Suicide Prevention Study of VA-BIC in the Veteran Population

NCT ID: NCT04446468

Last Updated: 2026-01-28

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2025-09-25

Brief Summary

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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 following a psychiatric hospitalization. This may be due to problems with engagement in care and poor social connectedness. Although the VA has implemented tools to address Veteran suicide risk, suicide after psychiatric discharge remains an ongoing problem. This has highlighted the need to develop new interventions and approaches to post-discharge mental health care within the VA. In response, this project is a randomized control trial of an intervention an intervention called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE). This intervention is comprised of two synergistic and promising components to prevent suicide: 1) a mobile mental health app, which aims to improve social connectedness after discharge; and 2) a manual-based intervention called the Veterans Affairs Brief Intervention and Contact Program (VA-BIC), which promotes engagement in care. The overall goal of this study is to determine if the PEACE intervention combined with standard discharge care reduces suicidal ideation as compared to a control group receiving only standard discharge care.

Detailed Description

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Background: Suicide is a major public health concern in the U.S., and even more so in the Veteran population. Furthermore, the period following psychiatric hospitalization is one of the highest risk periods for suicide. Based on current evidence, some of the most important contributing factors to post-hospitalization suicide risk include problems with engagement in care, fragmented care, and lack of social connectedness. Other studies in civilian populations have also raised similar concerns, highlighting the need to identify novel and effective interventions or approaches to post-discharge mental health care.

Objectives: This project aims to 1) Identify the effect of PEACE on suicidal ideation after psychiatric hospitalization, compared to standard care alone; 2) Identify the effect of PEACE on social connectedness and engagement in care after psychiatric hospitalization, compared to standard care alone; and 3) Compare the effect of PEACE on suicide attempts and suicide deaths after psychiatric hospitalization, compared to standard care alone.

Methods: This is a single-site, assessor-blinded, randomized control trial of PEACE plus standard psychiatric hospital discharge care compared to standard psychiatric hospital discharge care alone. The trial will enroll up to 160 participants aged 18 years and older who are being discharged from the White River Junction VA Medical Center inpatient mental health unit. Participants will be randomized to either the PEACE intervention plus standard psychiatric discharge care or standard psychiatric discharge care alone. Suicidal ideation, hopelessness, social connectedness, engagement in care, suicide attempts, and app engagement (only those randomized to PEACE) will be measured at baseline and one, three, and six months post-discharge. Participants randomized to PEACE will also receive eight additional intervention contacts as part of the VA-BIC protocol.

Hypothesis: Veterans receiving the PEACE intervention will report greater improvements in suicidal thoughts and behaviors, hopelessness, social connectedness, and engagement in care at follow-up contact visits compared to Veterans receiving standard care alone.

Conditions

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Suicide Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two groups in parallel: PEACE plus standard psychiatric discharge care vs. standard psychiatric discharge care alone
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.

Study Groups

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PEACE

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 Type EXPERIMENTAL

PEACE

Intervention Type BEHAVIORAL

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.

Standard Psychiatric Hospital Discharge Care

Intervention Type OTHER

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.

Control

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.

Group Type EXPERIMENTAL

Standard Psychiatric Hospital Discharge Care

Intervention Type OTHER

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.

Interventions

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PEACE

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.

Intervention Type BEHAVIORAL

Standard Psychiatric Hospital Discharge Care

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.

Intervention Type OTHER

Other Intervention Names

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Standard Care

Eligibility Criteria

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Inclusion Criteria

* 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;
* Be a Veteran eligible to receive VA services;
* Be 18 years or older;
* Be able to speak English;
* Have access to a smart phone and express willingness to download a mobile app.

Exclusion Criteria

* Unable to provide informed consent;
* The investigators do not plan to enroll any potentially vulnerable populations including prisoners, or involuntarily committed patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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White River Junction Veterans Affairs Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Riblet, MD MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

White River Junction, Vermont, United States

Site Status

Countries

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United States

References

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Riblet NB, Soncrant C, Mills P, Yackel EE. Analysis of Reported Suicide Safety Events Among Veterans Who Received Treatment Through Department of Veterans Affairs-Contracted Community Care. Mil Med. 2023 Aug 29;188(9-10):e3173-e3181. doi: 10.1093/milmed/usad088.

Reference Type BACKGROUND
PMID: 37002596 (View on PubMed)

Cornelius SL, Berry T, Goodrich AJ, Shiner B, Riblet NB. The Effect of Meteorological, Pollution, and Geographic Exposures on Death by Suicide: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 23;18(15):7809. doi: 10.3390/ijerph18157809.

