Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
65

Summary

Conditions
  • Anxiety
  • Obsessive Compulsive Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to home exposure practice with or without the VR system, i.e., intervention or controlMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 7 years and 17 years
Gender
Both males and females

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 (...

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.

Tracking Information

NCT #
NCT03636022
Collaborators
Mayo Clinic
Investigators
Principal Investigator: Bridget Biggs, PhD Mayo Clinic