Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

NCT03208348 | Completed

• 1 other identifier: Virtual Reality
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant experience in evaluating patient experiences and opinions of technologies intended to change behavior, will oversee a qualitative study to examine the prototype system. Twenty children with generalized anxiety disorder with perfectionism who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Qualitative response to the system as assessed by observation while using the system and interview following use.

  Twenty participants will provide qualitative data about their experience using the system.

  through study completion, an average of one day study visit

Secondary Outcomes (1)

• Anxiety as assessed by the Subjective Units of Distress Scale

  through study completion, an average of one day study visit

Study Arms (1)

Pilot virtual reality

EXPERIMENTAL

Children with anxiety will have a single visit to test the virtual reality system and measure its affects on their anxiety ratings.

Other: Pilot Virtual Reality

Interventions

Pilot Virtual Reality OTHER

Exposure to a virtual reality vignette with anxiety rating to support exposure therapy

Pilot virtual reality

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of Generalized Anxiety Disorder with perfectionism and have received less than three treatment sessions

You may not qualify if:

• too young to safely and effectively participate with the study materials

Sponsors & Collaborators

• Minnesota HealthSolutions: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sara Seifert, MPH

  Minnesota HealthSolutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single group will pilot test a virtual reality system that is designed to support mental health treatment.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: July 5, 2017
• Study Start: September 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)