Virtual-reality and Emotion Regulation in Violence-Exposed Youth

NCT05022550 | Completed FDA Device

• 4 other identifiers: 2021-0185Protocol Version 9/19/2025SMPH/PSYCHIATRY/PSYCHIATRYA538900
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.

Conditions

Emotional Regulation; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Feasibility: Number of Participants who Enjoyed VR simulation experience: Determined via Qualitative Survey

  up to 8 weeks

Secondary Outcomes (5)

• Mean Change in Difficulty in Emotion Regulation Scale (DERS)

  Baseline and after each session completed for up to 6 study visits, up to 4 weeks

• Physiological Arousal Measured by Change in Heart Rate

  Change measured throughout the 15 minute VR session at baseline and before and after each task condition, for up to 6 sessions (up to 6 weeks on study)

• Physiological Arousal Measured by Change in Galvanic Skin Response

  Change measured throughout the 15 minute VR session at baseline and before and after each task condition, for up to 6 sessions (up to 6 weeks on study)

• Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B)

  Baseline and up to 4 weeks

• Mean Change in Child PTSD Symptom Scale (CPSS)

  Baseline and after each session completed for up to 6 study visits, up to 4 weeks

Study Arms (1)

DEEP VR Experiment Group

EXPERIMENTAL

Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires.

Device: DEEP VR

Interventions

DEEP VR DEVICE

DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt.

DEEP VR Experiment Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age at enrollment
• Availability of a caregiver to provide oral consent
• Able to provide assent/consent in English
• Visual acuity adequate to read text on a computer monitor

You may not qualify if:

• Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media
• Active psychosis or comparably impairing psychiatric condition

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Toronto: collaborator
• Radboud University Medical Center: collaborator
• Explore DEEP Inc: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (7)

• Warshaw MG, Fierman E, Pratt L, Hunt M, Yonkers KA, Massion AO, Keller MB. Quality of life and dissociation in anxiety disorder patients with histories of trauma or PTSD. Am J Psychiatry. 1993 Oct;150(10):1512-6. doi: 10.1176/ajp.150.10.1512.

  PMID: 8379556 BACKGROUND

• Zafar, M. A., Ahmed, B., Rihawi, R. A., & Gutierrez-Osuna, R. (2020). Gaming Away Stress: Using Biofeedback Games to Learn Paced Breathing. IEEE Transactions on Affective Computing, 11(3), 519-531. https://doi.org/10.1109/TAFFC.2018.2816945

  BACKGROUND

• Rizzo AS, Koenig ST. Is clinical virtual reality ready for primetime? Neuropsychology. 2017 Nov;31(8):877-899. doi: 10.1037/neu0000405.

  PMID: 29376669 BACKGROUND

• Fonkoue IT, Hu Y, Jones T, Vemulapalli M, Sprick JD, Rothbaum B, Park J. Eight weeks of device-guided slow breathing decreases sympathetic nervous reactivity to stress in posttraumatic stress disorder. Am J Physiol Regul Integr Comp Physiol. 2020 Oct 1;319(4):R466-R475. doi: 10.1152/ajpregu.00079.2020. Epub 2020 Aug 26.

  PMID: 32847397 BACKGROUND

• Fang X, Brown DS, Florence CS, Mercy JA. The economic burden of child maltreatment in the United States and implications for prevention. Child Abuse Negl. 2012 Feb;36(2):156-65. doi: 10.1016/j.chiabu.2011.10.006. Epub 2012 Feb 1.

  PMID: 22300910 BACKGROUND

• Copeland WE, Keeler G, Angold A, Costello EJ. Traumatic events and posttraumatic stress in childhood. Arch Gen Psychiatry. 2007 May;64(5):577-84. doi: 10.1001/archpsyc.64.5.577.

  PMID: 17485609 BACKGROUND

• Blum J, Rockstroh C, Goritz AS. Heart Rate Variability Biofeedback Based on Slow-Paced Breathing With Immersive Virtual Reality Nature Scenery. Front Psychol. 2019 Sep 20;10:2172. doi: 10.3389/fpsyg.2019.02172. eCollection 2019.

  PMID: 31616353 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation; Adolescent Behavior

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Ryan J Herringa, MD,PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Justin D Russell, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: June 3, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately upon study start.
• Access Criteria: Information will only be shared with the following individuals with knowledge of the methodology and analyses in this intervention: Dr. Isabele Granic, University of Toronto Joanneke Weerdmeester, Radboud University Owen L. Harris, Explore DEEP Inc.

Locations

US (1)