the patient pathways

References

    1. Alonso J, Lepine JP, Committee ESMS. Overview of key data from the European Study of the Epidemiology of Mental Disorders (ESEMeD). J Clin Psychiatry. 2007;68(Suppl 2).
    1. Craske MG, Stein MB. Anxiety. Lancet. 2016;388(10063).
    1. Stein DJ, et al. The cross-national epidemiology of social anxiety disorder: Data from the World Mental Health Survey Initiative. BMC Med. 2017;15(1).
    1. Keller MB. The lifelong course of social anxiety disorder: a clinical perspective. Acta Psychiatr Scand Suppl. 2003;417:85–94. doi: 10.1034/j.1600-0447.108.s417.6.x.
    1. Stein Murray B, Stein Dan J. Social anxiety disorder. The Lancet. 2008;371(9618):1115–1125. doi: 10.1016/S0140-6736(08)60488-2.
    1. Eng W, RG H. Social anxiety disorder. In: Freeman C, Power M, editors. Handbook of evidence-based psychotherapies A guide for research and practice. Chichester: John Wiley & Sons Ltd; 2007. pp. 367–383.
    1. Olfson M. Barriers to the Treatment of Social Anxiety. American Journal of Psychiatry. 2000;157(4):521–527. doi: 10.1176/appi.ajp.157.4.521.
    1. Schneier FR, et al. Social anxiety disorder and alcohol use disorder co-morbidity in the National Epidemiologic Survey on alcohol and related conditions. Psychol Med. 2010;40(6):977–988. doi: 10.1017/S0033291709991231.
    1. Kampmann IL, Emmelkamp PM, Morina N. Meta-analysis of technology-assisted interventions for social anxiety disorder. J Anxiety Disord. 2016;42:71–84. doi: 10.1016/j.janxdis.2016.06.007.
    1. Andersson G, P C. Social phobia (social anxiety disorder) In: Draper C, O’Donohue WT, editors. Stepped care and e-health: Practical applications to behavioral disorders. New York: Springer; 2011. pp. 99–114.
    1. Clark DM, et al. Cognitive therapy versus fluoxetine in generalized social phobia: a randomized placebo-controlled trial. J Consult Clin Psychol. 2003;71(6):1058–1067. doi: 10.1037/0022-006X.71.6.1058.
    1. Bouchard S, et al. Description of a treatment manual for in virtuo exposure with specific phobia. In: Eichenberg C, et al., editors. Virtual Reality in Psychological, Medical and Pedagogical Applications. Rijeka: InTech; 2012. pp. 82–108.
    1. Tardif N, Therrien CE, Bouchard S. Re-examining psychological mechanisms underlying virtual reality-based exposure for spider phobia. Cyberpsychol Behav Soc Netw. 2019;22(1):39–45. doi: 10.1089/cyber.2017.0711.
    1. Rodebaugh TL, Holaway RM, Heimberg RG. The treatment of social anxiety disorder. Clin Psychol Rev. 2004;24(7):883–908. doi: 10.1016/j.cpr.2004.07.007.
    1. Bouchard S, Côté S, Richard DC. Handbook of exposure therapies. 2007. Virtual reality applications for exposure; p. 42.
    1. Bouchard S, Wiederhold BK, Bossé J. Advances in virtual reality and anxiety disorders. 2014.
    1. Repetto C, et al. Virtual reality and mobile phones in the treatment of generalized anxiety disorders: a phase-2 clinical trial. Pers Ubiquit Comput. 2013;17(2):8. doi: 10.1007/s00779-011-0467-0.
    1. Gega L, Smith J, Reynolds S. Cognitive behaviour therapy (CBT) for depression by computer vs. therapist: patient experiences and therapeutic processes. Psychother Res. 2013;23(2):218–231. doi: 10.1080/10503307.2013.766941.
    1. Safir MP, Wallach HS, Bar-Zvi M. Virtual reality cognitive-behavior therapy for public speaking anxiety: one-year follow-up. Behav Modif. 2012;36(2):235–246. doi: 10.1177/0145445511429999.
    1. Fuch P, Moreau G, Guitton P. Virtual Reality: Concepts and Technologies. New York: CRC Press; 2011.
    1. Gregg L, Tarrier N. Virtual reality in mental health : a review of the literature. Soc Psychiatry Psychiatr Epidemiol. 2007;42(5):343–354. doi: 10.1007/s00127-007-0173-4.
