Recruiting

PREVAIL-VA

Sponsor:

VA Office of Research and Development

Code:

NCT07286383

Conditions

Suicide Risk

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PREVAIL

Study Details

Brief summary:

This study examines a novel way to prevent suicide among Veterans with serious mental illness (SMI). It will assess the efficacy of PREVAIL-VA, a 3-month intervention of 12, one-on-one sessions between a Peer Specialist (PS) and a Veteran that involve semi-structured conversations focused on hope, belongingness, support, and safety. PSs are Veterans with SMI trained to use their own experience and recovery to help other Veterans with SMI. PSs have improved mental health outcomes in other research, but this study would be the first to test their efficacy for suicide prevention in VHA. The project will compare outcomes of Veterans at risk for suicide receiving usual care, to PREVAIL-VA. This work is responsive to national calls for Veterans with SMI to receive support that is evidence-based, improves recovery (not just symptoms), and is tailored to individual needs. If successful, PREVAIL-VA could be adopted by the 1400 Peer Specialists employed in VA, greatly increasing the delivery of evidence-based services to Veterans at risk for suicide.

Conditions

Suicide Risk

Study ID

NCT07286383

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

There are two Inclusion criteria:

  • Moderate to high suicide risk according to one of the following occurring in the prior 3 months:

  • a completed Comprehensive Suicide Risk Evaluation (CSRE) indicating intermediate or high acute or chronic risk
  • a high-risk suicide PRF
  • a suicide attempt indicated on a Suicide Behavior or Overdose Report (SBOR)
  • a suicide safety plan completed in the past 6 months

AND

  • Current suicidal ideation according to the 9th item of the Patient health questionnaire (PHQ-9) > 0 at enrollment

  • While a positive 9th item usually precedes the CSRE, because the CSRE could have been administered in the 3 months prior to enrollment, the purpose of requiring a positive 9th item is to ensure more recent suicidal ideation.
  • It may be more difficult to show an intervention effect if the investigators enroll participants with no suicidal ideation at baseline.

Exclusion Criteria:

  • Inability to provide informed consent for any reason, including due to acute psychosis or mania, dementia, or active guardianship or durable power of attorney

  • These criteria will be determined according to medical record review and, if clarification needed, consultation with a treating provider.
  • The investigators will also screen for decision-making capacity using the Blessed Orientation, Memory, Concentration (BOMC) Test and a brief quiz about the study.
  • This quiz will involve an iterative process of querying the participants' understanding of consent information with a 10-item true/false test and providing feedback until an acceptable level of understanding is achieved (must get 100% correct after 3 tries to enroll).
  • Current or planned receipt of residential or intensive outpatient treatment
  • Plan to transfer or terminate care in the next 3 months
  • Homicidal ideation in the past 6 months or violent behavior in the past 12 months

Study Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: PREVAIL

12 session, peer specialist delivered, suicide prevention program

no intervention: Usual Care

Veterans assigned to this group will receive additional monitoring but no active intervention.

Interventions

PREVAIL

12 session, peer specialist delivered, suicide prevention program

Primary outcome measure

  • Computerized Adaptive Test- Suicide Scale; Columbia-Suicide Severity Rating Scale [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Matthew J Chinman, PhD

(412) 360-2438matthew.chinman@va.gov

Jessica R Dodge, PhD MSW MPH

(734) 845-3609Jessica.Dodge@va.gov

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Richard Goldberg, PhD

410-637-1851richard.goldberg@va.gov

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Matthew J Chinman, PhD

(412) 360-2438matthew.chinman@va.gov

Jessica R Dodge, PhD MSW MPH

(734) 845-3609Jessica.Dodge@va.gov

Principal Investigator:

Matthew J Chinman, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • suicide
  • peer support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-08.