Reference Type BACKGROUND
PMID: 34360101 (View on PubMed)

Riblet NB, Gottlieb DJ, Watts BV, Levis M, Shiner B. Irregular hospital discharge from acute inpatient and residential mental health treatment settings in a large integrated healthcare system. Gen Hosp Psychiatry. 2021 Sep-Oct;72:7-14. doi: 10.1016/j.genhosppsych.2021.06.009. Epub 2021 Jun 26.

Reference Type BACKGROUND
PMID: 34214935 (View on PubMed)

Riblet NB, Gottlieb DJ, Watts BV, Levis M, Scott R, Shiner B. Is It Time for the Mental Health Field to Consider Unplanned Discharge a Key Metric of Patient Safety? J Nerv Ment Dis. 2022 Mar 1;210(3):227-230. doi: 10.1097/NMD.0000000000001425.

Reference Type BACKGROUND
PMID: 35199662 (View on PubMed)

Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18.

Reference Type BACKGROUND
PMID: 35202942 (View on PubMed)

Riblet NB, Varela M, Ashby W, Zubkoff L, Shiner B, Pogue J, Stevens SP, Wasserman D, Watts BV. Spreading a Strategy to Prevent Suicide After Psychiatric Hospitalization: Results of a Quality Improvement Spread Initiative. Jt Comm J Qual Patient Saf. 2022 Oct;48(10):503-512. doi: 10.1016/j.jcjq.2022.02.009. Epub 2022 Mar 6.

Reference Type BACKGROUND
PMID: 35382976 (View on PubMed)

Britton PC, Berrouiguet S, Riblet NB, Zhong BL. Editorial: Brief interventions in suicide prevention across the continuum of care. Front Psychiatry. 2022 Jul 26;13:976855. doi: 10.3389/fpsyt.2022.976855. eCollection 2022. No abstract available.

Reference Type BACKGROUND
PMID: 35958652 (View on PubMed)

Riblet NB, Matsunaga S, Lee Y, Young-Xu Y, Shiner B, Schnurr PP, Levis M, Watts BV. Tools to Detect Risk of Death by Suicide: A Systematic Review and Meta-Analysis. J Clin Psychiatry. 2022 Nov 16;84(1):21r14385. doi: 10.4088/JCP.21r14385.

Reference Type BACKGROUND
PMID: 36383739 (View on PubMed)

Riblet NB, Shiner B, Young-Xu Y, Watts BV. Lithium in the prevention of suicide in adults: systematic review and meta-analysis of clinical trials. BJPsych Open. 2022 Nov 17;8(6):e199. doi: 10.1192/bjo.2022.605.

Reference Type BACKGROUND
PMID: 36384820 (View on PubMed)

Riblet NB, Matsunaga S, Shiner B, Schnurr PP, Watts BV. Are suicide risk scales sensitive to change? A scoping review. J Psychiatr Res. 2023 May;161:170-178. doi: 10.1016/j.jpsychires.2023.03.007. Epub 2023 Mar 9.

Reference Type BACKGROUND
PMID: 36931135 (View on PubMed)

Riblet NBV, Watts BV. Another Reason to Quit Smoking: Results of a Prospective Study Examining Smoking, COPD, and Suicide. Chest. 2023 Feb;163(2):259-261. doi: 10.1016/j.chest.2022.10.016. No abstract available.

Reference Type BACKGROUND
PMID: 36759108 (View on PubMed)

Riblet NB, Young-Xu Y, Shiner B, Schnurr PP, Watts BV. The efficacy and safety of buprenorphine for the treatment of depression: A systematic review and meta-analysis. J Psychiatr Res. 2023 May;161:393-401. doi: 10.1016/j.jpsychires.2023.03.037. Epub 2023 Mar 30.

Reference Type BACKGROUND
PMID: 37019069 (View on PubMed)

Riblet NB, Gottlieb DJ, Shiner B, Zubkoff L, Rice K, Watts BV, Rusch B. An Analysis of Irregular Discharges From Residential Treatment Programs in the Department of Veterans Affairs Health Care System. Mil Med. 2023 Nov 3;188(11-12):e3657-e3666. doi: 10.1093/milmed/usad131.

Reference Type BACKGROUND
PMID: 37167031 (View on PubMed)

Kenneally L, Stevens S, Cornelius S, Shiner B, Rice K, Park J, Watts BV, Teja N, Riblet N. Pilot randomized controlled trial of a brief strategy to prevent suicide after discharge from residential addiction treatment. J Subst Use Addict Treat. 2023 Nov;154:209156. doi: 10.1016/j.josat.2023.209156. Epub 2023 Aug 29.

Reference Type BACKGROUND
PMID: 37652208 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MHBC-007-19F

Identifier Type: -

Identifier Source: org_study_id

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