NCT06139887

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 22, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

November 14, 2023

Results QC Date

July 16, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Mental health educationClinical trialSuicidal ideationSuicide, attempted

Outcome Measures

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.

    3 months post-baseline

Secondary Outcomes (8)

  • Hopelessness: Beck Hopelessness Scale (BHS)

    3 months post-baseline

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

    3 months post-baseline

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

    3 months post-baseline

  • Patient Engagement: General Self-Efficacy Scale (GSES)

    3 months post-baseline

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

    3 months post-baseline

  • +3 more secondary outcomes

Study Arms (2)

BESST

EXPERIMENTAL

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

Behavioral: BESSTOther: Standard Mental Health Care

Control

OTHER

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

Other: Standard Mental Health Care

Interventions

BESSTBEHAVIORAL

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.

BESST

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
BESSTControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

Location

MeSH Terms

Conditions

Suicide PreventionSuicidal IdeationSuicide, Attempted

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Natalie Riblet
Organization
White River Junction VA Medical Center

Study Officials

  • Natalie Riblet, MD, MPH

    White River Junction VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to treatment allocation and will remind the participant at each contact to not disclose their treatment status.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two groups in parallel: BESST plus standard care vs. standard care alone.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

October 1, 2023

Primary Completion

April 17, 2025

Study Completion

April 17, 2025

Last Updated

September 5, 2025

Results First Posted

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations