- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446468
Suicide Prevention Study of VA-BIC in the Veteran Population (VA-BIC RCT)
Prevention of Suicide in Veterans Through Brief Intervention and Contact (VA-BIC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vermont
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White River Junction, Vermont, United States, 05001-3833
- White River Junction VA Medical Center, White River Junction, VT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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 Names:
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Experimental: 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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Scale for Suicide Ideation (BSS)
Time Frame: 1-month, 3-month, and 6- month post-discharge
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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.
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1-month, 3-month, and 6- month post-discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Suicide-Related Coping Scale (SRCS)
Time Frame: 1-month, 3-month, and 6- month post-discharge
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This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts.
Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations.
The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale.
Both subscales have shown good acceptable internal consistency.
The two factors are also sensitive to change over time.
The score range for the entire scale is 0-68.
Higher scores on the scale suggest better coping.
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1-month, 3-month, and 6- month post-discharge
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The Partners in Health Scale (PIH): Self-Management
Time Frame: 1-month, 3-months, and 6-months post discharge
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The Partners in Health Scale measures self-management of chronic health conditions.
It is a valid scale that includes 12 items.
Each question is measured on a Likert scale of 0-8.
Scores range from 0-96.
Higher scores reflect improved engagement and self-management of chronic health conditions.
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1-month, 3-months, and 6-months post discharge
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Beck Hopelessness Scale (BHS)
Time Frame: 1-month, 3-months and 6- months post-discharge
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The BHS is a 20-item self-report scale that assesses hopelessness over the past seven days.
Patients comment on feelings about the future, loss of motivation, and future expectations.
Total scores range from 0 to 20, with higher scores suggesting more hopelessness.
Higher scores on the BHS are associated with increased suicide risk.
The BHS has good reliability and validity and is sensitive to change.
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1-month, 3-months and 6- months post-discharge
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Interpersonal Needs Questionnaire-15 (INQ-15): Thwarted Belongingness
Time Frame: 1 month, 3-months, and 6-months post discharge
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The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness.
Each item is measured on a 7-point Likert scale.
Items 7, 8, 10, 13, 14, and 15 are reverse coded.
Scores on the total scale range from 15-105.
The thwarted belongingness subscale includes 9 items and scores range from 9-63 with higher scores indicating worse thwarted belongingness.
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1 month, 3-months, and 6-months post discharge
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Interpersonal Needs Questionnaire-15 (INQ-15): Perceived Burdensomeness
Time Frame: 1-month, 3-months, and 6-months post discharge
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The INQ-15 is a 15 item scale that measures thwarted belongingness and perceived burdensomeness.
Each item is measured on a 7-point Likert scale.
Items 7, 8, 10, 13, 14, and 15 are reverse coded.
Scores on the total scale range from 15-105.
The perceived burdensomeness subscale includes 6 items and scores range from 6-42 with higher scores indicating worse perceived burdensomeness.
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1-month, 3-months, and 6-months post discharge
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The Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: 1-month, 3-months and 6- months post-discharge
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The multidimensional scale of perceived social support is a valid scale that includes 12 items that measure several perceived sources of social support including family, friends, and significant others.
The score range is 1-7 with higher scores suggesting greater perceived support.
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1-month, 3-months and 6- months post-discharge
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App Engagement Scale (AES) for Mobile Applications
Time Frame: 6- month post-discharge
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The App Engagement Scale (AES) is adapted from the Mobile Application Rating Scale (uMARS) and is a valid scale.
All items are rated on a 5-point scale.
Scores range from 0-40 and higher scores indicate greater perceived quality of the mobile application.
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6- month post-discharge
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Continuity of Care
Time Frame: 3-months post discharge
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There is some evidence that improved continuity of care may lead to better mental health outcomes.
However, a single valid standardized measure of continuity of care for mental health has not been described in the literature.
Continuity of care was measured by assessing the total number of VA outpatient mental health visits attended within the three months after discharge.
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3-months post discharge
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Suicide Attempts: Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline to 6- months post-discharge
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The C-SSRS includes a 7-item subscale that assesses for actual and interrupted suicide attempts.
It is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
The C-SSRS subscale was used specifically to assess the number of participants who had an actual fatal or non-fatal suicide attempt within the first 6 months post discharge.
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Baseline to 6- months post-discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MINI International Neuropsychiatric Interview
Time Frame: Baseline
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The MINI will be used to collect mental health diagnostic information.
This scale has been validated against the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM).
It is a short, structured diagnostic interview that, on average, takes about 15 minutes to administer.
This will be administered at Baseline.
There is no score range for this measure.
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Baseline
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Natalie Riblet, MD MPH, White River Junction VA Medical Center, White River Junction, VT
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHBC-007-19F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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