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Emotional RegulationVERVENCT05022550

Virtual-reality and Emotion Regulation in Violence-Exposed Youth

A study testing DEEP VR in people with Emotional Regulation and Adolescent Behavior, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Emotional Regulation, Adolescent Behavior
What is being tested?
DEEP VR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
3 Jun 2022to 1 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 13 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

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.

Read the detailed description

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.
Being tested
DEEP VR
Medical subject headings
Emotional Regulation, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEEP VRDevice

    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.

Study groups in NCT05022550
Study groupRoleWhat they receive
DEEP VR Experiment GroupExperimentalParticipants 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.
Receives: Device: DEEP VR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey

    Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".

    Measured: up to 8 weeks

Secondary outcomes (6)
  1. Mean Change in Difficulty in Emotion Regulation Scale (DERS)

    The DERS is a 36-item child-report survey measuring difficulties with emotion regulation. Respondents report the degree to which the given statement applied to them on a five point Likert scale: 1 = Almost Never to 5 = Always, with a possible total score range of 36 - 180. Higher scores indicate greater difficulties with emotion regulation.

    Measured: Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.

  2. Physiological Arousal Measured by Change in Heart Rate

    Participants will have electrodes affixed to their abdomen to measure heart rate. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions.

    Measured: Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period

  3. Physiological Arousal Measured by Change in Galvanic Skin Response

    Participants will have electrodes affixed to their fingers to measure skin response. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions.

    Measured: Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period

  4. Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale

    The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Positive sub-scale is the sum of positive items in the VR-B engagement survey (total range of scores from 4-28). Positive change scores indicate that the VR experience got more positive over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline).

    Measured: Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.

  5. Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale

    The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Negative sub-scale is the sum of negative items in the VR-B engagement survey (total possible range of scores from 4-28). Positive change scores indicate that the VR experience got less negative over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline).

    Measured: Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.

  6. Mean Change in Child PTSD Symptom Scale (CPSS)

    Assesses lifetime trauma experiences and severity of PTSD symptom severity in a 20-item survey scored on a 5-point likert scale from 0 'not at all' to 4 'almost always' for a total range of scores between 0 - 80, where higher scores indicate increased PTSD symptoms.

    Measured: Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start3 Jun 2022
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022550
Sponsor's protocol ID
2021-0185
Other IDs
Protocol Version 9/19/2025, SMPH/PSYCHIATRY/PSYCHIATRY, A538900
Acronym
VERVE
Status last verified
Jun 2026
First submitted
19 Aug 2021
Last updated
1 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Information to be shared may include questionnaire responses, physiological recordings, or game play data. These data will be coded with the unique subject ID, and will not include any linking protected health information or other identifiable information. Data will be shared via encrypted, password protected cloud storage (Box.com).

Publications

  • 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.

    PubMed 8379556
  • 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

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

    PubMed 29376669
  • 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.

    PubMed 32847397
  • 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.

    PubMed 22300910
  • 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.

    PubMed 17485609
  • 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.

    PubMed 31616353

Questions about this trial

What is this clinical trial studying?

A study testing DEEP VR in people with Emotional Regulation and Adolescent Behavior, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022550, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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