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

Sponsor
White River Junction Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT06139887
Collaborator
VHA Office of Rural Health (Other)
25
1
2
24
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BESST
  • Other: Standard Mental Health Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
Primary Purpose:
Prevention
Official Title:
A Pilot RCT to Examine a Strategy to Engage Rural Veteran Patients After Community Care Treatment
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BESST

Patients randomized to the BESST intervention arm will receive the BESST intervention combined with standard mental health care.

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.
Other Names:
  • Standard Care
  • Other: Control

    Patients randomized to the control arm will receive standard mental health care alone.

    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.
    Other Names:
  • Standard Care
  • Outcome Measures

    Primary Outcome Measures

    1. Suicidal Ideation: Beck Scale for Suicidal Ideation (BSS) [Baseline to 3 months post-discharge]

      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.

    Secondary Outcome Measures

    1. Patient Engagement: Suicide-Related Coping Scale (SRCS) [Baseline to 3 months post-discharge]

      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.

    2. Patient Engagement: General Self-Efficacy Scale (GSES) [Baseline to 3 months post-discharge]

      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.

    3. Hopelessness: Beck Hopelessness Scale (BHS) [Baseline to 3 months post-discharge]

      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.

    4. Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) [Baseline to 3 months post-discharge]

      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.

    5. Suicide Attempts: Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline to 3 months post-discharge]

      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.

    6. Substance Use: Timeline Follow Back (TLFB) [Baseline to 3 months post-discharge]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 White River Junction VA Medical Center White River Junction Vermont United States 05009

    Sponsors and Collaborators

    • White River Junction Veterans Affairs Medical Center
    • VHA Office of Rural Health

    Investigators

    • Principal Investigator: Natalie Riblet, MD, MPH, White River Junction VA Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    White River Junction Veterans Affairs Medical Center
    ClinicalTrials.gov Identifier:
    NCT06139887
    Other Study ID Numbers:
    • 1701666
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by White River Junction Veterans Affairs Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2023