Suicide Prevention Program for Veterans Discharged From Community Care Settings

Suicide Prevention Clinical Trial

Official title:

Examining a Strategy to Engage Rural Veteran Patients After Community Care Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139887
• Other study ID #: 1701666
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: White River Junction Veterans Affairs Medical Center
• Contact: Natalie Riblet, MD, MPH
• Phone: 8022959363
• Email: natalie.riblet[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot randomized controlled trial is to test an 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 they will be asked about their mental health and treatment received outside of the VA. The investigators 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;
• The investigators 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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Behavioral:
• BESST
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.

Other:
• Standard Mental Health Care
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.

Locations

Country	Name	City	State
United States	White River Junction VA Medical Center	White River Junction	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center	VHA Office of Rural Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)	The Beck Scale for Suicidal Ideation (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.	Baseline to 3 months post-discharge
Secondary	Patient Engagement: Suicide-Related Coping Scale (SRCS)	The Suicide-Related Coping Scale (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. 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.	Baseline to 3 months post-discharge
Secondary	Patient Engagement: General Self-Efficacy Scale (GSES)	The General Self-Efficacy Scale (GSES) 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. It is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. Total scores range from 10 to 40, with higher scores suggesting increased self-efficacy.	Baseline to 3 months post-discharge
Secondary	Hopelessness: Beck Hopelessness Scale (BHS)	The Beck Hopelessness Scale (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
Secondary	Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15)	The Interpersonal Needs Questionnaire-15 (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.	Baseline to 3 months post-discharge
Secondary	Suicide Attempts: Columbia-Suicide Severity Rating Scale (C-SSRS)	The Columbia-Suicide Severity Rating Scale (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. There are two subscales within the C-SSRS: suicidal ideation (range: 0-5, with higher scores suggesting increased suicidal ideation) and intensity of ideation (range: 0-25, with higher scores suggesting increased intensity).	Baseline to 3 months post-discharge
Secondary	Substance Use: Timeline Follow Back (TLFB)	The investigators 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. Numerical scores do not apply to this assessment.	Baseline to 3 months post-discharge