Virtual-reality and Emotion Regulation in Violence-Exposed Youth

NCT ID: NCT05022550

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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The goal of this proposal is to determine the feasibility of a novel virtual-reality-based biofeedback (VR-B) treatment among youth highly vulnerable to difficulties in emotional regulation. Biofeedback, which involves the provision of real-time information about physiology, is a well-studied approach to enhancing self-regulatory ability, with potential promise for alleviating mental health problems. In children (as well as adults), biofeedback may be ideally facilitated through video game environments, which offer engaging, immersive, yet dynamic environments that can be changed in real-time. Video games are enormously popular with youth, and may represent an important avenue for treatment in adolescent populations. The current proposal aims to evaluate a novel virtual-reality-based video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. Exposure to risk factors known to promote impaired self-regulation, such as child mal-treatment, is nearly endemic in this population. Indeed, 'delinquent' youth (i.e., youth in contact with the justice system) are considerably more likely to meet diagnostic criteria for a range of disorders centrally involving dysregulation of affect or arousal, such as post-traumatic stress disorder, anxiety, depression, oppositional defiant disorder, and many others.

Specific Aims:

* AIM 1: Evaluate the feasibility of a virtual reality treatment for youth

* Hypothesis 1: Study youth receiving treatment with the virtual reality-based paradigm will qualitatively report the experience to be tolerable and positive with minimal discomfort.
* AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions

* Hypothesis 2: Youth receiving virtual reality biofeedback (VRB) treatment will exhibit physiological changes across sessions (e.g., increased heart rate variability or changes in skin conductance responses).
* AIM 3: Identify potential changes in symptom severity across treatment sessions

* Hypothesis 3: Youth receiving virtual reality biofeedback (VRB) treatment will show greater improvements in youth emotion regulation and reduced severity of PTSD mental health symptoms.

Conditions

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Emotional Regulation Adolescent Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DEEP VR Experiment Group

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.

Group Type EXPERIMENTAL

DEEP VR

Intervention Type 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.

Interventions

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DEEP VR

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 13 to 17 years of age at enrollment
2. Availability of a caregiver to provide oral consent
3. Able to provide assent/consent in English
4. Visual acuity adequate to read text on a computer monitor

Exclusion Criteria

1. Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media
2. Active psychosis or comparably impairing psychiatric condition
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Explore DEEP Inc

UNKNOWN

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan J Herringa, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Justin D Russell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8379556 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 29376669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32847397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22300910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17485609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31616353 (View on PubMed)

Other Identifiers

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Protocol Version 9/19/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/PSYCHIATRY/PSYCHIATRY

Identifier Type: OTHER

Identifier Source: secondary_id

A538900

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0185

Identifier Type: -

Identifier Source: org_study_id

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