- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636022
Virtual Reality System for Anxiety and OCD
Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in an response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder.
The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deanna R Hofschule
- Phone Number: 507-255-2972
- Email: hofschulte.deanna@mayo.edu
Study Contact Backup
- Name: Bridget K Biggs, Ph.D., L.P.
- Phone Number: 507-255-2972
- Email: biggs.bridget@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 7 to 17
- Primary diagnosis of an anxiety disorder or obsessive compulsive disorder.
Exclusion Criteria:
- History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder.
- Current sucidality or recent suicidal behavior.
- Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties.
- Starting or changing the dosage of psychiatric medications in the last 2 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR System
Participants will then be assigned one week of daily exposure homework.
Patients randomized to the intervention condition will take home the VR system for homework.
|
Use of virtual reality to deliver exposure therapy
|
Experimental: Control Condition
Participants will then be assigned one week of daily exposure homework.
Participants assigned to control will be instructed to complete imaginal exposures.
|
Use of conventional delivery of exposure therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session
Time Frame: 2 hours
|
The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress.
|
2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bridget Biggs, PhD, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MinnesotaHealthSolutions
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive-Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
Clinical Trials on VR System
-
University of Alabama at BirminghamCompleted
-
Clarity Health Technologies, IncSymmetryScience Group, Inc.RecruitingAlzheimer Disease | Healthy AgingUnited States
-
Peking Union Medical College HospitalRecruiting
-
Demaod LtdRecruiting
-
University of Witten/HerdeckeFH Münster University of Applied Sciences; The Witten Institute For Family...RecruitingPsychological and Systems FunctioningGermany
-
6Degrees LTDSheba Medical CenterRecruiting
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Enrolling by invitation
-
Abbott Medical DevicesActive, not recruitingBradycardia | Cardiac Rhythm DisorderUnited States, United Kingdom, Canada, Italy, France, Czechia, Netherlands, Spain
-
National Institute of General Medical Sciences...Completed
-
NYU Langone HealthCompletedMultiple Sclerosis | Chronic Pain | Neurological DisorderUnited States