Suicide Prevention Program for Veterans

Overseen By Natalie Riblet, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, Dementia, others

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

Compensation: Varies

Number of Visits: 6

Duration: 9 months

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment VA BIC in the Suicide Prevention Program for Veterans?

The World Health Organization's Brief Intervention and Contact (BIC) program has shown effectiveness in preventing suicide, and a version adapted for the U.S. Department of Veterans Affairs (VA) was studied to determine its preliminary effects, suggesting potential benefits for veterans. ^{1 2 3 4 5}

Is the Suicide Prevention Program for Veterans generally safe for humans?

The SAFE VET program, which combines Safety Planning Intervention with structured follow-up, includes safety considerations for veterans at risk for suicide. However, there is a lack of consistent reporting on adverse events in suicide prevention trials, making it difficult to fully evaluate the safety of such interventions. ^{3 6 7 8 9}

How does the VA BIC treatment for suicide prevention in veterans differ from other treatments?

The VA BIC treatment is unique because it adapts the World Health Organization's Brief Intervention and Contact program specifically for veterans, focusing on preventing suicide after psychiatric discharge through brief interventions and ongoing contact, which is not a standard approach in other treatments. ^{1 3 10 11 12}

What is the purpose of this trial?

The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.

Research Team

Natalie Riblet, MD MPH

Principal Investigator

White River Junction VA Medical Center, White River Junction, VT

Eligibility Criteria

This trial is for Veterans at high risk of suicide who have recently received acute mental health treatment in non-VA settings. Details on specific inclusion and exclusion criteria are not provided, but it's likely that participants must be Veterans with recent mental health crises.

Inclusion Criteria

Endorse recent suicidal ideation (score 2+ on Beck Scale for Suicidal Ideation)

Received acute psychiatric treatment in a non-VA setting affiliated with VA in Northern New England

Veteran who is eligible to receive VA services

Exclusion Criteria

Study physician deems the patient is not clinically appropriate because of clinical status such as presence of active psychosis or dementia.

I am currently in an assertive community treatment program.

Potentially vulnerable populations including prisoners, institutionalized patients, or patients currently admitted on involuntary commitment status

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VA BIC intervention plus standard care or standard care alone

9 months

Baseline, 3, 6, and 9 months follow-up assessments

Follow-up

Participants are monitored for suicidal ideation, mental health care engagement, social connectedness, and suicidal behavior

9 months

3, 6, and 9 months follow-up assessments

Treatment Details

Interventions

• VA BIC

Trial Overview The study compares the effectiveness of a standard care approach versus the VA Brief Intervention and Contact Program (VA BIC) in preventing suicide among high-risk Veterans after discharge from community care.

Participant Groups

Group I: VA BIC Experimental Treatment 2 Interventions

Patients randomized to VA BIC will receive the VA BIC intervention plus standard care

Group II: Standard Care Experimental Treatment 1 Intervention

Patients randomized to the control arm will receive standard care alone.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

White River Junction Veterans Affairs Medical Center

Collaborator

Trials

32

Recruited

17,900+

Findings from Research

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 qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

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]

75% of reported suicides in psychiatric settings since 1995 highlight the critical need for enhanced patient safety measures in these environments.

The Veterans Health Administration has successfully implemented a culture of suicide-specific safety in their inpatient psychiatric units, demonstrating effective operational strategies, although there are still limitations and gaps in current practices and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide-specific Safety in the Inpatient Psychiatric Unit. De Santis, ML., Myrick, H., Lamis, DA., et al.[2022]

A review of 51 root cause analysis reports on veteran suicides revealed that common vulnerabilities included inadequate assessment of suicidal risk, poor coordination of care, and delays in accessing services.

Recommended prevention strategies focused on enhancing referral processes, improving staff education on suicide assessment, and ensuring follow-up care for veterans, which could significantly reduce suicide rates among veterans of Operations Iraqi Freedom and Enduring Freedom.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic vulnerabilities to suicide among veterans from the Iraq and Afghanistan Conflicts: review of case reports from a National Veterans Affairs Database. Mills, PD., Huber, SJ., Vince Watts, B., et al.[2022]

A study involving 602 community-based counseling center staff from the U.S. Department of Veterans Affairs demonstrated that a brief standardized gatekeeper training program significantly improved knowledge and self-efficacy in identifying and referring veterans at risk for suicide (p < .0001).

Nonclinical staff showed greater improvements in knowledge (effect size 0.96) and self-efficacy (effect size 0.89) compared to clinical staff, indicating that gatekeeper training is particularly effective for enhancing the skills of nonclinical personnel in suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of gatekeeper training for suicide prevention in veterans. Matthieu, MM., Cross, W., Batres, AR., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Trial of a Brief Intervention to Prevent Suicide After Inpatient Psychiatric Discharge. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment Suicide Risk Modeling Clinical Program in the Veterans Health Administration. [2022]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Suicide Risk Assessment and Prevention: A Systematic Review Focusing on Veterans. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Local implementation evaluation of a suicide prevention predictive model at a large VA health care system. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Suicide-specific Safety in the Inpatient Psychiatric Unit. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Systemic vulnerabilities to suicide among veterans from the Iraq and Afghanistan Conflicts: review of case reports from a National Veterans Affairs Database. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of gatekeeper training for suicide prevention in veterans. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Postdischarge Behavioral Health Treatment and 6-Month Reattempt Rate for Veterans Hospitalized for Suicide Attempt. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Increasing chaplain support for veterans at high risk for suicide through targeted outreach: A quality improvement initiative. [2022]