NCT07286383 · VA Office of Research and Development
Testing the Use of VA Peer Specialists to Prevent Veteran Suicide
(PREVAIL)
What this study is about
This study examines a novel way to prevent suicide among Veterans with serious mental illness (SMI). It will assess the effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
PREVAIL
12 session, peer specialist delivered, suicide prevention program
Primary outcome measures
Computerized Adaptive Test- Suicide Scale; Columbia-Suicide Severity Rating Scale
Time frame: Baseline, 3 months, 6 months
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
- Ann Arbor, Michigan
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations