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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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. 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.
Device: Brief Violence Intervention VR (BVI-VR)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Violence

Clinical Trials on Treatment as Usual (TAU)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings