title: Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial.
abstract: BACKGROUND
  Traditional one-session exposure therapy (OST) in which a patient is gradually exposed to feared stimuli for up to 3 h in a one-session format has been found effective for the treatment of specific phobias. However, many individuals with specific phobia are reluctant to seek help, and access to care is lacking due to logistic challenges of accessing, collecting, storing, and/or maintaining stimuli. Virtual reality (VR) exposure therapy may improve upon existing techniques by facilitating access, decreasing cost, and increasing acceptability and effectiveness. The aim of this study is to compare traditional OST with in vivo spiders and a human therapist with a newly developed single-session gamified VR exposure therapy application with modern VR hardware, virtual spiders, and a virtual therapist.
  
  
  METHODS
  Participants with specific phobia to spiders (N = 100) will be recruited from the general public, screened, and randomized to either VR exposure therapy (n = 50) or traditional OST (n = 50). A behavioral approach test using in vivo spiders will serve as the primary outcome measure. Secondary outcome measures will include spider phobia questionnaires and self-reported anxiety, depression, and quality of life. Outcomes will be assessed using a non-inferiority design at baseline and at 1, 12, and 52 weeks after treatment.
  
  
  CONCLUSIONS
  VR exposure therapy has previously been evaluated as a treatment for specific phobias, but there has been a lack of high-quality randomized controlled trials. A new generation of modern, consumer-ready VR devices is being released that are advancing existing technology and have the potential to improve clinical availability and treatment effectiveness. The VR medium is also particularly suitable for taking advantage of recent phobia treatment research emphasizing engagement and new learning, as opposed to physiological habituation. This study compares a market-ready, gamified VR spider phobia exposure application, delivered using consumer VR hardware, with the current gold standard treatment. Implications are discussed.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT02533310. Registered on 25 August 2015.
authors.affiliation: Department of Psychology, Stockholm University, Frescati Hagväg 8, 106 91, Stockholm, Sweden. alexander.miloff@psychology.su.se.
authors.forename: Alexander
authors.initials: A
authors.lastname: Miloff
authors.affiliation: Department of Psychology, Stockholm University, Frescati Hagväg 8, 106 91, Stockholm, Sweden. philip.lindner@ki.se.|Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. philip.lindner@ki.se.
authors.forename: Philip
authors.initials: P
authors.lastname: Lindner
authors.affiliation: Department of Psychology, Stockholm University, Frescati Hagväg 8, 106 91, Stockholm, Sweden. william@mimerse.com.|Mimerse, Stockholm, Sweden. william@mimerse.com.
authors.forename: William
authors.initials: W
authors.lastname: Hamilton
authors.affiliation: Department of Psychology, Stockholm University, Frescati Hagväg 8, 106 91, Stockholm, Sweden. lsm@psychology.su.se.
authors.forename: Lena
authors.initials: L
authors.lastname: Reuterskiöld
authors.affiliation: Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. gerhard.andersson@liu.se.|Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden. gerhard.andersson@liu.se.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Andersson
authors.affiliation: Department of Psychology, Stockholm University, Frescati Hagväg 8, 106 91, Stockholm, Sweden. per@carlbring.se.
authors.forename: Per
authors.initials: P
authors.lastname: Carlbring
mesh_terms: D000328:Adult; D000818:Animals; D006801:Humans; D002985:Clinical Protocols; D017063:Outcome Assessment, Health Care; D010698:Phobic Disorders / Q000628:therapy; D013112:Spiders; D063367:Virtual Reality Exposure Therapy / Q000379:methods; D000074099:Equivalence Trials as Topic
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