N/A
Completed N=45
Virtual Reality System for Anxiety and OCD
Source: ClinicalTrials.gov NCT03636022 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 — -3.7; -3.6 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1 |
-3.7; -3.6 | — |
| PRIMARY Maximum SUDS Rating During Crossover Exposure |
2.1; 2.5 | — |
| SECONDARY Homework Engagement |
5.4; 5.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03636022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.