Testing the Use of VA Peer Specialists to Prevent Veteran Suicide
ConditionSuicide Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
PREVAIL
Behavioral12 session, peer specialist delivered, suicide prevention program
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: PREVAILExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
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).
Time frame
Baseline, 3 months, 6 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsOther outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov