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Recruiting NCT07219355

Virtual Reality Lethal Means Safety Training

No phase Interventional Suicide, Attempted Suicide, Completed Suicide Prevention Mental Health Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Lethal Means Safety Training, 2D Video Training.
Who it may be relevant to
Registry conditions: Suicide, Attempted, Suicide, Completed, Suicide Prevention, Mental Health Training. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Expanding Provider Capacity to Prevent Rural Veteran Suicide: Virtual Reality Lethal Means Safety Training

Overview

The goal of this randomized clinical trial is to determine whether a virtual reality (VR) training program can help healthcare providers improve their skills in discussing suicide prevention and safe storage of firearms and medications with Veterans. The study will test whether VR training increases providers' self-efficacy, confidence, and comfort in conducting lethal means safety counseling, and whether it improves their intention to use these counseling practices in their clinical work. Researchers will compare healthcare providers who complete the VR training to those who complete a 2D video training to determine whether the VR approach is more effective. Participants will complete online surveys before and after the training and again three months later. They will be randomly assigned to one of two groups: VR training group: Participants use a VR headset to interact with a virtual Veteran patient in a simulated rural clinic and practice suicide prevention counseling skills; Video training group: Participants use the same headset to watch a \~10-minute 2D video depicting the lethal means safety counseling session. After the training, participants will also provide feedback about their experience, including how realistic and useful they found the training.

Detailed description

This study will test whether a virtual reality (VR) training program can improve healthcare providers' ability to talk with Veterans about suicide prevention and safe storage of firearms and medications. Rural Veterans have suicide rates much higher than the national average, and providers in rural areas often do not receive enough training in suicide risk identification or lethal means safety counseling.

This project builds on our prior Veteran Suicide Assessment in Virtual Reality (VET-SAVR) study, which showed that VR can be a feasible and acceptable way to deliver suicide prevention training. In the current study, called the Virtual Reality Lethal Means Safety Training (VR-LMST) project, we will compare an immersive VR training simulation to a 2D video training.

Study Aims

Aim 1: Develop a VR training simulation focused on suicide prevention counseling with rural Veterans.

Aim 2: Test whether VR-LMST improves provider confidence (primary), and comfortability and intention (secondary) to engage in lethal means safety counseling.

Aim 3: Assess user experience of the VR simulation, including presence, realism, acceptability, feasibility, and tolerability.

Study Design

This is a randomized controlled trial. Participants will be assigned to one of two groups:

VR-LMST group: Participants will use a VR headset (Meta Quest 3) to enter a simulated rural clinic visit with a Veteran avatar who presents with thoughts of suicide. They will practice counseling skills related to safe firearm and medication storage.

2D Video group: Participants will use a VR headset to view a 10-minute video showing a provider having a lethal means safety conversation with a Veteran.

Assessments

Pre-test, post-test, and 3-month follow-up surveys will be completed online.

The Counseling on Access to Lethal Means (CALM) Core Scale (13 items) will measure provider confidence (1-5), comfortability (6-8), and intentions (9-13). An additional two items measure counseling behavior at 3 months (14-15).

The ITC-Sense of Presence Inventory (ITC-SOPI) will measure presence, naturalness, engagement, and negative effects.

Open-ended questions will gather feedback about realism, acceptability, and feasibility.

Demographic and professional background information will also be collected.

Sample Size and Timeline We will recruit 36 participants (18 per group). Power analysis indicates this sample size is sufficient to detect moderate effects with 80% power for the primary outcome.

Phase 1 (completed): Recruited 11 healthcare providers for qualitative interviews; conducted coding and analysis; developed and refined VR and 2D scripts.

Phase 2 (completed): Prototype VR clinic environment developed through iterative meetings with VR developers.

Phase 3 (completed): Pilot playtesting in October 2025 with 5 participants.

Phase 4 (planned): Randomized trial enrollment to begin mid-November 2025.

Phase 5 (planned): 3-month follow-ups to begin January 2026.

Oversight IRB approval was received September 27, 2024, from the University of Texas at Arlington. This study is funded by the American Foundation for Suicide Prevention (AFSP).

Significance This project will test a novel, scalable training method to give allied healthcare providers repeated opportunities to practice suicide prevention counseling in a safe environment. By equipping rural providers with the skills and confidence to have culturally sensitive, Veteran-centered conversations about firearm and medication safety, VR-LMST has the potential to improve clinical practice and reduce suicide risk among rural Veterans.