    1. Flores-Arredondo JH, Assad-Kottner C. Virtual reality: a look into the past to fuel the future. Bull R Coll Surg Engl. 2015;97(10):3. doi: 10.1308/rcsbull.2015.424.
    1. Stupar-Rutenfrans S, Ketelaars LEH, van Gisbergen MS. Beat the fear of public speaking: Mobile 360 degrees video virtual reality exposure training in home environment reduces public speaking anxiety. Cyberpsychol Behav Soc Netw. 2017;20(10):624–633. doi: 10.1089/cyber.2017.0174.
    1. Garcia-Palacios A, et al. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. CyberPsychol Behav. 2007;10(5):722–724. doi: 10.1089/cpb.2007.9962.
    1. Gutierrez-Maldonado, J., B.K. Wiederhold, And G. Riva, Future Directions: How Virtual Reality Can Further Improve the Assessment and Treatment of Eating Disorders and Obesity. Cyberpsychol Behav Soc Netw, 2015.
    1. Levin MF, Weiss PL, Keshner EA. Emergence of virtual reality as a tool for upper limb rehabilitation: incorporation of motor control and motor learning principles. Phys Ther. 2015;95(3):415–425. doi: 10.2522/ptj.20130579.
    1. Freeman D, et al. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017;47(14):2393–2400. doi: 10.1017/S003329171700040X.
    1. Bouchard S, et al. Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. Br J Psychiatry. 2017;210(4):276–283. doi: 10.1192/bjp.bp.116.184234.
    1. Parsons TD, Rizzo AA. Affective outcomes of virtual reality exposure therapy for anxiety and specific phobias: a meta-analysis. J Behav Ther Exp Psychiatry. 2008;39(3):250–261. doi: 10.1016/j.jbtep.2007.07.007.
    1. Powers MB, Emmelkamp PM. Virtual reality exposure therapy for anxiety disorders: a meta-analysis. J Anxiety Disord. 2008;22(3):561–569. doi: 10.1016/j.janxdis.2007.04.006.
    1. Opris D, et al. Virtual reality exposure therapy in anxiety disorders: a quantitative meta-analysis. Depress Anxiety. 2012;29(2):85–93. doi: 10.1002/da.20910.
    1. Morina N, et al. Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Behav Res Ther. 2015;74:18–24. doi: 10.1016/j.brat.2015.08.010.
    1. Chesham RK, Malouff JM, Schutte NS. Meta-Analysis of the Efficacy of Virtual Reality Exposure Therapy for Social Anxiety. Behav Chang. 2018;1(15).
    1. Carl E, et al. Virtual reality exposure therapy for anxiety and related disorders: a meta-analysis of randomized controlled trials. J Anxiety Disord. 2019;61:27–36. doi: 10.1016/j.janxdis.2018.08.003.
    1. Harris SR, Kemmerling RL, North MM. Brief virtual reality therapy for public speaking anxiety. CyberPsychol Behav. 2002;5(6):543–550. doi: 10.1089/109493102321018187.
    1. Klinger E, et al. Virtual reality therapy versus cognitive behavior therapy for social phobia: a preliminary controlled study. CyberPsychol Behav. 2005;8(1):76–88. doi: 10.1089/cpb.2005.8.76.
    1. Anderson PL, et al. Virtual reality exposure therapy for social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2013;81(5):751–760. doi: 10.1037/a0033559.
    1. Kampmann IL, et al. Exposure to virtual social interactions in the treatment of social anxiety disorder: a randomized controlled trial. Behav Res Ther. 2016;77:147–156. doi: 10.1016/j.brat.2015.12.016.
    1. Robillard G, et al. Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. Stud Health Technol Inform. 2010;154:57–60.
    1. Castro Wenceslao Peñate, Roca Sánchez María José, Pitti González Carmen Teresa, Bethencourt Juan Manuel, de la Fuente Portero Juan Antonio, Marco Ramón Gracia. Cognitive-behavioral treatment and antidepressants combined with virtual reality exposure for patients with chronic agoraphobia. International Journal of Clinical and Health Psychology. 2014;14(1):9–17. doi: 10.1016/S1697-2600(14)70032-8.
    1. McCann RA, et al. Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. J Anxiety Disord. 2014;28(6):625–631. doi: 10.1016/j.janxdis.2014.05.010.
    1. Hart T, Fann JR, Novack TA. The dilemma of the control condition in experience-based cognitive and behavioural treatment research. Neuropsychol Rehabil. 2008;18(1):1–21. doi: 10.1080/09602010601082359.
