[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07219355":3,"trial-entities:NCT07219355":130,"trial-summary:NCT07219355":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":33,"primary_purpose":14,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":49,"secondary_outcomes":54,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":93,"locations":96,"central_contacts":106,"overall_officials":107,"references":112,"see_also_links":129},"NCT07219355","2024-0085","Virtual Reality Lethal Means Safety Training","Expanding Provider Capacity to Prevent Rural Veteran Suicide: Virtual Reality Lethal Means Safety Training","ACTIVE_NOT_RECRUITING","2026-09-30","2026-08","2026-09-03","2026-02-23","The University of Texas at Arlington","OTHER",false,"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.","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.\n\nThis 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.\n\nStudy Aims\n\nAim 1: Develop a VR training simulation focused on suicide prevention counseling with rural Veterans.\n\nAim 2: Test whether VR-LMST improves provider confidence (primary), and comfortability and intention (secondary) to engage in lethal means safety counseling.\n\nAim 3: Assess user experience of the VR simulation, including presence, realism, acceptability, feasibility, and tolerability.\n\nStudy Design\n\nThis is a randomized controlled trial. Participants will be assigned to one of two groups:\n\nVR-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.\n\n2D 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.\n\nAssessments\n\nPre-test, post-test, and 3-month follow-up surveys will be completed online.\n\nThe 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).\n\nThe ITC-Sense of Presence Inventory (ITC-SOPI) will measure presence, naturalness, engagement, and negative effects.\n\nOpen-ended questions will gather feedback about realism, acceptability, and feasibility.\n\nDemographic and professional background information will also be collected.\n\nSample 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.\n\nPhase 1 (completed): Recruited 11 healthcare providers for qualitative interviews; conducted coding and analysis; developed and refined VR and 2D scripts.\n\nPhase 2 (completed): Prototype VR clinic environment developed through iterative meetings with VR developers.\n\nPhase 3 (completed): Pilot playtesting in October 2025 with 5 participants.\n\nPhase 4 (completed): Randomized trial enrollment to begin mid-November 2025.\n\nPhase 5 (in progress): 3-month follow-ups to begin January 2026.\n\nOversight 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).\n\nSignificance This project will test a novel, scalable training method to give 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.",[19,20,21,22,23,24],"Suicide, Attempted","Suicide, Completed","Suicide Prevention","Mental Health Training","Rural Health","Veterans",[24,26,21,27,28,29,30,31,32,23],"Rural Veterans","Suicide Risk","Firearm Safety","Medication Safety","Lethal Means Safety Counseling","Virtual Reality (VR)","VR Training Simulation","INTERVENTIONAL",[35],"NA",{"count":37,"type":38},36,"ESTIMATED",[40,45],{"type":41,"name":6,"description":42,"armGroupLabels":43},"BEHAVIORAL","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 and provides a more engaging and realistic training experience than traditional methods.",[44],"VR-LMST Intervention",{"type":41,"name":46,"description":47,"armGroupLabels":48},"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.",[46],[50],{"measure":51,"description":52,"timeFrame":53},"Confidence in Lethal Means Safety Counseling","Measured by the Counseling on Access to Lethal Means (CALM) Core Scale (Sale et al., 2018) Confidence subscale (\"How confident are you that …\"). Items are rated on a 4-point scale and summed; higher scores indicate greater confidence (range = 5 - 20).","Baseline (pre-test), immediately after intervention (post-test), and 3-month follow-up",[55,58,61,65,68,71],{"measure":56,"description":57,"timeFrame":53},"Comfortability in Lethal Means Safety Counseling","Measured by the Counseling on Access to Lethal Means (CALM) Core Scale (Sale et al., 2018) Comfortability subscale (\"How comfortable are you talking about …\"). Includes 3 items where 1 = Not Very Comfortable to 4 = Extremely Comfortable. Items are rated on a 4-point scale and summed (range = 3 - 12). Higher scores indicating greater comfort initiating suicide or means-restriction discussions.",{"measure":59,"description":60,"timeFrame":53},"Counseling Intentions","Measured by the Counseling on Access to Lethal Means (CALM) Core Scale (Sale et al., 2018) Counseling Intentions subscale (\"If you recognize warning signs of suicide in an individual, how likely are you to…\"). Includes 5 items where 1 = Not Very Likely to 4 = Extremely Likely. Items are rated on a 4-point scale and summed (range = 5-20). Higher scores indicate stronger intentions to engage in suicide-prevention and lethal-means safety counseling behaviors.",{"measure":62,"description":63,"timeFrame":64},"Spatial Presence","Measured by the ITC-Sense of Presence Inventory (Lessiter et al., 2001) Spatial Presence subscale (\"During my experience of the displayed environment…\"). Includes 19 items (e.g., \"I felt as though I was in the same space as the characters and\u002For