Pilot RCT of Suicide Prevention Program for Veterans Discharged From Community Care Settings

Study Overview
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Brief Summary
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The goal of this pilot randomized controlled trial is to test our adapted suicide prevention program (the Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide or BESST) in rural Veterans discharged from community care mental health treatment settings. The main question it aims to answer is: Does BESST combined with standard care improve suicide-related outcomes among this population compared to standard care alone? Participants will be assigned by change to a treatment group. Some will receive the BESST intervention combined with standard care, and some will receive standard care alone. All participants will be in this research study for up to three months. Those receiving the BESST intervention will have: 1 one-hour brief educational session; Seven follow-up check-ins ( 30 minutes each) All participants will have three assessment interviews where researchers will ask about participants' mental health and treatment received outside of the VA. Researchers will compare participants assigned to the BESST intervention combined with standard care vs participants assigned to standard care alone to see if the BESST intervention improves suicide-related outcomes.

Official Title
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A Pilot RCT to Examine a Strategy to Engage Rural Veteran Patients After Community Care Treatment

Conditions
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Suicide Prevention

Intervention / Treatment
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* Behavioral: BESST
* Other: Standard Mental Health Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient was recently discharged from a VA community care mental health treatment setting The patient is at risk for self-harm Be a patient connected to the White River Junction VAMC, the Togus VAMC, or the Manchester VAMC; Be a Veteran; Be 18 years or older; Be able to speak English; Exclusion Criteria: Unable to provide informed consent; We do not plan to enroll any potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients; Study physician deems the patient not clinically appropriate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BESST<br>Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care. | Behavioral: BESST<br>* The BESST intervention is a suicide prevention program designed to meet the unique needs of Veterans receiving care from community mental health treatment settings. BESST can be delivered by a trained mental health staff member, such as a mental health nurse, social worker, psychologist, or psychiatrist. The intervention consists of two synergistic components that work to support the patient after a mental health-related discharge in community settings: 1) Brief educational session, 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 interventionist 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.<br>Other: Standard Mental Health Care<br>* Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings.<br>* Other names: Standard Care;|
| Other: Control<br>Patients randomized to the control arm will receive standard mental health care alone. | Other: Standard Mental Health Care<br>* Patients randomized to the control arm will receive standard mental health care alone. Standard mental health care simply refers to the regular care provided to patients around the time of discharge from community care settings.<br>* Other names: Standard Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation: Beck Scale for Suicidal 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. The BSS may be a measure of risk of suicide. There is evidence that the BSS is measurement invariant across time. | Baseline to 3 months post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Engagement: Suicide-Related Coping Scale (SRCS) | The SRCS 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. Higher scores on the scale suggest better coping. | Baseline to 3 months post-discharge | 
| Patient Engagement: General Self-Efficacy Scale (GSES) | This is a valid scale of self-efficacy that is designed for the general population (12 years or older) and it has been tested in various countries. | Baseline to 3 months post-discharge | 
| Hopelessness: Beck Hopelessness Scale (BHS) | The BHS is a 20-item self-report scale that assesses hopelessness over the past seven days. Patients report on feelings about the future, loss of motivation, and future expectations. Total scores range from 0 to 20, with higher scores suggesting more hopelessness. The BHS has good reliability and validity and is sensitive to change. There is some evidence that the BHS may be a measure of risk of suicide. | Baseline to 3 months post-discharge | 
| Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) | The INQ-15 is a 15-item self-report scale that measures thwarted belongingness and perceived burdensomeness. Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness. The INQ-15 may be a measure of risk of suicide. | Baseline to 3 months post-discharge | 
| Suicide Attempts: 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. The scale asks the assessor to document the actual and potential lethality of these behaviors. The C-SSRS is widely used in the VA. | Baseline to 3 months post-discharge | 
| Substance Use: Timeline Follow Back (TLFB) | We will assess substance use at baseline and follow-up assessments using a timeline follow-back approach. This method is commonly used in research studies to assess substance use patterns. | Baseline to 3 months post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health education, Clinical trial, Suicidal ideation, Suicide, attempted