    1. de Bruin M, et al. Standard care impact on effects of highly active antiretroviral therapy adherence interventions: a meta-analysis of randomized controlled trials. Arch Intern Med. 2010;170(3):11. doi: 10.1001/archinternmed.2009.536.
    1. Maples-Keller JL, et al. The use of virtual reality Technology in the Treatment of anxiety and other psychiatric disorders. Harv Rev Psychiatry. 2017;25(3):103–113. doi: 10.1097/HRP.0000000000000138.
    1. Gega L, et al. Virtual environments using video capture for social phobia with psychosis. Cyberpsychol Behav Soc Netw. 2013;16(6):473–479. doi: 10.1089/cyber.2013.1510.
    1. Price M, et al. Does engagement with exposure yield better outcomes? Components of presence as a predictor of treatment response for virtual reality exposure therapy for social phobia. J Anxiety Disord. 2011;25(6):763–770. doi: 10.1016/j.janxdis.2011.03.004.
    1. Peters L. Discriminant validity of the social phobia and anxiety inventory (SPAI), the social phobia scale (SPS) and the social interaction anxiety scale (SIAS) Behav Res Ther. 2000;38(9):943–950. doi: 10.1016/S0005-7967(99)00131-X.
    1. Harris PA, et al. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Clark DM, A W. A cognitive model of social phobia. In: Heimberg R, et al., editors. Social Phobia: Diagnosis, Assessment and Treatment: Guilford Press; 1995.
    1. Craske MG, et al. Optimizing inhibitory learning during exposure therapy. Behav Res Ther. 2008;46(1):5–27. doi: 10.1016/j.brat.2007.10.003.
    1. Craske MG, et al. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014;58:10–23. doi: 10.1016/j.brat.2014.04.006.
    1. Benbow AA, Anderson PL. A meta-analytic examination of attrition in virtual reality exposure therapy for anxiety disorders. J Anxiety Disord. 2019;61:18–26. doi: 10.1016/j.janxdis.2018.06.006.
    1. Webb NL, Drummond PD. The effect of swimming with dolphins on human well-being and anxiety. Anthrozoös. 2001;14(2):5. doi: 10.2752/089279301786999526.
    1. Present state examination : kort version til klinisk brug: GlaxoSmithKline; 2002.
    1. Brown Elissa J., Turovsky Julia, Heimberg Richard G., Juster Harlan R., et al Validation of the Social Interaction Anxiety Scale and the Social Phobia Scale across the anxiety disorders. Psychological Assessment. 1997;9(1):21–27. doi: 10.1037/1040-3590.9.1.21.
    1. Szende AGOTA. In: EQ-5D value sets: inventory, comparative review and user guide. Oppe NJDM, editor. Berlin: Springer; 2007.
    1. Herdman M, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20(10):1727–1736. doi: 10.1007/s11136-011-9903-x.
    1. Robillard G, et al. The development of the SWEAT questionnaire: a scale measuring costs and efforts inherent to conducting exposure sessions. Stud Health Technol Inform. 2011;167:105–110.
    1. Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the working Alliance inventory. Psychother Res. 2006;16:13. doi: 10.1080/10503300500352500.
    1. Kessler RC, et al. The World Health Organization Adult ADHD self-report scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005;35(2):13. doi: 10.1017/S0033291704002892.
    1. Constantino JN. Social responsiveness scale. New York: Springer; 2013.
    1. Simonoff E, et al. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008;47(8):921–929. doi: 10.1097/CHI.0b013e318179964f.
    1. Antshel KM, et al. Comorbid ADHD and anxiety affect social skills group intervention treatment efficacy in children with autism spectrum disorders. J Dev Behav Pediatr. 2011;32(6):439–446. doi: 10.1097/DBP.0b013e318222355d.
    1. Saunders JB, et al. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption--II. Addict. 1993;88(6):791–804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
    1. Hildebrand M. The psychometric properties of the drug use disorders identification test (DUDIT): a review of recent research. J Subst Abus Treat. 2015;53:52–59. doi: 10.1016/j.jsat.2015.01.008.
    1. Beck AT, Steer RA, Brown GK. Beck depression inventory-II. San Antonio. 1996;78(2):9.
    1. Grant BF, et al. The epidemiology of social anxiety disorder in the United States: results from the National Epidemiologic Survey on alcohol and related conditions. J Clin Psychiatry. 2005;66(11):1351–1361. doi: 10.4088/JCP.v66n1102.

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