objects\") rated on a 5-point scale where 1 = Strongly Disagree to 5 = Strongly Agree. Items are averaged to create a mean subscale score (range = 1 - 5). Higher scores indicate a stronger sense of \"being there\" or physical immersion within the virtual environment.","Immediately after intervention (post-test only)",{"measure":66,"description":67,"timeFrame":64},"Engagement","Measured by the ITC-Sense of Presence Inventory (Lessiter et al., 2001) Engagement subscale (\"During my experience of the displayed environment…\"). Includes 13 items (e.g., \"I felt myself being drawn in\") rated on a 5-point scale where 1 = Strongly Disagree to 5 = Strongly Agree. Items are averaged to create a mean subscale score (range = 1 - 5). Higher scores indicate greater emotional and cognitive involvement in the displayed environment.",{"measure":69,"description":70,"timeFrame":64},"Ecological Validity \u002F Naturalness","Measured by the ITC-Sense of Presence Inventory (Lessiter et al., 2001) Ecological Validity \u002F Naturalness subscale (\"During my experience of the displayed environment…\"). Includes 5 items (e.g., \"The scenes depicted could really occur in the real world\") rated on a 5-point scale where 1 = Strongly Disagree to 5 = Strongly Agree. Items are averaged to create a mean subscale score (range = 1 - 5). Higher scores indicate greater perceived realism and naturalness of the virtual environment.",{"measure":72,"description":73,"timeFrame":64},"Negative Effects (Tolerability)","Tolerability will be measured by the ITC-Sense of Presence Inventory (Lessiter et al., 2001) Negative Effects subscale (\"During my experience of the displayed environment…\"). Includes 6 items (e.g., \"I felt dizzy,\" \"I felt nauseous\") rated on a 5-point scale where 1 = Strongly Disagree to 5 = Strongly Agree. Items are averaged to create a mean subscale score (range = 1 - 5). Higher scores indicate greater discomfort or simulator-related side effects (e.g., dizziness, eyestrain, nausea) and thus, lower tolerability.","ALL","18 Years",null,true,{"inclusion":79,"exclusion":84,"raw_text":92},[80,81,82,83],"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",[85,86,87,88,89,90,91],"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)","Inclusion Criteria:\n\n* Age 18 or older\n* healthcare providers serving rural Veterans in Texas (e.g., physicians, physician assistants, nurse practitioners, nurses, pharmacists, social workers, healthcare case managers)\n* English-speaking\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Self-reported pregnancy\n* History of motor or balance disorders\n* Color blindness\n* Neurological or cognitive disorders\n* Cardiovascular issues that may be worsened by VR use\n* Use of cardiac pacemakers, defibrillators, or hearing aids incompatible with VR equipment\n* Significant discomfort in virtual reality environments (e.g., severe motion sickness, vertigo)",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"geoPoint":103},"University of Texas at Arlington","Arlington","Texas","76019","United States",{"lat":104,"lon":105},32.73569,-97.10807,[],[108],{"name":109,"affiliation":110,"role":111},"Donna L. Schuman, PhD, LCSW","University of Texas at Arlington, School of Social Work","PRINCIPAL_INVESTIGATOR",[113,117,120,123,126],{"pmid":114,"type":115,"citation":116},"29185154","BACKGROUND","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\u002Fs10597-017-0190-z. Epub 2017 Nov 28.",{"pmid":118,"type":115,"citation":119},"34517912","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\u002Fs40621-021-00347-5.",{"pmid":121,"type":115,"citation":122},"34421193","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\u002Fpro0000372. Epub 2021 May 20.",{"pmid":124,"type":115,"citation":125},"32598076","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\u002Fsltb.12649. Epub 2020 Jun 29.",{"pmid":127,"type":115,"citation":128},"32379012","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\u002F13811118.2020.1761917. Epub 2020 May 7.",[],{"nct_id":4,"conditions":131,"biomarkers":132},[21],[],{"nct_id":4,"found":77,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is a randomized controlled trial comparing two behavioral interventions. It plans to enroll 36 participants.","completed","Virtual Reality Training for Suicide Prevention in Rural Veterans","This study is testing if a virtual reality (VR) training program, called Virtual Reality Lethal Means Safety Training, can help healthcare providers better discuss suicide prevention and safe storage of firearms and medications with Veterans. You would be compared to participants who watch a 2D video training. The goal is to see if the VR training improves providers' confidence in counseling Veterans about these important topics. Researchers will measure your confidence right after training and again three months later. This study is for healthcare providers serving rural Veterans in Texas, aged 18 or older, who speak English. The study aims to enroll 36 participants, but its current status is unclear.","Your confidence will be measured at a 3-month follow-up after the intervention.",110,"You would complete online surveys before and after the training, and again three months later. The training itself involves either an immersive VR experience or a 10-minute video.","Not stated in the trial record.",[6,46],"v2"]