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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the VA Brief Intervention and Contact Program (VA BIC) can reduce suicide risk among Veterans. It targets Veterans who have recently received mental health treatment in non-VA settings and face a high risk of suicide after discharge. Participants will receive either standard care or the VA BIC intervention in addition to standard care. Veterans who speak English, have recently experienced suicidal thoughts, and have been treated in a non-VA psychiatric setting in Northern New England may qualify for this trial. As an unphased trial, it offers Veterans the chance to contribute to significant research that could improve suicide prevention strategies.

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 prior data suggests that the VA BIC intervention is safe for Veterans?

Research has shown that the VA Brief Intervention and Contact Program (VA BIC) is being studied to help lower the risk of suicide among Veterans. An initial study found that participants handled the VA BIC easily, and no major adverse side effects were reported. The program focuses on providing support and follow-up contact after Veterans leave a mental health care facility. This approach has shown promise in helping Veterans feel more connected and reducing their risk of suicide.

While detailed safety information remains limited, the program's emphasis on communication and support suggests it is a low-risk option. It is important to note that the VA is dedicated to ensuring the safety of its programs, especially for those at high risk. Overall, the VA BIC appears to be a safe choice for Veterans seeking to reduce their suicide risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VA BIC program because it combines standard care with a specialized intervention aimed at enhancing suicide prevention for veterans. Unlike traditional approaches that focus solely on counseling or medication, VA BIC integrates these with behavioral interventions tailored specifically for veterans, providing a more holistic support system. This program has the potential to address unique challenges faced by veterans, offering a comprehensive approach that could improve outcomes and reduce suicide rates more effectively than existing methods.

What evidence suggests that the VA BIC program is effective for suicide prevention in Veterans?

Research has shown that the VA Brief Intervention and Contact Program (VA BIC), which participants in this trial may receive, might help lower the risk of suicide in Veterans. A small study found that this program improved key factors related to suicide risk, such as feelings of isolation, especially after hospital discharge. These early findings suggest that the VA BIC could be a helpful approach for Veterans at high risk of suicide. While more research is needed, the initial results are encouraging for this program. ^{1 2 3 4 5}

Who Is on the Research Team?

Natalie Riblet, MD MPH

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

Citations

1. mentalhealth.va.gov mentalhealth.va.gov/suicide_prevention/data.asp

Veteran Suicide Data and Reporting The VA conducts the largest national analysis of Veteran suicide rates each year. Findings are made available to the public in an Annual Report.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04446468

Suicide Prevention Study of VA-BIC in the Veteran ... The VA is committed to reducing suicide in the U.S. Veteran population. Over 6,000 Veterans die from suicide each year, and this risk is particularly high ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562975/

Pilot Randomized Controlled Trial of a Brief Strategy to ... We conducted a pilot, randomized controlled trial of a brief suicide prevention strategy called Veterans Affairs Brief Intervention and Contact Program (VA BIC)

4. 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 This Department of Veterans Affairs (VA) “2023 National Veteran Suicide Prevention Annual Report” provides new information regarding suicide mortality among ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.202000537

A Pilot Randomized Trial of a Brief Intervention to Prevent ... The VA BIC may improve measures of suicide risk, such as thwarted belongingness, in the period after a hospital discharge. •. Future research ...