Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial.
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/DESIGN
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.


DISCUSSION
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.


TRIAL REGISTRATION
Current Controlled Trials: ISRCTN12929657 . Date of registration: 8 September 2015.