An interventional study of PREVAIL in Suicide Risk, sponsored by VA Office of Research and Development. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
BACKGROUND: Suicide is a top priority for the VA, claiming about 6,000 Veterans each year. VA suicide services primarily focus on immediate response to increased suicide risk but lack a focus on recovery, conceptualized by VHA as an internal process of hope, healing, empowerment, and social reconnection. The lack of a recovery focus in suicide prevention is a gap in VHA care quality. VHA Peer Specialists (PSs)-Veterans with serious mental illness (SMI) who are trained to use their experience to help other Veterans with SMI as full-fledged employees (\~1,400 VA-wide)-could improve the quality of suicide prevention by making these services more recovery oriented. Based on multiple studies showing that PSs improve a range of outcomes for Veterans with SMI, the VA National Strategy for Preventing Veteran Suicide calls for the development of peer-to-peer services to help those at risk for suicide for their ability to "impart hope and motivation for achieving recovery; provide support for addressing specific stressors, and help foster a sense of meaning and purpose."
SIGNIFICANCE: Administrative data shows that VHA PSs are already working with Veterans at risk for suicide. If PREVAIL-VA is effective, it could greatly increase the delivery of evidence-based services Veterans at risk for suicide receive and enhance the services by VHA Peer Specialists.
INNOVATION: No study has tested a PS-delivered suicide prevention service in the VHA in a rigorous trial.
SPECIFIC AIMS: The proposed study is a Hybrid Type 1 randomized trial with two aims: Aim 1: Deliver PREVAIL-VA and compare recipients of PREVAIL-VA and Usual Care on suicide-related and recovery outcomes. Aim 2: Collect qualitative data on PREVAIL-VA helpfulness, and implementation barriers and facilitators using the Consolidated Framework for Implementation Research (CFIR) and rapid qualitative analysis.
METHODS: This application proposes to test in two VA health systems-Pittsburgh and Maryland-a promising PS-based approach to helping VA patients with a high risk of suicide, called PREVAIL-VA. Adapted from a civilian version with VA PS and suicide stakeholder input, PREVAIL-VA (Peers for Valued Living) provides 12, one-on-one sessions over about three months between a PS and a Veteran that involve semi-structured conversations focused on hope, belongingness, and safety. Session context is flexible, driven by the needs of the individual and by the ILSM (Invite, Learn, Share, Motivate) structure that guides how PSs interact with those whom they work. A civilian pilot study was promising; preliminary findings of a larger civilian trial showed small improvements. Veterans with documented suicide risk at each site (n=153) will be randomized to PREVAIL-VA or Usual Care (total N=306). Each site will have two trained PSs, who will each deliver PREVAIL-VA to \~40 Veterans over \~3 years (\~4 Veterans at any one time). PSs will be trained and receive an hour of group supervision weekly by the PREVAIL-VA developer and licensed psychologists, who will also be available for emergencies. Sessions will be taped and 15% rated for fidelity on standardized measures. Each Veteran will be assessed at baseline, post-intervention, and six months post-intervention on the primary outcome of suicide risk with additional primary outcomes focusing on recovery domains such as self-rated community integration; sense of hope, meaning, and purpose. Secondary outcomes will include suicide attempts, depression, belonging, and acute care visits for suicide-related reasons. The primary analytic strategy will be a generalized mixed-effect model approach including intervention group, time, and time by group interaction terms. Relevant covariates will include site, fidelity ratings, treatment attendance, VA service use, and demographic variables. At each site, all PSs and a subset of PREVAIL-VA Veterans, VHA clinicians whose patients received PREVAIL-VA, and clinical leaders will participate in qualitative data collection (periodic reflection, interview, focus group) about helpfulness of PREVAIL-VA and relevant CFIR-based implementation factors that could inform its future adoption. Qualitative data will be analyzed with a 'rapid analysis' approach.
