PEACE App Intervention for Suicide Prevention in Veterans

(VA-BIC RCT Trial)

Overseen By Natalie Riblet, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prisoners, Involuntarily committed, others

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

Compensation: Varies

Number of Visits: 11

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks new ways to prevent suicide among Veterans recently discharged from psychiatric hospitals. It will test a new approach called PEACE (Prevention of suicide: Education, Awareness, Connection, and Engagement), which includes a mobile app to help Veterans feel more connected and a program to encourage adherence to mental health care plans. Veterans hospitalized for self-harm concerns who can use a smartphone might be suitable candidates. The study will compare this new method to the usual post-hospital care to determine its effectiveness in reducing suicidal thoughts. As an unphased trial, it offers Veterans the chance to contribute to innovative research that could enhance mental health care and support systems.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app and a manual-based intervention to support mental health care.

What prior data suggests that the PEACE intervention is safe for veterans?

Research has shown that the PEACE app is designed to be safe and helpful for veterans. The PEACE program combines a mobile app with regular check-ins with a mental health professional to enhance social connections and involvement in care.

Although specific safety data for the PEACE program is not available, its components, such as regular monitoring and educational support, are typically well-received. Programs like these generally aim to boost mental health without medications or invasive procedures, often resulting in fewer side effects.

Overall, the PEACE program is structured to be safe and supportive, focusing on improving mental health after hospital discharge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEACE intervention because it offers a comprehensive approach to suicide prevention that goes beyond standard post-discharge psychiatric care. Unlike traditional methods, which primarily focus on basic follow-up visits and safety planning, PEACE incorporates a personalized one-hour educational session, regular post-discharge contacts, and a mobile app designed to enhance social connectedness and provide ongoing educational support. This multifaceted approach aims to ensure continuous support and engagement for veterans, potentially reducing the risk of suicide after hospital discharge.

What evidence suggests that the PEACE intervention is effective for suicide prevention in veterans?

Research has shown that the PEACE program, available to participants in this trial, might help reduce suicidal thoughts in veterans. It employs a mobile app to enhance social connections and includes a program to keep veterans engaged in their care. Studies have found that such support can lower suicidal thoughts and actions. Mobile apps have also successfully treated mental health issues like depression and anxiety. Together, these components aim to assist veterans after hospital discharge, making the PEACE program a promising approach for preventing suicide. ^{1 6 7 8 9}

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 U.S. Veterans eligible for VA services who were hospitalized due to acute self-harm risk, can speak English, and are willing to use a smartphone app. It excludes those unable to consent or considered vulnerable such as prisoners or involuntarily committed patients.

Inclusion Criteria

I can use a smartphone and am willing to download an app.

Be a Veteran eligible to receive VA services;

Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm;

Exclusion Criteria

The investigators do not plan to enroll any potentially vulnerable populations including prisoners, or involuntarily committed patients.

Unable to provide informed consent;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PEACE intervention, which includes a mobile mental health app and the VA-BIC program, or standard discharge care

6 months

8 contacts (in-person or virtual) for PEACE group

Follow-up

Participants are monitored for suicidal ideation, social connectedness, and engagement in care at one, three, and six months post-discharge

6 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PEACE

Trial Overview The study tests the PEACE intervention, which includes a mental health app and the VA-BIC program aimed at improving social connections and care engagement post-discharge, against standard psychiatric discharge care in preventing suicide.

How Is the Trial Designed?

Group I: PEACE Experimental Treatment 2 Interventions

The PEACE intervention will be delivered by a trained mental health staff member, such as a study psychologist, mental health nurse, social worker, or psychiatrist. The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide. Patients in this arm will also continue to receive standard post-discharge psychiatric care.

Group II: Control Experimental Treatment 1 Intervention

Those randomized to the control arm will receive standard psychiatric hospital discharge care alone. Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy.

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

In a study of 1962 male veterans aged 60 and older, 6% reported suicidal ideation in the past two weeks, with combat veterans showing higher rates (9.2%) compared to non-combat veterans (4.0%).

Major depression and physical health issues were the strongest risk factors for suicidal ideation in combat veterans, while generalized anxiety disorder was the key risk factor for non-combat veterans, highlighting the need for targeted interventions to address these mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidality among older male veterans in the United States: results from the National Health and Resilience in Veterans Study. Fanning, JR., Pietrzak, RH.[2013]

In a study of 129 participants, the app-assisted treatment (TAU+APP) showed a smaller decrease in self-reported suicide risk compared to standard treatment alone (TAU), indicating a medium effect size, which raises concerns about the integration of technology in therapy.

No significant differences were found in depressive symptoms between the two groups, suggesting that while the app may not enhance depression treatment, it could complicate suicide risk management, highlighting the need for careful consideration of how technology is used in psychological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an App-Assisted Treatment for Suicide Prevention in a Randomized Controlled Trial: Effects on Suicide Risk and Depression. O'Toole, MS., Arendt, MB., Pedersen, CM.[2022]

The study evaluated the feasibility of two mental health apps, BackUp and mEMA, for treating depressed outpatients with suicidal ideation, involving 17 participants over a 3-month period.

Both apps were found to be usable and acceptable, scoring above the thresholds for usability and satisfaction, but the study did not meet the criteria for sufficient uptake, indicating that further exploration is needed for integrating these apps into routine mental healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients. Nuij, C., van Ballegooijen, W., de Beurs, D., et al.[2023]

In a study of 3,356 older US military veterans, 6.6% reported suicidal ideation in the past year, highlighting a significant prevalence of suicidal thoughts in this population.

