Suicide Prevention Study of VA-BIC in the Veteran Population

NCT04446468 | Completed Results DMC

• 1 other identifier: MHBC-007-19F
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide Prevention

Keywords

Mental health education; Clinical Trial; Suicidal ideation; Suicide, attempted

Outcome Measures

Primary Outcomes (1)

• Beck Scale for Suicide Ideation (BSS)

  The BSS is a self-reported questionnaire that assesses severity of suicidal ideation. The BSS measures attitudes, behaviors, and plans to die by suicide. Each item on the BSS is scored on a scale from 0 to 2 and the first 19 of the 21 items are used to calculate a total score ranging from 0 - 38. The BSS has high reliability and is a valid measure of suicidal ideation. There is also evidence that the BSS is measurement invariant across time. The BSS is widely used in clinical trials, is sensitive to clinical change, and unlike most other measures of suicidal ideation, higher scores on the BSS are associated with death by suicide. While there is no established BSS cutoff score to classify suicide risk as high, low, or none, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation.

  1-month, 3-month, and 6- month post-discharge

Secondary Outcomes (9)

• Suicide-Related Coping Scale (SRCS)

  1-month, 3-month, and 6- month post-discharge

• The Partners in Health Scale (PIH): Self-Management

  1-month, 3-months, and 6-months post discharge

• Beck Hopelessness Scale (BHS)

  1-month, 3-months and 6- months post-discharge

• Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness

  1 month, 3-months, and 6-months post discharge

• Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness

  1-month, 3-months, and 6-months post discharge

Study Arms (2)

PEACE

EXPERIMENTAL

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.

Behavioral: PEACE; Other: Standard Psychiatric Hospital Discharge Care

Control

EXPERIMENTAL

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.

Other: Standard Psychiatric Hospital Discharge Care

Interventions

PEACE 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.

PEACE

Standard Psychiatric Hospital Discharge Care 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.

Also known as: Standard Care

Control; PEACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• White River Junction Veterans Affairs Medical Center: collaborator

Study Sites (1)

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

White River Junction, Vermont, 05001-3833, United States

Location

Related Publications (14)

• 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.

  PMID: 34360101 BACKGROUND

• 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.

  PMID: 34214935 BACKGROUND

• 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.

  PMID: 35199662 BACKGROUND

• 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.

  PMID: 35202942 BACKGROUND

• 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.

  PMID: 35382976 BACKGROUND

• 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.

  PMID: 35958652 BACKGROUND

• 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.

  PMID: 36383739 BACKGROUND

• 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.

  PMID: 36384820 BACKGROUND

• 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.

  PMID: 36931135 BACKGROUND

• 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.

  PMID: 36759108 BACKGROUND

• 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.

  PMID: 37019069 BACKGROUND

• 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.

  PMID: 37002596 BACKGROUND

• 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.

  PMID: 37167031 BACKGROUND

• 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.

  PMID: 37652208 BACKGROUND

MeSH Terms

Conditions

Suicide Prevention; Suicidal Ideation; Suicide, Attempted

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Natalie Riblet
• Organization: White River Junction VA Medical Center

natalie.riblet@va.gov

8022959363

Study Officials

• Natalie Riblet, MD MPH

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: March 19, 2021
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)