NEXT STEPS/Implementation: If effective, the investigators will develop an implementation toolkit and work with partners to teach PREVAIL-VA to all PSs.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's planned enrollment of 306 is above the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
There are two Inclusion criteria:
Moderate to high suicide risk according to one of the following occurring in the prior 3 months:
AND
Current suicidal ideation according to the 9th item of the Patient health questionnaire (PHQ-9) > 0 at enrollment
Exclusion Criteria:
Inability to provide for any reason, including due to acute psychosis or mania, dementia, or active guardianship or durable power of attorney
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 session, peer specialist delivered, suicide prevention program
Behavioral: PREVAIL
Veterans assigned to this group will receive additional monitoring but no active intervention.
12 session, peer specialist delivered, suicide prevention program
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).
Time frame: Baseline, 3 months, 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal ideation (past 30 days) and behaviors (past 3 months). Suicide ideation items include: (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) suicidal thoughts with methods, (4) suicidal intent, and (5) suicidal intent with plan. The suicidal behavior subscales include: (1) attempts (actual, aborted, interrupted), (2) preparatory behavior, and (3) non-suicidal self-injurious behavior. The investigators will also use two measures of psychosocial variables that potentially mediate suicide risk and are hypothesized to be impacted by PSs.
Time frame: Baseline, 3 months, 6 months
Quick Inventory of Depressive Symptoms (QIDS)
Quick Inventory of Depressive Symptoms (QIDS) which consists of 16 questions to assess depression severity. The QIDS has demonstrated high reliability, validity, and sensitivity to treatment change, including among Veterans.
Time frame: Baseline, 3 months, 6 months
Sheehan Disability Scale (SDS)
Sheehan Disability Scale (SDS) uses 3 items to measure how much work, social life, and family life are impaired by mental health symptoms.
Time frame: Baseline, 3 months, 6 months
Interpersonal Needs Questionnaire (INQ)
The Interpersonal Needs Questionnaire (INQ) uses 15 items to measure two underlying motives for suicidal desire (i.e., perceived burden and thwarted belonging). The INQ has established validity and reliability, including with Veterans.
Time frame: Baseline, 3 months, 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal ideation (past 30 days) and behaviors (past 3 months). Suicide ideation items include: (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) suicidal thoughts with methods, (4) suicidal intent, and (5) suicidal intent with plan. The suicidal behavior subscales include: (1) attempts (actual, aborted, interrupted), (2) preparatory behavior, and (3) non-suicidal self-injurious behavior.
Time frame: Baseline, 3 months, 6 months
Suicide Cognitions Scale (SCS)
The Suicide Cognitions Scale (SCS) contains 18 items that assess thoughts of unlovability, unsolvability, and unbearability.
Time frame: Baseline, 3 months, 6 months
Herth Hope Index (HHI)
The Herth Hope Index (HHI) is a 12-item self-report measure designed to assess hope in adults experiencing acute, chronic, or terminal illness. The Herth Hope Index (HHI) yields a total score ranging from 12 to 84, with higher scores indicating greater levels of hope, as well as three subscale scores ranging from 4 to 28: Sense of temporality and future (Items 1, 2, 6 \[reverse-scored\], and 11): Higher score indicate stronger future orientation and goal-directed thinking. Positive readiness and expectancy (Items 4, 7, 10, and 12): Higher scores suggest greater emotional resilience and readiness to act on hope. Interconnectedness with self and others (Items 3 \[reverse-scored\], 5, 8, and 9): Higher scores indicate stronger interpersonal connections and beliefs that sustain hope.
Time frame: Baseline, 3 months, 6 months
Working Alliance Inventory (WAI).
The WAI is a widely used measure of therapeutic alliance in various healthcare settings, including psychotherapy, physiotherapy, and general practice. Research has shown that a strong working alliance is associated with positive outcomes, including improved adherence, satisfaction, and treatment effectiveness.
Time frame: 3 months, 6 months
Not enrolling at this site.
Plan to share: Yes — The PI will create de-identified, study-specific datasets. All variables presented in a publication will be included in the dataset. Some loss of information might occur in this process given the need to remove PHI. The PI will replace social security and medical station numbers with study-specific numbers. The PI will drop date of birth and replace age with age categories, per PHI requirements for people 85+years of age. Service dates will be replaced with study specific time indicators.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
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