Interventions

  • Behavioral Virtual Reality Lethal Means Safety Training
    An immersive behavioral training program delivered through a Meta Quest 3 virtual reality headset. Participants enter a simulated rural health clinic and interact with a Veteran avatar at risk for suicide. The simulation incorporates realistic dialogue and decision points where providers practice skills in suicide risk identification, lethal means safety counseling (firearm and medication storage), and collaborative safety planning. The VR format allows repeated practice in a safe environment an
  • Behavioral 2D Video Training
    A 10-minute video delivered through a VR headset that depicts a healthcare provider conducting lethal means safety counseling with a Veteran. This is a non-interactive training used as an active comparator.

Primary outcome measures

  • Confidence in Lethal Means Safety Counseling [Time frame: Baseline (pre-test), immediately after intervention (post-test), and 3-month follow-up]
Secondary outcome measures (6)
  • Comfortability in Lethal Means Safety Counseling [Time frame: Baseline (pre-test), immediately after intervention (post-test), and 3-month follow-up]
  • Counseling Intentions [Time frame: Baseline (pre-test), immediately after intervention (post-test), and 3-month follow-up]
  • Spatial Presence [Time frame: Immediately after intervention (post-test only)]
  • Engagement [Time frame: Immediately after intervention (post-test only)]
  • Ecological Validity / Naturalness [Time frame: Immediately after intervention (post-test only)]
  • Negative Effects (Tolerability) [Time frame: Immediately after intervention (post-test only)]

Eligibility criteria

Inclusion criteria

  • Age 18 or older
  • healthcare providers serving rural Veterans in Texas (e.g., physicians, physician assistants, nurse practitioners, nurses, pharmacists, social workers, healthcare case managers)
  • English-speaking
  • Able to provide informed consent

Exclusion criteria

  • Self-reported pregnancy
  • History of motor or balance disorders
  • Color blindness
  • Neurological or cognitive disorders
  • Cardiovascular issues that may be worsened by VR use
  • Use of cardiac pacemakers, defibrillators, or hearing aids incompatible with VR equipment
  • Significant discomfort in virtual reality environments (e.g., severe motion sickness, vertigo)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Texas at Arlington — Arlington

Publications

  • Sale E, Hendricks M, Weil V, Miller C, Perkins S, McCudden S. Counseling on Access to Lethal Means (CALM): An Evaluation of a Suicide Prevention Means Restriction Training Program for Mental Health Providers. Community Ment Health J. 2018 Apr;54(3):293-301. doi: 10.1007/s10597-017-0190-z. Epub 2017 Nov 28. PMID 29185154
  • Hunter AA, DiVietro S, Boyer M, Burnham K, Chenard D, Rogers SC. The practice of lethal means restriction counseling in US emergency departments to reduce suicide risk: a systematic review of the literature. Inj Epidemiol. 2021 Sep 13;8(Suppl 1):54. doi: 10.1186/s40621-021-00347-5. PMID 34517912
  • Hoyt T, Holliday R, Simonetti JA, Monteith LL. Firearm Lethal Means Safety with Military Personnel and Veterans: Overcoming Barriers using a Collaborative Approach. Prof Psychol Res Pr. 2021 Aug;52(4):387-395. doi: 10.1037/pro0000372. Epub 2021 May 20. PMID 34421193
  • Diurba S, Johnson RL, Siry BJ, Knoepke CE, Suresh K, Simpson SA, Azrael D, Ranney ML, Wintemute GJ, Betz ME. Lethal Means Assessment and Counseling in the Emergency Department: Differences by Provider Type and Personal Home Firearms. Suicide Life Threat Behav. 2020 Oct;50(5):1054-1064. doi: 10.1111/sltb.12649. Epub 2020 Jun 29. PMID 32598076
  • Boggs JM, Quintana LM, Powers JD, Hochberg S, Beck A. Frequency of Clinicians' Assessments for Access to Lethal Means in Persons at Risk for Suicide. Arch Suicide Res. 2022 Jan-Mar;26(1):127-136. doi: 10.1080/13811118.2020.1761917. Epub 2020 May 7. PMID 32379012

Identifiers

NCT: NCT07219355 · 2024-0085 · ECR-0-140-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