VA S.A.V.E. for Suicide Prevention

Overseen By Kaitlin M Leonard, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: No internet, Duplicate entry, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

710 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a training program called VA S.A.V.E., designed to help family and friends of Veterans identify signs of suicide risk and connect them to professional help. The study aims to evaluate the program's effectiveness and identify factors that might aid or hinder its broader use. Participants will either receive the VA S.A.V.E. training or attend a session on myths and facts about wounded warriors. This trial suits family members, caregivers, or friends who see a Veteran at least once a week and wish to learn how to support them better. As an unphased trial, this study offers a unique opportunity to contribute to important research that could significantly impact Veterans' well-being.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the VA S.A.V.E. training is safe for suicide prevention?

Research has shown that VA S.A.V.E. is a safe and easy-to-handle training program. This short educational tool helps people recognize and respond to signs of suicide risk in Veterans. Unlike medications, VA S.A.V.E. focuses on teaching skills and raising awareness. No reports of negative effects have emerged from this training, making it a low-risk choice for participants. The training aims to educate rather than medicate, typically involving fewer safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VA S.A.V.E. (Signs, Ask, Validate, Encourage and Expedite) approach because it introduces a unique and structured training method aimed at suicide prevention. Unlike traditional treatments that might focus on counseling or medication for individuals at risk, VA S.A.V.E. empowers people in the community, including veterans, to recognize warning signs and take immediate, supportive action. This method emphasizes community involvement and timely intervention, which could lead to faster and more widespread support for those in need. By enhancing awareness and providing practical steps for intervention, it has the potential to complement existing therapeutic approaches and create a broader safety net for individuals at risk.

What evidence suggests that VA S.A.V.E. is effective for suicide prevention?

Research shows that VA S.A.V.E. training, which participants in this trial may receive, helps family and friends recognize and respond to signs of suicide risk in veterans. Studies have found that this training can increase awareness and improve the ability to connect veterans with professional help. Early results suggest it is a promising way for those close to veterans to offer support and take quick action. This training aims to make a real difference by teaching important skills to prevent suicide among veterans. ^{2 5 6 7 8}

Who Is on the Research Team?

Alan R. Teo, MD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

This trial is for individuals who are in regular contact with a Veteran at least once a week, such as family members, caregivers, or friends. Participants must have internet access and provide valid contact information. Those who have already taken VA S.A.V.E. training or plan to take it soon cannot join.

Inclusion Criteria

Social contact with a Veteran at least once a week

Family member, caregiver, or friend of a Veteran

Exclusion Criteria

No internet access

Indication of duplicate study entry

I have completed or plan to complete VA S.A.V.E. training soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive VA S.A.V.E. training or watch an informational video as a control

1 session

1 visit (virtual)

Follow-up

Participants are monitored for the use of gatekeeper behaviors and suicide prevention skills

12 months

Surveys conducted at 3-month and 6-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• VA S.A.V.E.

Trial Overview

The study is testing the effectiveness of VA S.A.V.E., a suicide prevention program designed for the Veteran community. It compares how well people can help Veterans at risk of suicide after receiving this specific training versus standard control training.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

VA S.A.V.E. Training

Group II: Control Placebo Group 1 Intervention

Myths and Facts of Wounded Warriors

VA S.A.V.E. is already approved in United States for the following indications:

Approved in United States as VA S.A.V.E. for:

• Suicide prevention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The analysis of adverse events and near misses is crucial for improving patient safety, highlighting the importance of understanding the root causes of these incidents.

The diverse perspectives of participants in safety discussions can enhance the effectiveness of safety initiatives, as demonstrated by the VA Center for Patient Safety's leadership in the safety movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative patient safety program launched. [2004]

In a study of 31 patients with ruptured sinus of Valsalva aneurysm, a new surgical technique using patches for repair resulted in no recurrent ruptures or residual defects, demonstrating its efficacy and safety.

After surgery, 85% of the surviving patients were in the best functional class (NYHA Class I) at follow-up, with a long-term survival rate of 85.6% over 25 years, indicating excellent outcomes from this surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical repair and long-term results in ruptured sinus of Valsalva aneurysm. Abe, T., Komatsu, S.[2022]

The SAFE VET protocol aims to test a brief intervention that combines Safety Planning Intervention with structured follow-up to effectively reduce suicide risk among Veterans in emergency departments.

This study addresses a significant gap in evidence-based interventions for Veterans at risk of suicide, focusing on enhancing their engagement in outpatient behavioral health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and study protocol for a two-part intervention: Safety planning and structured follow-up among veterans at risk for suicide and discharged from the emergency department. Currier, GW., Brown, GK., Brenner, LA., et al.[2022]

A new and simpler classification system for sinus of Valsalva aneurysms (SVAs) was developed, categorizing them into four types based on their rupture or protrusion locations, which could enhance surgical decision-making.

Surgical repair of SVAs showed excellent outcomes with no early postoperative deaths and good long-term recovery, indicating the safety and efficacy of the proposed surgical approaches for each SVA type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new and simple classification for sinus of Valsalva aneurysms and the corresponding surgical procedure. Guo, HW., Xiong, H., Xu, JP., et al.[2013]

A 23-year-old patient with a ruptured sinus of Valsalva aneurysm (SVA) presented with severe symptoms, including chest pain and shortness of breath, highlighting the importance of recognizing this rare but serious condition that can remain asymptomatic until rupture.

