Testing the Use of VA Peer Specialists to Prevent Veteran Suicide

NCT07286383 | Not Yet Recruiting Phase 3

• 3 other identifiers: HSR4-004-24WI01HX0039441I01RD000411-01A2
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 3

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

Keywords

suicide; peer support

Outcome Measures

Primary Outcomes (1)

• Computerized Adaptive Test- Suicide Scale; Columbia-Suicide Severity Rating Scale

  The primary outcome is the CAT-SS, which measures suicide risk severity on a 100- point scale with 5 points of precision (1= lowest, 100 = highest). The CAT-SS is an adaptive measure based on a bank of 111-items-i.e., an algorithm presents items (\~10 per subject) based on answers to previous items. The CAT-SS provides a crosswalk between suicidal ideation items and items that are drawn from domains of depression and anxiety that are strongly correlated with suicidal ideation (e.g., helplessness, hopelessness, anhedonia). Thus, it is a more general measure of suicide risk (vs. a measure of suicidal ideation specifically), does not depend on participants endorsing suicidal ideation to score in the high-risk range, nor does it suffer from floor effects like other traditional suicidal ideation measures (e.g., Beck Scale for Suicide Ideation).

  Baseline, 3 months, 6 months

Secondary Outcomes (7)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, 3 months, 6 months

• Quick Inventory of Depressive Symptoms (QIDS)

  Baseline, 3 months, 6 months

• Sheehan Disability Scale (SDS)

  Baseline, 3 months, 6 months

• Interpersonal Needs Questionnaire (INQ)

  Baseline, 3 months, 6 months

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Working Alliance Inventory (WAI).

  3 months, 6 months

Study Arms (2)

PREVAIL

EXPERIMENTAL

12 session, peer specialist delivered, suicide prevention program

Behavioral: PREVAIL

Usual Care

NO INTERVENTION

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

Interventions

PREVAIL BEHAVIORAL

12 session, peer specialist delivered, suicide prevention program

PREVAIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

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

Baltimore, Maryland, 21201, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Matthew J Chinman, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Chinman, PhD

CONTACT

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

Jessica R Dodge, PhD MSW MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Once Veterans are enrolled and complete the baseline assessment, research staff will open a sealed envelope containing the Veteran's random assignment to PREVAIL-VA or treatment as usual in a 1:1 ratio at each site. All randomized Veterans will be included in intent-to- treat analyses. Although Veterans and the PSs will know to which condition Veterans have been assigned, re- search assistants responsible for all assessments will be blinded to study group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: PREVAIL-VA is a 12-session, 3-month, semi-structured adjunctive suicide prevention program delivered by VA PSs (Peer Specialists). The content is flexible and allows for the PS to provide general supportive listening, validation, and sharing. Session duration is on average 1 hour with 15 to 45 minutes spent on a certain conversation topic. PREVAIL's framework was created to improve the consistency with which PSs delivered content related to hope, belongingness, and safety, and was retained in PREVAIL-VA. The first conversation consists of reviewing the Veteran's suicide safety plan. This is prioritized because if the Veteran is in crisis in a future session, the PS and Veteran will already have familiarized themselves with safety plan options. Subsequent ILSM conversations are determined by the PS based on the Veteran's needs and preferences (and adjusted based on supervision). While this flexibility allows for genuineness in the peer relationship.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy. The crosswalk between the analytical dataset(s) and the public release datasets will be maintained so that a VA-approved auditor or the PI could conduct or facilitate validation if needed. By sharing our data set, it will allow other investigators to independently confirm and validate our findings.
• Access Criteria: Investigators must demonstrate a clear rationale for how the data will be used.

Locations

US (3)