title: Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Many patients with a psychotic disorder participate poorly in society. When psychotic disorders are in partial remission, feelings of paranoia, delusions of reference, social anxiety and self-stigmatization often remain at diminished severity and may lead to avoidance of places and people. Virtual reality exposure therapy (VRET) is an evidence-based treatment for several anxiety disorders. For patients with a psychotic disorder, the VRETp was developed to help them experience exposure to feared social situations. The present study aims to investigate the effects of VRETp on social participation in real life among patients with a psychotic disorder.
  
  
  METHODS
  The study is a single-blind randomized controlled trial with two conditions: the active condition, in which participants receive the virtual reality treatment together with treatment as usual (TAU), and the waiting list condition, in which participants receive TAU only. The two groups are compared at baseline, at 3 months posttreatment and at 6 months follow-up. All participants on the waiting list are also offered the virtual reality treatment after the follow-up measurements are completed. The primary outcome is social participation. Secondary outcomes are quality of life, interaction anxiety, depression and social functioning in general. Moderator and mediator analyses are conducted with stigma, cognitive schemata, cognitive biases, medication adherence, simulator sickness and presence in virtual reality. If effective, a cost-effectiveness analysis will be conducted.
  
  
  CONCLUSIONS
  Results from the posttreatment measurement can be considered strong empirical indicators of the effectiveness of VRETp. The 6-month follow-up data may provide reliable documentation of the long-term effects of the treatment on the outcome variables. Data from pre-treatment and mid-treatment can be used to reveal possible pathways of change.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN12929657 . Date of registration: 8 September 2015.
authors.affiliation: Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512 HN, Den Haag, The Netherlands. r.kolder@parnassiagroep.nl.|Department of Clinical Psychology, VU University and EMGO Institute for Health and Care Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands. r.kolder@parnassiagroep.nl.
authors.forename: Roos
authors.initials: R
authors.lastname: Pot-Kolder
authors.affiliation: University of Groningen, UMC Groningen, University Center of Psychiatry, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. w.veling@umcg.nl.
authors.forename: Wim
authors.initials: W
authors.lastname: Veling
authors.affiliation: University of Groningen, UMC Groningen, University Center of Psychiatry, Hanzeplein 1, 9700 RB, Groningen, The Netherlands. c.n.w.geraets@umcg.nl.
authors.forename: Chris
authors.initials: C
authors.lastname: Geraets
authors.affiliation: Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512 HN, Den Haag, The Netherlands. m.van.der.gaag@me.com.|Department of Clinical Psychology, VU University and EMGO Institute for Health and Care Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands. m.van.der.gaag@me.com.
authors.forename: Mark
authors.initials: M
authors.lastname: van der Gaag
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D016037:Single-Blind Method; D058992:Social Participation; D063367:Virtual Reality Exposure Therapy