CClinicalTrials.gg
CompletedNCT06139887Updated Sep 5, 2025Results posted

Suicide Prevention Program for Veterans Discharged From Community Care Settings

An interventional study of BESST and Standard Mental Health Care in Suicide Prevention, sponsored by White River Junction Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by White River Junction Veterans Affairs Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Suicide Prevention

Keywords

  • Mental health education
  • Clinical trial
  • Suicidal ideation
  • Suicide, attempted
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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 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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    BESST

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

    Behavioral: BESST · Other: Standard Mental Health Care

  • Other
    Control

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

    Other: Standard Mental Health Care

Interventions

  • BehavioralBESST

    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.

  • OtherStandard 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.

    Also known as: Standard Care

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months post-baseline

Secondary outcomes

  1. 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.

    Time frame: 3 months post-baseline

  2. Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness

    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.

    Time frame: 3 months post-baseline

  3. Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness

    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.

    Time frame: 3 months post-baseline

  4. 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.

    Time frame: 3 months post-baseline

  5. Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale

    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.

    Time frame: 3 months post-baseline

  6. Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale

    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.

    Time frame: 3 months post-baseline

  7. Number of Participants With Suicide Attempts

    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.

    Time frame: 3 months post-baseline

  8. Number of Participants With Substance Use at 3 Months Post-baseline

    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.

    Time frame: 3 months post-baseline

06

Results

Posted Aug 22, 2025

Participant flow

Participant flow — Overall Study
MilestoneBESSTControl
Started1010
Completed1010
Not completed00

Outcome measures

PrimarySuicidal 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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)
units on a scaleBESSTControl
Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)2.0 ± 4.2210.7 ± 9.48
SecondaryHopelessness: 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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Hopelessness: Beck Hopelessness Scale (BHS)
units on a scaleBESSTControl
Hopelessness: Beck Hopelessness Scale (BHS)5.6 ± 4.7410.4 ± 6.50
SecondaryConnectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness

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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness
units on a scaleBESSTControl
Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Perceived Burdensomeness10.2 ± 5.9817.4 ± 12.24
SecondaryConnectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness

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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness
units on a scaleBESSTControl
Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15) Thwarted Belongingness29.1 ± 11.332.3 ± 15.72
SecondaryPatient 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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Patient Engagement: General Self-Efficacy Scale (GSES)
units on a scaleBESSTControl
Patient Engagement: General Self-Efficacy Scale (GSES)30.4 ± 7.8528.1 ± 6.59
SecondaryPatient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale

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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale
units on a scaleBESSTControl
Patient Engagement: Suicide-Related Coping Scale (SRCS) External Coping Subscale24.6 ± 3.6322.1 ± 7.26
SecondaryPatient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale

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.

Time frame:
3 months post-baseline
Reported as:
Mean · units on a scale
Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale
units on a scaleBESSTControl
Patient Engagement: Suicide Related Coping Scale (SRCS) Internal Coping Subscale25.2 ± 4.3920.2 ± 7.79
SecondaryNumber of Participants With Suicide Attempts

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.

Time frame:
3 months post-baseline
Reported as:
Count of participants · Participants
Number of Participants With Suicide Attempts
ParticipantsBESSTControl
Number of Participants With Suicide Attempts00
SecondaryNumber of Participants With Substance Use at 3 Months Post-baseline

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.

Time frame:
3 months post-baseline
Reported as:
Count of participants · Participants
Number of Participants With Substance Use at 3 Months Post-baseline
ParticipantsBESSTControl
Number of Participants With Substance Use at 3 Months Post-baseline35

Adverse events

Collected over Adverse event data were collected throughout the entirety of the study participant activities (approximately 3 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BESST0/10 (0%)0/10 (0%)4/10 (40%)
Control0/10 (0%)0/10 (0%)4/10 (40%)
Most frequent other events
Most frequent other events
EventBESSTControl
Suicidal behaviorPsychiatric disorders2/104/10
Psychological distressPsychiatric disorders2/100/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)BESSTControlTotal
Mean42.7 ± 9.0842.0 ± 11.6342.35 ± 10.16
Sex: Female, Male
Sex: Female, Male(Participants)BESSTControlTotal
Female112
Male9918
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BESSTControlTotal
Hispanic or Latino101
Not Hispanic or Latino91019
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BESSTControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White101020
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)BESSTControlTotal
United States101020
The Beck Scale for Suicidal Ideation (BSS)
The Beck Scale for Suicidal Ideation (BSS)(units on a scale)BESSTControlTotal
Mean4.6 ± 6.2939.4 ± 9.87.0 ± 8.39
The Beck Scale for Hopelessness (BHS)
The Beck Scale for Hopelessness (BHS)(units on a scale)BESSTControlTotal
Mean9.8 ± 4.498.7 ± 3.439.25 ± 3.93
Interpersonal Needs Questionnaire-15, Perceived Burdensomeness (INQ-15 PB)
Interpersonal Needs Questionnaire-15, Perceived Burdensomeness (INQ-15 PB)(units on a scale)BESSTControlTotal
Mean16.2 ± 8.6515.3 ± 6.8215.75 ± 7.59

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • White River Junction VA Medical Center
    White River Junction, Vermont 05009, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 27, 2023
  • Informed consent form · Jan 2, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT06139887
Lead sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
VHA Office of Rural Health
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Oct 1, 2023
Primary completion
Apr 17, 2025
Completion
Apr 17, 2025
Results posted
Aug 22, 2025
Last update
Sep 5, 2025

Study contacts

Natalie Riblet, MD, MPH
principal investigator · White River Junction VA Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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