What side effects are associated with this type of intervention?

Common treatments for emotional regulation using immersive VR technology, such as VR-based video games, generally have mild side effects. These can include motion sickness, dizziness, headaches, and eye strain due to prolonged use of VR headsets. Additionally, some users may experience temporary disorientation or nausea. It is important to monitor these symptoms and adjust the duration and intensity of VR sessions accordingly.

What prior FDA approvals exist?

The FDA has approved various pharmacological treatments for emotional regulation, particularly for conditions like depression, anxiety, and PTSD. These include SSRIs (e.g., sertraline, fluoxetine), SNRIs (e.g., venlafaxine, duloxetine), and other medications like mirtazapine and propranolol. While immersive VR technology for emotional regulation is still under investigation, traditional treatments focus on pharmacotherapy and psychotherapy. VR-based treatments, such as the VR-B video game for emotional dysregulation in youth, represent a novel approach that is currently being studied but not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to VR-B video game treatments for emotional regulation include: 1) Neurofeedback, which uses real-time monitoring of brain activity to help patients learn to regulate their emotions. 2) Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve mood and emotional regulation. 3) Biofeedback, which involves using sensors to provide real-time feedback on physiological functions such as heart rate and muscle tension, helping patients learn to control these functions to manage stress and emotions. 4) Guided Imagery and Progressive Muscle Relaxation, which are mind-body techniques that help patients visualize calming scenarios and systematically relax muscle groups to reduce stress and improve emotional regulation.

← Back to Search

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

Summary

This trial will test a new VR-based video game treatment for emotional dysregulation in youth under juvenile justice supervision. 40 participants will be enrolled and asked to complete up to 6 VR-B sessions.

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.Check my eligibility

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.See study design

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 below

Select...

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 more

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.

0 / 2Eligibility criteria met

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.