- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139887
Suicide Prevention Program for Veterans Discharged From Community Care Settings
Examining a Strategy to Engage Rural Veteran Patients After Community Care Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
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, 05009
- White River Junction VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 VA Medical Center (VAMC), the Togus VA Medical Center (VAMC), or the Manchester VA Medical Center (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
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: BESST
Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care.
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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.
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.
Other Names:
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Other: Control
Patients randomized to the control arm will receive standard mental health care alone.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)
Time Frame: 3 months post-baseline
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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.
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3 months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hopelessness: Beck Hopelessness Scale (BHS)
Time Frame: 3 months post-baseline
|
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.
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3 months post-baseline
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Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness
Time Frame: 3 months post-baseline
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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 6-42.
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3 months post-baseline
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Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness
Time Frame: 3 months post-baseline
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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 thwarted belongingness being 7-63.
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3 months post-baseline
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Patient Engagement: General Self-Efficacy Scale (GSES)
Time Frame: 3 months post-baseline
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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.
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3 months post-baseline
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Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale
Time Frame: 3 months post-baseline
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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.
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3 months post-baseline
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Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale
Time Frame: 3 months post-baseline
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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.
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3 months post-baseline
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Number of Participants With Substance Use at 3 Months Post-baseline
Time Frame: 3 months post-baseline
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The investigators will assess substance use at 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.
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3 months post-baseline
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Number of Participants With Suicide Attempts
Time Frame: 3 months post-baseline
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Suicide attempts is measured using the seven-item subscale on the Columbia-Suicide Severity Rating Scale (C-SSRS), a valid and reliable scale that asks patients to self-report on suicide attempts.
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3 months post-baseline
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Natalie Riblet, MD, MPH, White River Junction VA Medical Center
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1701666
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
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