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Behavioural Intervention
Virtual Reality Therapy for Emotional Regulation in Youth (VERVE Trial)
N/A
Recruiting
Led By Ryan J Herringa, MD,PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Visual acuity adequate to read text on a computer monitor
13 to 17 years of age at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test virtual reality video games as a way to help young people in the juvenile justice system manage their emotions. The games provide real-time feedback on the body's responses, teaching better emotional control. The goal is to see if this method is effective and well-received by the participants.
Who is the study for?
This trial is for youth aged 13-17 under juvenile justice supervision, who can read English and have a caregiver's consent. It's not for those with severe psychiatric conditions or discomfort with immersive experiences like VR.
What is being tested?
The study tests a virtual reality video game designed to help manage emotions in teens exposed to violence. Participants will undergo up to six sessions of the VR-based treatment called DEEP VR.
What are the potential side effects?
Since this intervention involves virtual reality, potential side effects may include temporary discomfort such as dizziness, nausea, or eye strain from using the VR equipment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can read text on a computer screen clearly.
Select...
I am between 13 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Mean Change in Child PTSD Symptom Scale (CPSS)
Mean Change in Difficulty in Emotion Regulation Scale (DERS)
Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DEEP VR Experiment GroupExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for emotional regulation, such as Virtual-Reality-Based (VR-B) video game therapy, work by immersing patients in controlled, interactive environments that simulate real-life scenarios. This immersive experience allows patients to practice coping strategies and emotional responses in a safe and controlled setting.
The key mechanism is the engagement of the brain's emotional and cognitive pathways through realistic simulations, which helps in desensitizing triggers and improving emotional control. This matters for emotional regulation patients as it provides a practical and engaging way to develop and reinforce healthy emotional responses, potentially leading to better management of emotional dysregulation in real-world situations.
A Randomised Controlled Comparison of Second-Level Treatment Approaches for Treatment-Resistant Adults with Bulimia Nervosa and Binge Eating Disorder: Assessing the Benefits of Virtual Reality Cue Exposure Therapy.
A Randomised Controlled Comparison of Second-Level Treatment Approaches for Treatment-Resistant Adults with Bulimia Nervosa and Binge Eating Disorder: Assessing the Benefits of Virtual Reality Cue Exposure Therapy.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,864 Total Patients Enrolled
1 Trials studying Emotional Regulation
48 Patients Enrolled for Emotional Regulation
University of TorontoOTHER
725 Previous Clinical Trials
1,115,561 Total Patients Enrolled
Radboud University Medical CenterOTHER
1,190 Previous Clinical Trials
1,154,159 Total Patients Enrolled
Explore DEEP IncUNKNOWN
Ryan J Herringa, MD,PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read text on a computer screen clearly.I am between 13 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: DEEP VR Experiment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.