- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06239285
A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults
June 6, 2025 updated by: Virginia Commonwealth University
The overall aim of the proposed project is to develop and evaluate the effectiveness of Brief Violence Intervention-Virtual Reality (BVI-VR) for reducing firearm-related violence, re-injury, and mortality among victims of violence.
Outcome measures of firearm-related violence will come from multiple sources, including criminal background checks, hospital data, state-level data, semi-structured clinical assessments, and self-report assessments.
In addition, the study aims to understand the impact of BVI-VR on psychosocial mediators resulting in a reduction of firearm-related violence.
This will include self-report surveys, neurocognitive assessments, and clinical assessments.
The economic efficiency of BVI-VR as a firearm-related violence intervention will also evaluated.
To achieve these aims, a randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health will be conducted.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Brief Violence Intervention-Virtual Reality (BVI-VR) is being developed as a hospital-based brief gun violence intervention program founded on the principles of positive psychology, motivational goal setting (via gameplay), psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy.
This proposal will develop five steps to create a 30-minute brief firearm-related violence intervention.
The five steps address a range of psychosocial risk factors and enhance protective factors for violence, as well as psychoeducational programming specifically addressing the risk of firearm violence.
All steps of the BVI-VR emphasize being in control of making positive choices, and how to locate and leverage opportunities within their communities to improve their well-being.
BVI-VR empowers patients to be the driver of their well-being.
Study Type
Interventional
Enrollment (Estimated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicholas Thomson
- Phone Number: (804) 297-5740
- Email: Nicholas.thomson@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 232398
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Nicholas Thomson
- Phone Number: 804-297-5740
- Email: nicholas.thomson@vcuhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- violently injured patients from VCU's Level 1 Trauma Center
- 18 years or older
- English-speaking
Exclusion Criteria:
- Under 18 years old
- Not a victim of Violent crime
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Treatment as Usual (TAU) Group
The treatment-as-usual (TAU) group will receive a community resource brochure (the same one that is provided at the end of BVI-VR).
This brochure provides contact detail for services in the local area.
|
group will receive a community resource brochure (the same one that is provided at the end of BVI-VR).
This brochure provides contact detail for services in the local area.
These include organizations that provide mental health counseling, mentorship services, career development programs, organized community activities and sports, educational support, financial support, substance abuse programs, and resource assistance (e.g., food, housing, etc.).
|
|
Experimental: Intervention Group
Patients randomized into the BVI-VR group will answer questions about the session content and the rationale for the content.
Their responses will provide an estimate of engagement providing a better understanding of treatment fidelity.
|
BVI-VR is being developed as a hospital-based brief gun violence intervention program founded on the principles of positive psychology, motivational goal setting (via gameplay), psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy.
All steps of the BVI-VR emphasize being in control of making positive choices, and how to locate and leverage opportunities within their communities to improve their well-being.
BVI-VR empowers patients to be the driver of their well-being
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Firearm-related violence /The gun violence questionnaire
Time Frame: Baseline self-report, 3- and 6-months post-randomization
|
The gun violence questionnaire is a 9-item self-report that assesses firearm-related violence.
Items were adapted from the Buss-Perry Aggression Questionnaire physical aggression scale; for example, "Given enough provocation, I may fire my gun at another person".
The measure has adequate internal consistency (α = .75)
and good convergent and discriminant validity with other violence related measures
|
Baseline self-report, 3- and 6-months post-randomization
|
|
Gun Behaviors and Beliefs Scale
Time Frame: 3 and 6 month post baseline
|
Gun Behaviors and Beliefs Scale will be used to measure gun behaviors and beliefs that may be impacted by the intervention: Safety and Control, Social Perceptions, Emotional Risk, Common Beliefs.
The subscales have demonstrated adequate to good internal consistency (α = .79-.96).
|
3 and 6 month post baseline
|
|
Firearm criminal conviction and arrests/ Criminal Background Checks
Time Frame: prior to baseline assessment, from baseline to 3-month follow-up, and from 3-month follow-up to the 6-month follow-up.
|
Criminal background checks will be conducted on participants to assess violent criminal arrests and gun-related crimes and police contacts.
Criminal activity will be coded for the occurrence of nonviolent crime, violent crime, and firearm-related crime for three-time points: prior to baseline assessment, from baseline to 3-month follow-up, and from 3-month follow-up to the 6-month follow-up.
|
prior to baseline assessment, from baseline to 3-month follow-up, and from 3-month follow-up to the 6-month follow-up.
|
|
Non-convicted firearm-related violent crime/ Violent Crime Assessment
Time Frame: 3 and 6 month post baseline
|
Violent Crime Assessment is a semi-structured clinical assessment of convicted and non-convicted violent crime.
The measure captures six categories of violent crimes that participants have and have not been arrested for; simple assault, aggravated assault, homicide, robbery, rape, and sexual assault.
Information is collected on weapon use for each of the crimes (e.g., used a firearm during rape; fired a gun at a party and may have hit someone).
The VCA provides a valuable index for firearm-related violence that is not captured in self-report measures or criminal background checks.
|
3 and 6 month post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Firearm-related re-injury/ Self-report
Time Frame: 3 and 6 month post baseline
|
Violent injury data are collected from self-report surveys which capture the number of times a participant has been violently injured and what the patient was injured by (GSW).
|
3 and 6 month post baseline
|
|
Firearm-related re-injury/ Hospital data: Virginia Department of Health
Time Frame: 3 and 6 month post baseline
|
Violent injury data are collected from VCU's hospital database.
|
3 and 6 month post baseline
|
|
Firearm-related mortality/ Hospital data; Virginia Department of Health; National Death Index
Time Frame: 3 and 6 month post baseline
|
Mortality rates will be collected from hospital records and the National Death Index database.
|
3 and 6 month post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas Thomson, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
January 26, 2024
First Submitted That Met QC Criteria
January 26, 2024
First Posted (Actual)
February 2, 2024
Study Record Updates
Last Update Posted (Actual)
June 8, 2025
Last Update Submitted That Met QC Criteria
June 6, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HM20027823_Thomson
- R01CE003625 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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