Echocardiography is crucial for diagnosing a ruptured SVA, and emergency surgical repair can lead to excellent outcomes, emphasizing the need for prompt intervention in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute rupture of a sinus of Valsalva aneurysm into the right atrium: a case report and a narrative review. Doost, A., Craig, JA., Soh, SY.[2020]

An 18-year-old female with a ruptured sinus of Valsalva aneurysm experienced cardiac tamponade, highlighting the critical need for immediate diagnosis and treatment of this rare condition.

The successful semi-urgent surgical resection of the aneurysm demonstrates that off-pump surgery can be a viable option in certain cases, providing a safe approach to managing this life-threatening anomaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac tamponade due to a ruptured aneurysm of the sinus of valsalva. Weijerse, A., van der Schoot, MJ., Maat, LP., et al.[2008]

A comprehensive analysis of adverse events in Veterans Health Administration mental health units revealed 87 root cause analysis reports and 9780 safety reports, highlighting a significant risk of various incidents, including 31 suicide attempts and 16 elopements.

Falls were the most frequently reported safety event, followed by medication errors and assaults, indicating that a broad approach to patient safety is essential in mental health settings, similar to medical units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. Mills, PD., Watts, BV., Shiner, B., et al.[2018]

The VA S.A.V.E. gatekeeper training program was successfully implemented in a remote trial with 214 participants, primarily spouses or partners of veterans, demonstrating feasibility in recruiting and retaining participants over six months.

While the study met most feasibility benchmarks, challenges such as generic advertising and the platform used for recruitment were identified, alongside effective strategies like targeting veterans' family members and emphasizing the urgency of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of recruitment and retention in a remote trial of gatekeeper training for close supports of military veterans: Mixed methods study. Teo, AR., Call, AA., Hooker, ER., et al.[2023]

In a pilot study involving 214 participants, the VA S.A.V.E. training significantly increased the use of gatekeeper behaviors for suicide prevention among veterans, with 66.7% to 84.9% of participants engaging in these behaviors compared to 44.4% to 77.1% in the control group.

Participants who completed the VA S.A.V.E. training reported high satisfaction and usability, indicating that the training is well-received and may lead to positive behavior changes in identifying and assisting veterans at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief video training for suicide prevention in veterans: A randomized controlled trial of VA S.A.V.E. Teo, AR., Hooker, ER., Call, AA., et al.[2023]

A 67-year-old female patient experienced a life-threatening cardiac tamponade due to a ruptured sinus of Valsalva aneurysm, leading to intrapericardial bleeding.

Despite undergoing surgical intervention, the patient unfortunately did not survive, highlighting the critical nature of timely treatment for such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruptured aneurysm of the left sinus of Valsalva into the pericardium. Doevendans, PA., Geskes, GG., van Aarnhem, G., et al.[2020]

Citations

1.

reporter.nih.gov

reporter.nih.gov/project-details/10861440

Randomized Controlled Effectiveness Trial of VA S.A.V.E. ...

Methodology: We will conduct a randomized controlled effectiveness trial of VA S.A.V.E. using a targeted social media and digital ad campaign to recruit close ...

2.

mentalhealth.va.gov

mentalhealth.va.gov/docs/data-sheets/2024/2024-Annual-Report-Part-1-of-2_508.pdf

2024 National Veteran Suicide Prevention Annual Report

This ninth annual report provides the most recent data regarding suicide among Veteran and non-Veteran U.S. adults, and about variation in suicide rates across ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12535588/

Evaluating the accuracy of the Veterans Health ...

REACH VET is a nationwide suicide prevention program based on a statistical model that is run monthly to produce estimates of every VA patient's ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1111/sltb.13028

Brief video training for suicide prevention in veterans: A ...

VA SAVE merits further investigation into its effectiveness as a brief, scalable gatekeeper training for suicide prevention in veterans.

5.

journal-veterans-studies.org

journal-veterans-studies.org/articles/10.21061/jvs.v10i1.525

Suicide Prevention Programs Currently Available to US ...

A scoping review was conducted to examine what types of suicide prevention programs are currently available for US veterans and their effectiveness.

6.

mirecc.va.gov

mirecc.va.gov/MIRECC/suicideprevention/Education/education_index.asp

Suicide Prevention - Education & Dissemination

VA S.A.V.E. Training. VA S.A.V.E. is a brief suicide prevention training that helps you act with care and compassion if you encounter a Veteran who is in crisis ...

7.

research.va.gov

research.va.gov/topics/suicide.cfm

Suicide Prevention

In 2019, VA's National Veteran Suicide Prevention Annual Report estimated that 6,139 U.S. Veterans died by suicide in 2017, an average of 16.8 per day. In that ...

8.

mentalhealth.va.gov

mentalhealth.va.gov/docs/data-sheets/2023/2023-National-Veteran-Suicide-Prevention-Annual-Report-FINAL-508.pdf

2023 National Veteran Suicide Prevention Annual Report

The report covers veteran suicide data from 2001-2021, including 2021, the first full year of COVID-19 data, and shows increases in 2021. Some age groups saw ...