2700 Participants Needed

Veteran Sponsorship for Suicide Prevention

DE
JC
Overseen ByJoseph C Geraci, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Background Young Veterans in the U.S. face a heightened risk of suicide, particularly during the first year after leaving military service-a period often referred to as the "deadly gap." Suicide rates among Veterans aged 18 to 34 have nearly doubled since 2001, and research shows that reintegration challenges during this transition are closely linked to increased suicide risk.

The Veteran Sponsorship Initiative (VSI) was developed to address this critical period by connecting Transitioning Servicemembers and Veterans (TSMVs) with trained, VA-certified peer sponsors. These sponsors help TSMVs navigate civilian life and access VA care. Early evaluations show that TSMVs matched with sponsors are more likely to report lower levels of reintegration difficulties, higher levels of social support, engage in VA services and report lower rates of depression and suicide risk.

This project enhances VSI by integrating predictive analytics-developed in partnership with Harvard Medical School and the DoW STARRS-LS team-to identify high-risk TSMVs before they leave the military. Those identified receive not only a sponsor but also targeted VA mental and health care services. This hybrid effectiveness-implementation study will evaluate the impact of this enhanced model (VSI+) on mental health outcomes and VA engagement among 2,700 high-risk TSMVs.

Method/Design

The purpose of this PEI proposal is to evaluate VSI expansion into VSI+ with enrollment occurring on four US Army installations (FY2026-2027). The study employs a pragmatic cluster-randomized trial with embedded mixed-method implementation evaluation to compare three arms:

1. Transition as Usual (TAU)

2. VSI Base= peer sponsorship and community support

3. VSI+= VSI Base plus VA stepped care services

The evaluation is guided by the RE-AIM framework to assess:

* Reach (enrollment rates)

* Effectiveness (reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes)

* Adoption (site and staff uptake)

* Implementation (fidelity and feasibility)

* Maintenance (sustainability)

Study Aims

1. Effectiveness: Evaluate the impact of VSI Base and VSI+ on reintegration difficulties, depression, anxiety, suicidal ideation/behavior, and VA utilization outcomes.

2. Implementation: Assess the feasibility and fidelity of implementing VSI Base and VSI+ across multiple sites using a bundled strategy.

3. Economic Impact: Estimate the budget impact of VSI Base and VSI+ on healthcare costs, including inpatient, emergency, and outpatient care.

Who Is on the Research Team?

DE

David E Goodrich, EdD MS MA

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

JC

Joseph C Geraci, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

EP

Erin P Finley, PhD MPH

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

ER

Emily R Edwards, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

RW

Richard W Seim

Principal Investigator

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

BB

Brigid B Connelly, MA

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

MS

Marianne S. Goodman, MD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

JY

Jean Yoon, PhD MHS

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for U.S. Transitioning Servicemembers and Veterans (TSMVs) aged 18 or older who are at high risk of suicide, especially during their first year after military service. Participants must enroll before discharge and plan to transition from one of the specified military installations during an active enrollment period.

Inclusion Criteria

I will join the study before leaving the military.
I plan to move from a specific military base during an open enrollment period.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (virtual)

Pre-Discharge Intervention

TSMVs receive approximately two sessions of VSI+ intervention prior to discharge, including suicide risk screening and initial case management

6 months
2 sessions (virtual)

Post-Discharge Intervention

TSMVs continue to receive VSI+ intervention, including ongoing case management and sponsor support, for approximately 6 months post-discharge

6 months
Monthly meetings (virtual or in-person)

Follow-up

Participants are monitored for reintegration difficulties, mental health outcomes, and VA utilization

12 months
3 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Onward Ops- receive peer sponsor and community support
  • VA stepped care services

Trial Overview

The study compares three approaches: usual transition support, peer sponsorship with community support (VSI Base), and VSI Base plus additional VA stepped care services (VSI+). It aims to see if these can reduce reintegration difficulties, depression, anxiety, suicidal thoughts/behaviors, and improve engagement with VA services.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Veteran Sponsorship Initiative+Experimental Treatment2 Interventions
Group II: Veteran Sponsorship Initiative BaseExperimental Treatment1 Intervention
Group III: Transition as UsualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

VISN 17 Center of Excellence for Research on Returning War Veterans

Collaborator

Department of War Study to Assess Risk & Resilience in Servicemembers - Longitudinal Study

Collaborator

James J. Peters Veterans Affairs Medical Center

Collaborator

Trials
59
Recruited
2,900+

Health Economics Resource Center

Collaborator

VISN 2 Mental Illness Research, Education and Clinical Center

Collaborator