NCT06596044

Brief Summary

The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Sep 2028

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

September 3, 2024

Last Update Submit

April 21, 2026

Conditions

Keywords

Mental health educationClinical trialSuicidal ideationSuicide, attemptedSelf-injurious BehaviorSuicideSuicide Prevention

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)

    The Beck Scale for Suicidal Ideation (BSS) is a self-reported, 21-item scale that assesses symptoms of suicidal ideation. The total score 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 9 months post-baseline

Secondary Outcomes (4)

  • Mental Healthcare Utilization: The number of mental health visits attended

    Baseline to 3 months post-baseline

  • Patient perception of ability to cope with suicidal behavior: The Suicide-Related Coping Scale (SRCS)

    Baseline to 9 months post-baseline

  • Social Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15)

    Baseline to 9 months post-baseline

  • Suicide Attempt Events: Fatal and non-Fatal Suicide Attempts

    Baseline to 9 months post-baseline

Study Arms (2)

VA BIC

EXPERIMENTAL

Patients randomized to VA BIC will receive the VA BIC intervention plus standard care

Behavioral: VA BICOther: Standard Care

Standard Care

OTHER

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

Other: Standard Care

Interventions

VA BICBEHAVIORAL

VA BIC is a suicide prevention strategy that is designed to meet the needs of Veterans who receive acute psychiatric treatment. VA BIC can be delivered by a trained mental health provider (e.g., mental health nurse, social worker, psychologist, psychiatrist). VA BIC includes two synergistic elements to support the patient after a mental health discharge. The elements include a brief educational session, where the patient receives a one-on-one, one-hour, personalized educational session on suicide prevention. The session incorporates aspects of motivational interviewing. The patient then receives 7 regular follow-up contacts that are conducted by the interventionist. Here the interventionist monitors symptoms, assesses treatment adherence, reviews the safety plan, and assists the patient with engaging in steps to promote their well-being. The sessions incorporate aspects of motivational interviewing. Of note patients in this arm will also receive standard care.

VA BIC

Regardless of study assignment, all patients will have access to standard care provided upon mental health discharge in non-VA settings. VA staff will also follow standard procedures for mitigating risk including placing Veterans on high risk list when clinically appropriate.

Standard CareVA BIC

Eligibility Criteria

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

You may qualify if:

  • Veteran who is eligible to receive VA services;
  • years or older;
  • able to speak English;
  • received acute psychiatric treatment in a non-VA setting affiliated with VA in Northern New England;
  • endorse recent suicidal ideation (score 2+ on Beck Scale for Suicidal Ideation).

You may not qualify if:

  • Unable to provide informed consent;
  • Currently receiving assertive community treatment;
  • Potentially vulnerable populations including prisoners, institutionalized patients, or patients currently admitted on involuntary commitment status;
  • Study physician deems the patient is not clinically appropriate because of clinical status such as presence of active psychosis or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833, United States

RECRUITING

MeSH Terms

Conditions

Suicide PreventionSuicidal IdeationSuicide, AttemptedSelf-Injurious BehaviorSuicide

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Natalie Riblet, MD MPH

    White River Junction VA Medical Center, White River Junction, VT

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Riblet, MD MPH

CONTACT

Bradley V Watts, MD MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome 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: VA BIC plus standard care vs. standard care alone
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations