Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios

In the United States (U.S.), suicide is a major public health concern. U.S. Veterans who live in rural areas may be at even higher risk for suicide than their urban counterparts. Available evidence indicates that suicide risk in rural U.S. Veterans is most concentrated during high-risk care transition scenarios such as discharge from an emergency room. There is limited knowledge about effective interventions to address suicide risk. There is a critical need to develop targeted interventions that address suicide risk during high-risk care transition periods. To be effective, these interventions should address key contributors to suicide risk such as reduced engagement in treatment. This clinical trial evaluates the effect of a suicide prevention intervention to support treatment engagement during high risk transition periods such as discharge from an emergency room.

Study Overview

• Status: Completed
• Conditions: Suicidal and Self-injurious Behavior
• Intervention / Treatment: Behavioral: Suicide Prevention Program

Detailed Description

In the United States (U.S.), death by suicide is a notable public health concern and a particular problem in the U.S. Veteran population. Furthermore, U.S. Veterans who live in rural areas may be at even greater risk for suicide than their urban counterparts. These risks may be concentrated during times of transition in their treatment such as after emergency room discharge. Multiple interventions have been developed to target suicide risk during periods of transition but there is limited evidence regarding their efficacy in preventing suicide. Furthermore, a key contributor to suicide risk may include limited or no engagement in care. Therefore, developing interventions to support engagement in treatment may be effective ways to help mitigate suicide risk and promote participation in care. This clinical trial studies an intervention that is designed to help support treatment engagement during periods of high risk in Veterans who live in rural areas. The trial will recruit Veterans from various treatment settings such as the emergency room, residential drug treatment programs, primary care mental health clinics, and/or inpatient psychiatric units and follow them for a period of six months. The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • White River Junction VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inpatient psychiatric unit:

• 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 able to speak English

Inpatient medical-surgical unit:

• Received a mental health consultation during admission on the medical-surgical unit
• Per the consult-liaison psychiatrist, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
• Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English

Residential Rehabilitation Center (RRC) program:

• Per the RRC treatment team, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
• Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English

Primary Mental Health Clinic (PMHC):

• The patient was recently seen for a new evaluation in the WRJ PMHC clinic or a local integrated care clinic that are part of the White River Junction VA Medical Center Catchment Area (i.e., Burlington, Littleton, Rutland, Bennington, Brattleboro, or Keene) by either the mental health nurse practitioner, the psychologist, the psychiatry resident or a psychiatric attending
• The patient is currently at risk for self-harm including suicidal ideation of any severity, suicide attempt, or self-harm; This could have been identified based on a formal suicide assessment scale such as the Columbia Suicide Severity Rating Scale or by clinician assessment as documented in the intake note
• Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English

Exclusion Criteria:

• Unable to provide informed consent
• Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suicide Prevention Program; Behavioral: Suicide Prevention Program Structured care management to improve adherence to discharge planning.	Behavioral: Suicide Prevention Program; Structured care management to improve adherence to discharge planning.
No Intervention: Usual Care; Standard care that occurs as part of mental health treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Beck Scale for Suicidal Ideation (BSS)	The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated.	Change from Baseline BSS at 1-, 3-, and 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Beck Scale for Hopelessness (BHS)	The BHS ranges from 0-20 with higher scores associated with increased hopelessness.	Change from Baseline BHS at 1-, 3-, and 6-months
Columbia Suicide Severity Rating Scale (C-SSRS)	The C-SSRS 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.	Number of events according to the CSSR-S at 1-, 3-, and 6-months
The Partners in Health Scale (PIH) (Self Management)	The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Scores range from 0-72. Higher scores indicate better self-management. Mean scores at baseline were calculated.	Change from Baseline PIH at 1-, 3-, and 6-months
The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)	The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for thwarted belongingness being 7-49. Mean scores at baseline were calculated.	Baseline, 1-month, 3-month, 6-month
Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)	The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The score range for the entire scale is 15-105, with the score range for perceived burdensomeness being 7-49. The perceived burdensomeness Mean scores at baseline were calculated.	Change from Baseline INQ-15 PB at 1-, 3-, and 6-months
Multidimensional Scale of Perceived Social Support (MSPSS)	The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant others. The scale has been shown to have good internal and test-retest reliability as well as good validity. The score range is 1-7 with higher values indicating increased perception of social support.	Change from Baseline MSPSS at 1-, 3-, and 6-months
Suicide-Related Coping Scale (SRCS)	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. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. The score range for the entire scale is 0-68 with the External Coping being 0-28 and the Internal Coping being 0-28. Higher scores indicate increased perception of suicide-related coping. Mean scores at baseline were calculated.	Change from Baseline SRCS at 1-, 3-, and 6-months
App Engagement Scale (AES) - for Mobile Applications	The App Engagement Scale (AES) is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent" with scores ranging from 0 - 40. Higher scores are associated with increased perceived quality of the mobile application.	Change in AES scores at 1- and 6-months

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: Brian R Shiner, MD, MPH, White River Junction Veterans Affairs Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Suicidal and Self-injurious Behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Self-Injurious Behavior; Suicide Prevention
• Other Study ID Numbers: 1439938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No