Virtual-reality and Emotion Regulation in Violence-Exposed Youth

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05022550

Acronym

VERVE

Enrollment

Registered

2021-08-26

Start date

2022-06-03

Completion date

2025-05-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Emotional Regulation

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.

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.

Interventions

DEVICEDEEP 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey	up to 8 weeks	Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable".

Secondary

Measure	Time frame	Description
Mean Change in Difficulty in Emotion Regulation Scale (DERS)	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.	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.
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, sessions typically occurred once a day, participating on 6 days within a 1-2 week period	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.
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, sessions typically occurred once a day, participating on 6 days within a 1-2 week period	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.
Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale	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.	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).
Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale	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.	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).
Mean Change in Child PTSD Symptom Scale (CPSS)	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.	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRyan J Herringa, MD,PhD

University of Wisconsin, Madison

PRINCIPAL_INVESTIGATORJustin D Russell, PhD