PREVAIL for Suicide

(PREVAIL Trial)

Not yet recruiting at 2 trial locations

Overseen By Matthew J Chinman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Acute psychosis, Dementia, Homicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent suicide among Veterans with serious mental health conditions. It features a 3-month program called PREVAIL, where Veterans meet individually with a Peer Specialist, who is also a Veteran and has faced similar mental health challenges. These sessions emphasize hope, belonging, support, and safety. The trial will compare this program to the usual care Veterans receive to determine which is more effective. Veterans at moderate to high risk for suicide recently and with current suicidal thoughts might be suitable candidates. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing additional support rather than changing existing treatments.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that the PREVAIL program, where veterans assist fellow veterans, is generally well-received. In one study, nearly half of the participants reported that PREVAIL helped reduce their suicidal thoughts or the likelihood of attempting suicide. This suggests the program is not only safe but may also lower the risk of suicide. Peer specialists, who are veterans themselves, use their experiences to support others, which other studies have shown to improve mental health. The available data contains no specific reports of negative effects from the PREVAIL program, supporting its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PREVAIL because it offers a fresh approach to suicide prevention by using a peer specialist-delivered program. Unlike traditional treatments that might involve medication or therapy with a clinician, PREVAIL focuses on a 12-session program led by individuals who have experienced similar challenges, providing a unique form of support and understanding. This peer-led method can create a more relatable and supportive environment for participants, potentially enhancing engagement and effectiveness in preventing suicide among veterans.

What evidence suggests that PREVAIL might be an effective treatment for suicide prevention in Veterans with serious mental illness?

Research has shown that peer support can help reduce suicidal thoughts. In this trial, participants may receive the PREVAIL program, which uses trained Peer Specialists with personal experience in mental illness to assist Veterans. In a previous study, about 48.5% of participants reported that the PREVAIL program positively affected their suicidal thoughts. This method shows promise in improving mental health by focusing on hope, belonging, and safety. Early findings suggest that these structured conversations can meaningfully support Veterans at risk for suicide. ^{1 2 6 7 8}

Who Is on the Research Team?

Matthew J. Chinman, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for Veterans with serious mental illness (SMI) who are at risk of suicide. Participants will engage in a 3-month program called PREVAIL-VA, which includes one-on-one sessions with Peer Specialists—Veterans trained to use their own recovery experiences to help others.

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

Current suicidal ideation according to the 9th item of the Patient health questionnaire (PHQ-9) > 0 at enrollment. A positive 9th item is required to ensure more recent suicidal ideation

Exclusion Criteria

I am able to understand and consent to participate in the study.

I am currently in or planning to enter a residential or intensive outpatient program.

Plan to transfer or terminate care in the next 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

PREVAIL-VA intervention consisting of 12 one-on-one sessions over 3 months between a Peer Specialist and a Veteran

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at baseline, post-intervention, and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• PREVAIL

Trial Overview

The study tests the effectiveness of PREVAIL-VA, involving 12 sessions aimed at fostering hope and safety. It compares this intervention against usual care provided to Veterans at risk for suicide, measuring its impact on preventing suicidal behaviors.

How Is the Trial Designed?

Group I: PREVAIL Experimental Treatment 1 Intervention

12 session, peer specialist delivered, suicide prevention program

Group II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12120652/

Peer Support Intervention for Suicide Prevention Among High ...

Among 132 participants interviewed, 64 (48.5%) indicated that PREVAIL had a positive impact on their suicidal ideation or likelihood of making a ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07286383

Testing the Use of VA Peer Specialists to Prevent Veteran ...

If PREVAIL-VA is effective, it could greatly increase the delivery of evidence-based services Veterans at risk for suicide receive and enhance ...

3.

power2u.org

power2u.org/wp-content/uploads/2021/03/Pfeiffer-2019-.pdf

Development and Pilot Study of a Suicide Prevention ...

The present study developed a peer specialist intervention (PREVAIL) to reduce suicide risk, incorporating components of motivational interviewing and ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ...

A primary care suicide prevention program supported by community public health resources, was effective in reducing suicide rates.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31078311/

Effectiveness of suicide prevention interventions

Conclusions: Suicide prevention interventions are effective in preventing completed and attempted suicides and should be widely implemented. Further research ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714419305658

Peer mentorship to reduce suicide attempts among high ...

The PREVAIL trial will demonstrate novel methods for incorporating peer providers into a suicide prevention effectiveness trial with high-risk study ...

7.

psychiatryonline.org

psychiatryonline.org/doi/full/10.1176/appi.pn.2022.10.10.31

Peer Specialists Can Aid in Suicide Prevention

During check-ins, the peers go over various suicide prevention strategies, such as reviewing the patients' safety plans, setting goals, and ...

8.

cectresourcelibrary.info

cectresourcelibrary.info/wp-content/uploads/2021/07/Bowersox-et-al_peer-based-interventions-targeting-suicide-1.pdf

Peer‐based interventions targeting suicide prevention

(2018) describe an intervention (PREVAIL) delivered by trained peers which provided support targeting suicide risk to patients discharged from inpatient ...