Clinical trial NCT02713516: Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD
Official title: Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Obsessive Compulsive Disorder
Keywords: Anxiety
OCD
Obsessive Compulsive Disorder
Generalized Anxiety
Social Phobia
Separation Anxiety
GAD
Youth
Teen
Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in Subjective Units of Distress Scale (SUDS) at end of session
timeFrame: approximately 2 hours
Secondary outcomes:
measure: Percent of children to describe the virtual reality system as engaging and easy to use based on qualitative interviews
timeFrame: approximately 2 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen P Whiteside, PhD., L.P.
role: PRINCIPAL_INVESTIGATOR
References: