Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

• ClinicalTrials.gov Identifier: NCT03208348
• Recruitment Status: Completed
• First Posted: July 5, 2017
• Last Update Posted: April 24, 2018
• Sponsor: Minnesota HealthSolutions
• Collaborator: Mayo Clinic
• Information provided by (Responsible Party): Minnesota HealthSolutions

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder	Other: Pilot Virtual Reality	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A single group will pilot test a virtual reality system that is designed to support mental health treatment.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
• Actual Study Start Date: September 1, 2017
• Actual Primary Completion Date: January 31, 2018
• Actual Study Completion Date: January 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pilot virtual reality; 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; Exposure to a virtual reality vignette with anxiety rating to support exposure therapy

Outcome Measures

Primary Outcome Measures :

1. Qualitative response to the system as assessed by observation while using the system and interview following use. [ Time Frame: through study completion, an average of one day study visit ]
   Twenty participants will provide qualitative data about their experience using the system.

Secondary Outcome Measures :

1. Anxiety as assessed by the Subjective Units of Distress Scale [ Time Frame: through study completion, an average of one day study visit ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Minnesota HealthSolutions

Mayo Clinic

Investigators

• Principal Investigator: Sara Seifert, MPH; Minnesota HealthSolutions

More Information

• Responsible Party: Minnesota HealthSolutions
• ClinicalTrials.gov Identifier: NCT03208348
• Other Study ID Numbers: Virtual Reality
• First Posted: July 5, 2017
• Last Update Posted: April 24, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders