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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

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
Select...
I can read text on a computer screen clearly.
Select...
I am between 13 and 17 years old.

VERVE Trial 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)
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,169 Previous Clinical Trials
3,010,841 Total Patients Enrolled
1 Trials studying Emotional Regulation
48 Patients Enrolled for Emotional Regulation
University of TorontoOTHER
685 Previous Clinical Trials
1,018,120 Total Patients Enrolled
Radboud University Medical CenterOTHER
1,136 Previous Clinical Trials
675,899 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
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~8 spots leftby Jun 2024