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Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

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

Tracking Information
First Submitted Date  ICMJE June 1, 2017
First Posted Date  ICMJE July 5, 2017
Last Update Posted Date April 24, 2018
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Virtual Reality for Providing Exposure Therapy to Children
Official Title  ICMJE Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE Other: Pilot Virtual Reality
Exposure to a virtual reality vignette with anxiety rating to support exposure therapy
Study Arms  ICMJE 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.
Intervention: Other: Pilot Virtual Reality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03208348
Other Study ID Numbers  ICMJE Virtual Reality
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Minnesota HealthSolutions
Study Sponsor  ICMJE Minnesota HealthSolutions
Collaborators  ICMJE Mayo Clinic
Investigators  ICMJE
Principal Investigator: Sara Seifert, MPH Minnesota HealthSolutions
PRS Account Minnesota HealthSolutions
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP