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Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713516
Enrollment
40
Registered
2016-03-18
Start date
2017-08-01
Completion date
2018-05-31
Last updated
2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Obsessive Compulsive Disorder

Keywords

Anxiety, OCD, Obsessive Compulsive Disorder, Generalized Anxiety, Social Phobia, Separation Anxiety, GAD, Youth, Teen, Therapy

Brief summary

Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality exposures and to make therapy more available and accessible for patients with anxiety disorders. The societal benefit of increased access to therapy is that, if successful, it will increase the number of patients who receive appropriate treatment for an anxiety disorder.

Detailed description

Twenty children with CADs or OCD who have received less than 3 treatment sessions and a parent will be recruited to pilot the VR system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic. Each patient will participate in a single (up to) 2-hour visit. During the first 30 minutes the patient and parent will be introduced to the VR system and the rationale for this feasibility study. Next, a therapist will lead the patient through exposure exercises using the VR 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 VR system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the VR system. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the VR system and then will ask for observations and opinions from the parent.

Interventions

OTHERVirtual Reality

Use of virtual reality to deliver exposure therapy

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 7 to 12 2. Primary diagnosis of anxiety, generalized anxiety disorder, social phobia, separation anxiety and/or OCD

Exclusion criteria

1. History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder. 2. Current suicidality or recent suicidal behavior 3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties 4. Starting or changing the dosage of a psychiatric medication in the last 2 months

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of sessionapproximately 2 hoursThe SUDS - 0 to 10 ratings, where 0 indicates that they feel no anxiety at all and 10 indicates that they are experiencing maximum distress

Secondary

MeasureTime frameDescription
Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviewsapproximately 2 hoursThe ease of use of the VR system

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026