Virtual Reality System for Anxiety and OCD
Condition: Anxiety; Obsessive-Compulsive Disorder
MeSH terms: Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for
      anxiety disorders. The investigators aim to enhance this therapy with the use of virtual
      reality exposures. The human subjects study will test the effects of using VR for exposures
      compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child
      engagement in an response to exposures, completion of exposure homework between treatment
      sessions, and length of treatment in weeks and length of treatment among children with
      anxiety disorders and/or obsessive compulsive disorder.

      The funding award supports the development of the technology and the human subjects study.
      The subcontract to Mayo supports expert input to identify clinically relevant content for
      therapeutic videos on the VR system and the human subjects study to test the VR system.
    

Detailed description: 
      Seventy children with childhood anxiety disorders (CADs) or obsessive compulsive disorder
      (OCD) and a parent will be recruited to test the Phase II VR system with a randomized
      controlled mixed methods study. Participants will be identified through the Mayo Clinic
      Pediatric Anxiety Disorders Clinic (PADC). Participants will be randomly assigned to home
      exposure practice with or without the VR system, i.e., intervention or control, respectively.
      All participants in the study will participate in an introductory session in which
      participants complete two exposures related to content from their fear ladder, one with the
      VR system and analogous imaginal exposure. Each family will receive instructions for how to
      use the Mayo Clinic Anxiety Coach tablet app to record exposures during home practice.
      Participants will then be assigned one week of daily exposure homework for the intervention
      and control conditions. Participants randomized to the intervention condition will take home
      the VR system for homework completion and participants assigned to control will be instructed
      to complete imaginal exposures. One week after the introductory session, all participants
      will return for a session in which participants complete both types of exposure. Participants
      will also be assigned to a third generalization exposure, i.e., an exposure related to the
      baseline exposure that is higher on the fear ladder, to complete at their next anxiety clinic
      treatment sessions. SUDS ratings for each type of exposure will be recorded electronically
      via the Mayo Clinic Anxiety Coach. During the follow up session, an independent interviewer
      will observe participants' engagement during exposure and will interview participants and
      their parents about their experience with both types of exposure.
    

Intervention name(s): VR System; Control
Intervention type(s): Other; Other
Intervention description(s): Use of virtual reality to deliver exposure therapy; Use of conventional delivery of exposure therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or control
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; OCD; Obsessive Compulsive Disorder; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety; GAD; Youth; Teen; Therapy; Specific Phobia; Children