Factors such as loneliness and lack of purpose in life were strongly linked to suicidal thoughts, suggesting that addressing these issues could be important for preventing suicide among older veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidal Thoughts and Behaviors in Older U.S. Military Veterans: Results From the National Health and Resilience in Veterans Study. Fischer, IC., Nichter, B., Aunon, FM., et al.[2023]

U.S. veterans are significantly more likely to experience suicidal ideation and planning compared to nonveterans, with adjusted odds ratios of 1.33 and 1.52 respectively, based on a large study of 479,801 adults from 2008 to 2019.

While veterans showed higher rates of suicidal thoughts and planning, the difference in past-year suicide attempts was not statistically significant, indicating a complex relationship that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national examination of suicidal ideation, planning, and attempts among United States adults: Differences by military veteran status, 2008-2019. Hoopsick, RA., Yockey, RA.[2023]

Out of 69 assessed depression and suicide prevention apps, only 5 (7%) included all six recommended suicide prevention strategies, highlighting a significant gap in adherence to evidence-based guidelines.

Several popular apps provided incorrect crisis helpline numbers, raising concerns about the safety and reliability of mental health resources available to users, particularly given that some apps had over a million downloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention and depression apps' suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines. Martinengo, L., Van Galen, L., Lum, E., et al.[2022]

A study of 45,741 Iraq and Afghanistan war veterans revealed that factors like longer time from deployment to seeking VA care and alcohol use disorder significantly increased the risk of suicidal thoughts and plans.

Hispanic veterans showed a lower risk of suicidality compared to white veterans, suggesting that targeting modifiable risk factors, such as timely access to care and addressing alcohol use, could be effective in suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide risk in Iraq and Afghanistan veterans with mental health problems in VA care. Maguen, S., Madden, E., Cohen, BE., et al.[2015]

A significant majority (81%) of OEF/OIF veterans with positive depression screens received brief structured assessments (BSAs) for suicidal ideation within one month, with 94% of these assessments conducted within one day, indicating a timely response to potential risks.

There were notable differences in assessment completion rates based on demographics and clinical settings, with men being more likely to be assessed than women, and assessments being less likely to occur in later months of the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief assessment for suicidal ideation in OEF/OIF veterans with positive depression screens. Dobscha, SK., Corson, K., Helmer, DA., et al.[2022]

The REACH VET program, developed by the U.S. Veterans Health Administration, successfully identified and connected 98% of 6,579 veterans at risk of suicide with appropriate care by October 2020, demonstrating its efficacy in suicide prevention.

The implementation of this program in the largest U.S. healthcare system shows that using a statistical model for suicide prediction can be effectively integrated into clinical practice to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Veterans Health Administration REACH VET Program: Suicide Predictive Modeling in Practice. Matarazzo, BB., Eagan, A., Landes, SJ., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/10975924

Prevention of Suicide in Veterans Through Brief ... In response, we developed a promising suicide prevention strategy called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE), which ...

2. clinicaltrial.be clinicaltrial.be/en/details/54824?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Suicide Prevention Study of VA-BIC in the Veteran Populat... Participants will be randomized to either the PEACE intervention plus standard psychiatric discharge care or standard psychiatric discharge care ...

3. clinconnect.io clinconnect.io/trials/NCT04446468

Suicide Prevention Study of VA-BIC in the Veteran - ClinConnect To address this, the study is testing a new program called PEACE, which includes a mobile app designed to help Veterans stay connected with others and a program ...

4. research.va.gov research.va.gov/topics/suicide.cfm

Suicide Prevention Psychosocial interventions are effective in reducing suicide ideation, plan, attempt, and death among individuals with psychotic symptoms.

5. mdpi.com mdpi.com/2077-0383/11/19/5616

The Effectiveness of Mobile Apps for Monitoring and ... App-delivered interventions have been shown to be useful in the treatment of several psychiatric disorders, such as depression, anxiety, substance abuse ...

6. research.va.gov research.va.gov/about/funded_research/proj-details-FY2024.cfm?pid=677909

IK2CX001920-01A2 - Prevention of Suicide in Veterans ... Title: Prevention of Suicide in Veterans Through Brief Intervention and Contact (VA-BIC) ; Principal Investigator: Natalie Riblet ; Location: White River Junction ...

7. hsrd.research.va.gov hsrd.research.va.gov/research_topics/suicide-prevention.cfm

Suicide Prevention - VA Health Systems Research This study evaluated whether virtual mental health service use affects the risk of individual-level suicide-related events (SREs). Findings ...

8. texassuicideprevention.org texassuicideprevention.org/wp-content/uploads/2022/03/Community-Based-Intervention-for-Suicide-Prevention.pdf

Community Engagement and Partnerships Program Toolkit guides communities through the process of building coalitions to raise awareness about safe storage and its connection to suicide prevention. • Safe ...

9. data.va.gov data.va.gov/dataset/Suicide-Prevention-Applications-Network-SPAN-/xirr-5jyd

Suicide Prevention Applications Network (SPAN) ... ResourcesContact Information. VA Data Strategy. VA Data Strategy · Questions about our Strategy? Contact Us. Open Data Resources. Open Data - Managing ...