Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

Generalized Anxiety Disorder Clinical Trial

Official title:

Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208348
• Other study ID #: Virtual Reality
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: April 23, 2018
• Start date: September 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: April 2018
• Source: Minnesota HealthSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder

Intervention

Other:
• Pilot Virtual Reality
Exposure to a virtual reality vignette with anxiety rating to support exposure therapy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minnesota HealthSolutions	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	through study completion, an average of one day study visit