Virtual Reality Therapy for Emotional Regulation in Youth

(VERVE Trial)

Overseen by Ryan J Herringa, MD,PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Active psychosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment DEEP VR, DEEP-VR, Virtual Reality Game for Anxiety and Depression?

Research shows that virtual reality (VR) therapies can help reduce symptoms of anxiety and depression. A meta-analysis found VR therapies to be more effective than control conditions for these issues, and VR has been shown to be a practical and effective tool in treating social anxiety and aggressive behavior in children. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating emotional disorders in youth?

Virtual reality therapy is generally considered safe for treating emotional disorders, with studies showing it to be feasible and tolerable for youth with anxiety. Some mild and temporary side effects like nausea, dizziness, or headache may occur, but these are not common. ^{1 5 6 7 8}

How does the treatment DEEP VR differ from other treatments for emotional regulation in youth?

DEEP VR is unique because it uses immersive virtual reality to help young people manage their emotions, offering a playful and engaging way to practice emotional regulation. Unlike traditional therapies, it provides a scalable and accessible solution that can be used remotely, making it easier for youth to access treatment. ^{1 2 4 5 6}

Research Team

Ryan J Herringa, MD,PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

I can read text on a computer screen clearly.

Availability of a caregiver to provide oral consent

I am between 13 and 17 years old.

Exclusion Criteria

Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media

Active psychosis or comparably impairing psychiatric condition

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo up to 6 virtual-reality-based biofeedback sessions to improve emotional regulation

6 weeks

Up to 6 visits (in-person)

Follow-up

Participants are monitored for changes in physiological arousal and symptom severity after treatment

4 weeks

Treatment Details

Interventions

• DEEP VR (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: DEEP VR Experiment Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Allison Brown

University of Toronto

Chief Medical Officer

PhD in Chemical Engineering from the University of Toronto

Michael Sefton

University of Toronto

Chief Executive Officer since 2017

PhD in Chemical Engineering from the University of Toronto and MIT

Radboud University Medical Center

Collaborator

Trials

1,203

Recruited

1,157,000+

Jacques Lemmens

Radboud University Medical Center

Chief Executive Officer since 2020

PhD in Organic Chemistry, University of Nijmegen

Louis Denis

Radboud University Medical Center

Chief Medical Officer

MD, Vrije Universiteit Brussel

Explore DEEP Inc

Collaborator

Trials

1

Recruited

140+

Findings from Research

Immersive virtual reality (VR) exposures are feasible and show clinical benefits in reducing anxiety severity in youth with specific phobias, based on a study involving three youth and their parents who underwent a one-session treatment.

The use of VR exposures resulted in significant changes in both physiological arousal and subjective distress, with evidence of physiological habituation observed in participants who responded positively to the treatment at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. Ramsey, KA., Essoe, JK., Boyle, N., et al.[2023]

In a study involving 115 boys with aggressive behavior problems, using interactive virtual reality alongside Cognitive Behavioral Therapy (CBT) significantly reduced aggressive behaviors compared to standard care and traditional roleplays.

The virtual reality approach not only improved treatment outcomes but also enhanced children's emotional engagement and overall appreciation of the therapy, suggesting it could be a valuable tool in behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. Alsem, SC., van Dijk, A., Verhulp, EE., et al.[2023]

Virtual reality (VR) exposure therapy integrated into cognitive-behavioral therapy (CBT) for social anxiety disorder (SAD) was found to be more effective than traditional in-person exposure, with significant improvements on the Liebowitz Social Anxiety Scale and other measures.

The study involved 59 participants over 14 weekly CBT sessions, and results showed that VR exposure not only led to better outcomes immediately after treatment but also maintained improvements at a 6-month follow-up, while being more practical for therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. Bouchard, S., Dumoulin, S., Robillard, G., et al.[2019]

Virtual reality (VR) shows promise as an effective assessment and treatment tool for anxiety disorders, including post-traumatic stress disorder and obsessive-compulsive disorder, but its use in clinical practice remains limited despite rapid advancements in technology.

VR is particularly appealing for younger patients due to its engaging and playful elements, which may facilitate treatment and preventive interventions, highlighting the need for further research and integration into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. Meyerbröker, K., Morina, N.[2021]

Virtual reality (VR) interventions significantly reduced anxiety (effect size g = 0.79) and depression (effect size g = 0.73) compared to control conditions in a meta-analysis of 39 trials involving various psychological interventions.

Despite the effectiveness of VR therapies for anxiety and depression, they did not significantly reduce treatment attrition rates, indicating that while VR can help with symptoms, it may not keep participants engaged in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality based interventions for symptoms of anxiety and depression: A meta-analysis. Fodor, LA., Coteț, CD., Cuijpers, P., et al.[2019]

Virtual reality interventions have shown large treatment effects and are considered effective for various anxiety disorders and post-traumatic stress disorder, particularly when used in cognitive behavioral therapy.

There is significant variability in the implementation of these interventions, including cost and technology used, which may affect their translation from research to clinical practice; future studies should focus on improving methodology and exploring their use for other emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Decade in Review: A Systematic Review of Virtual Reality Interventions for Emotional Disorders. Rowland, DP., Casey, LM., Ganapathy, A., et al.[2023]

Virtual Reality Based Exposure Therapy (VRBET) showed positive effects in treating agoraphobia in a trial with 10 participants, indicating its potential as an effective standalone treatment.

Combining VRBET with cognitive therapy did not result in significant improvements over VRBET alone, suggesting that VRBET may be sufficient for addressing agoraphobia without the need for additional cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. Malbos, E., Rapee, RM., Kavakli, M.[2011]

Virtual reality exposure therapy (VRET) has emerged as a promising alternative for treating anxiety disorders, particularly in cases where traditional imaginal exposure therapy is challenging to implement, allowing for controlled exposure to phobic stimuli in a safe environment.

High levels of 'immersion' and 'presence' during VRET are linked to better therapeutic outcomes, enabling therapists to tailor exposure intensity to individual patient needs, although the technology requires specialized training and can have mild side effects like nausea or dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. Mitrousia, V., Giotakos, O.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The use of virtual reality in assessment and treatment of anxiety and related disorders. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality based interventions for symptoms of anxiety and depression: A meta-analysis. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

A Decade in Review: A Systematic Review of Virtual Reality Interventions for Emotional Disorders. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]

8. Greece pubmed.ncbi.nlm.nih.gov

[Virtual reality therapy in anxiety disorders]. [2017]