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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

VERVE Trial 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.

VERVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can read text on a computer screen clearly.

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I am between 13 and 17 years old.

VERVE Trial 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

VERVE 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

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,411 Total Patients Enrolled

1 Trials studying Emotional Regulation

48 Patients Enrolled for Emotional Regulation

University of TorontoOTHER

690 Previous Clinical Trials

1,019,508 Total Patients Enrolled

Radboud University Medical CenterOTHER

1,150 Previous Clinical Trials

1,007,752 Total Patients Enrolled

Media Library

DEEP VR (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05022550 — N/A

Emotional Regulation Research Study Groups: DEEP VR Experiment Group

Emotional Regulation Clinical Trial 2023: DEEP VR Highlights & Side Effects. Trial Name: NCT05022550 — N/A

DEEP VR (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05022550 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are participants engaging in this medical research?

"Affirmative, the information available on clinicaltrials.gov indicates that this research is actively recruiting participants. This trial was published in June of 2022 and has since been updated once in July. It seeks to recruit 40 people from a single site."

Answered by AI

Could I be admitted to take part in this clinical trial?

"This research is searching for 40 minors with moral injury between the ages of 13 and 17. Those interested must meet these requirements to be eligible."

Answered by AI

What end results are researchers hoping to uncover in this clinical research?

"The primary objective of this medical trial, which will be monitored from Baseline to 6 weeks post-study day 6, is assessing the feasibility of participants enjoying a virtual reality simulation experience through qualitative survey. Secondary outcomes comprise Mean Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) - Child Report, Mood and Feelings Questionnaire (MFQ) - Parent Report, and Childhood Trauma Questionnaire (CTQ). The respective score ranges span 0-80, 0-66, and 0-112 with higher scores signifying more severe symptoms/increased frequency of traumatic experiences."

Answered by AI

Is the participant cohort in this trial restricted by age?

"As per the rules of this medical trial, enrollees must be between 13 and 17 years old."

Answered by AI

Is there availability in this clinical trial for prospective participants?

"Correct. According to clinicaltrials.gov, this medicine study is actively recruiting patients and was initially posted on June 3rd 2022. Currently, 40 participants are needed from 1 medical facility before the trial can begin in earnest."

Answered by AI

Recent research and studies

Archives of General PsychiatryJournal

Traumatic Events and Posttraumatic Stress in Childhood

Copeland, William E., Gordon Keeler, Adrian Angold, and E. Jane Costello. 2007. “Traumatic Events and Posttraumatic Stress in Childhood”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.64.5.577.

American Journal of PsychiatryJournal

Quality of Life and Dissociation in Anxiety Disorder Patients with Histories of Trauma or PTSD

“Quality of Life and Dissociation in Anxiety Disorder Patients with Histories of Trauma or PTSD”. 1993. “Quality of Life and Dissociation in Anxiety Disorder Patients with Histories of Trauma or PTSD”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.150.10.1512.

American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyJournal

Eight Weeks of Device-guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Posttraumatic Stress Disorder

Fonkoue, Ida T., Yingtian Hu, Toure Jones, Monica Vemulapalli, Justin D. Sprick, Barbara Rothbaum, and Jeanie Park. 2020. “Eight Weeks of Device-guided Slow Breathing Decreases Sympathetic Nervous Reactivity to Stress in Posttraumatic Stress Disorder”. American Journal of Physiology-regulatory, Integrative and Comparative Physiology. American Physiological Society. doi:10.1152/ajpregu.00079.2020.

Child Abuse & NeglectJournal