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Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilot Virtual Reality
Sponsored by
Minnesota HealthSolutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Generalized Anxiety Disorder

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot virtual reality

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anxiety as assessed by the Subjective Units of Distress Scale
Anxiety for each of the twenty participants will be assessed using SUDS prior to and after each time repeating the exposure. Participants will self-select how many times to repeat the exposure during the one day study visit.

Full Information

First Posted
June 1, 2017
Last Updated
April 23, 2018
Sponsor
Minnesota HealthSolutions
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03208348
Brief Title
Pilot Study of Virtual Reality for Providing Exposure Therapy to Children
Official Title
Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnesota HealthSolutions
Collaborators
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Twenty children with generalized anxiety disorder (perfectionism) who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC) using purposive sampling methods. Each patient will participate in a single (up to) 2-hour visit, allowing for breaks as needed. Staff from Mayo Clinic HealthCare Policy & Research experienced in qualitative data analysis and not involved with the patients' medical care or development of the prototype system will conduct the study visits. During the first 30 minutes the patient and parent will be introduced to the Virtual Reality system and the rationale for this feasibility study. Next, a therapist from the PADC, all of whom are experienced exposure therapists, will lead the patient through exposure exercises using the Virtual Reality system for up to 30 minutes. During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the Virtual Reality system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the Virtual Reality system. The data from the Virtual Reality system will be automatically transmitted to a cloud service running on a local laptop to study the effectiveness of the system's automatic logging capabilities. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the Virtual Reality system and then will ask for observations and opinions from the parent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group will pilot test a virtual reality system that is designed to support mental health treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot virtual reality
Arm Type
Experimental
Arm Description
Children with anxiety will have a single visit to test the virtual reality system and measure its affects on their anxiety ratings.
Intervention Type
Other
Intervention Name(s)
Pilot Virtual Reality
Intervention Description
Exposure to a virtual reality vignette with anxiety rating to support exposure therapy
Primary Outcome Measure Information:
Title
Qualitative response to the system as assessed by observation while using the system and interview following use.
Description
Twenty participants will provide qualitative data about their experience using the system.
Time Frame
through study completion, an average of one day study visit
Secondary Outcome Measure Information:
Title
Anxiety as assessed by the Subjective Units of Distress Scale
Description
Anxiety for each of the twenty participants will be assessed using SUDS prior to and after each time repeating the exposure. Participants will self-select how many times to repeat the exposure during the one day study visit.
Time Frame
through study completion, an average of one day study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of Generalized Anxiety Disorder with perfectionism and have received less than three treatment sessions Exclusion Criteria: too young to safely and effectively participate with the study materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Seifert, MPH
Organizational Affiliation
Minnesota HealthSolutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

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