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Peer Based Suicide Prevention

Evaluating the Use of Peer Specialists to Support Suicide Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222673
Enrollment
17
Registered
2020-01-10
Start date
2021-05-14
Completion date
2024-03-30
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Suicide

Brief summary

Veterans Health Administration (VHA) suicide rates remain high, requiring new approaches. VHA patients tend to have high medical and behavioral health care needs that cause disruption in their lives and heighten their risk of suicide. This study will adapt and pilot test an intervention that expands the focus of care for VHA patients with high risk for suicide to building a life of self-respect, meaning, and connectedness in one's local community. The pilot intervention will involve receiving support and mentorship from a fellow Veteran living with the same challenges who has been trained in helping others manage their disabilities while achieving specific life goals (i.e., a 'Peer Specialist'). Results from this study will demonstrate the preliminary effectiveness of supplementing the VHA's current clinical approaches to suicide prevention with support provided by a trained Peer Specialist that offers empathy, hope, and practical advice that stemming from 'lived experience' of disability and recovery.

Detailed description

The investigators have assembled a team of clinical psychologists and researchers to use Intervention Mapping (IM) to adapt and test PREVAIL (a non VA, peer specialist based suicide prevention program) as a Peer Specialist (PS)-delivered intervention to reduce suicide ideation in VA patients who are at high risk of suicide. Building on the investigators' work with PSs, suicide research, and participatory methods, the investigators will begin the IM process with a needs assessment that includes interviews with PSs, VHA patients, providers, and directors (n=12) to assess attitudes and perceptions of current clinical practices for high risk Veterans, PSs, and areas of possible improvement in suicide prevention. This information will be shared with a steering committee to begin adapting PREVAIL to patients with high suicide risk in VHA. Following best practices for pilot investigations and intervention adaptation, the investigators will recruit 12 VHA patients with unipolar or bipolar depression flagged for high suicide risk to participate in a pre-pilot and provide feedback on how the adapted intervention may be revised. After making any necessary modifications to the intervention, the investigators will recruit a second group of 12 high risk Veterans for a formal pilot to further evaluate the feasibility and acceptability of recruitment, retention, and assessment procedures for a large randomized trial. Outcome variables will include health care visits for suicide-related reasons and self-reported suicidal ideation/acts as well as several outcomes that are rehabilitative in nature, such as self-rated community integration; sense of hope, meaning, and purpose; and self-esteem and social support. The investigators aim to: Aim 1: Use Intervention Mapping to identify which components of PREVAIL require adaptation to reduce suicidal ideation in high risk VHA patients and to identify implementation strategies in the VHA system; Aim 2: Pilot test the feasibility and acceptability of the adapted PREVAIL, rehabilitative measures, and suicide-related outcomes for use in a rigorous prospective study.

Interventions

BEHAVIORALPeer Specialist Suicide Prevention

The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The investigators will target Veterans with suicide flags because they are at greatest risk for suicide and therefore most in need of intervention * Eligibility will be limited to Veterans diagnosed with unipolar or bipolar depression as this diagnostic group is the most prevalent in suicidal samples and is supported by prior meta-analyses on peer-provided interventions * The investigators will ensure decision-making capacity using the Blessed Orientation, Memory, Concentration 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)

Exclusion criteria

* cognitive impairment as indicated by a Blessed score of \>10 * unable to provide voluntary, written informed consent for any reason * e.g., incompetency * determination by the patient's psychiatrist not to be appropriate for participation due to unstable psychosis, cognitive disorder, or severe personality disorder * residing more than 50 miles away

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire About the Process of Recovery (QPR) ChangeBaseline, post intervention (12 weeks)The Questionnaire about the Process of Recovery (QPR), contains 15 items that measure connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Range=0-60. High scores reflect greater connectedness, hope, positive identify, meaning, and empowerment.
Hearth Hope IndexBaseline, post intervention (12 weeks)a 12-item index shown to be reliable (a=.97) and valid, correlating with the Existential Well-Being Scale (r=.84) and the Hopelessness Scale (r=-.73). Scoring consists of summing the points for each item (ranges from 1 - least amount of hope to 4, indicating the most amount of hope) to make a total scale. Total possible points on the total scale is 48 points; the lowest is 12. The higher the score the higher the level of hope.
Suicide Cognitions Scale (SCS) ChangeBaseline, post intervention (12 weeks)The Suicide Cognitions Scale (SCS), contains18 items that assess thoughts of unlovability, unsolvability, and unbearability. The SCS has strong psychometric qualities in diverse samples (including Veterans) with incremental validity to predicting suicidal behavior beyond depression, INQ scores, prior attempts, and suicidal ideation. Range 18-90. Higher scores reflected greater sense of unlovability and inability to cope
Interpersonal Needs Questionnaire (INQ) Change - Perceived BurdenBaseline, post intervention (12 weeks)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 on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.
Interpersonal Needs Questionnaire (INQ) Change - Thwarted BelongingBaseline, post intervention (12 weeks)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 on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.
Quick Inventory of Depressive Symptoms (QIDS) ChangeBaseline, post intervention (12 weeks)To assess depression symptoms, the investigators will use the 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. Range=0-27. Higher scores represent increasing severity of depression.
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal IdeationBaseline, post intervention (12 weeks)Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) 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. Range= 0-10. Higher scores represent increasing presence of suicide-related behaviors and thoughts.
Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation IntensityBaseline, post intervention (12 weeks)Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) 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. Range= 0-25. Higher scores represent increasing presence of suicide-related behaviors and thoughts.

Countries

United States

Participant flow

Pre-assignment details

Given the nature of the subject matter (suicide), recruitment for the study was extremely challenging. Therefore, instead of having a pre-pilot and then a formal pilot, we collected data all at once in one pilot. That is why we are reporting the data all together in one group. Also, the 'needs assessment' process was simply informal qualitative discussions with various stakeholders that helped us adapt the programs to the VA. That is why the information is not reported here.

Participants by arm

ArmCount
Peer Specialist
The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future. Peer Specialist Suicide Prevention: The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future.
12
Total12

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up5

Baseline characteristics

CharacteristicPeer Specialist
Age, Continuous51.2 years
STANDARD_DEVIATION 17.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
6 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
6 Participants
Region of Enrollment
United States
12 Participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 17
other
Total, other adverse events
0 / 17
serious
Total, serious adverse events
0 / 17

Outcome results

Primary

Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation

Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) 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. Range= 0-10. Higher scores represent increasing presence of suicide-related behaviors and thoughts.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistColumbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal IdeationBaseline2.67 score on a scaleStandard Deviation 1.78
Peer SpecialistColumbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal IdeationPost1.08 score on a scaleStandard Deviation 0.99
Comparison: Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.p-value: 0.05the Reliable Change Index
Primary

Columbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation Intensity

Suicide measures will include the Columbia-Suicide Severity Rating Scale (C-SSRS) 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. Range= 0-25. Higher scores represent increasing presence of suicide-related behaviors and thoughts.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistColumbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation IntensityBaseline11.8 score on a scaleStandard Deviation 4.99
Peer SpecialistColumbia-Suicide Severity Rating Scale (C-SSRS) - Suicidal Ideation IntensityPost9.42 score on a scaleStandard Deviation 7.69
Comparison: Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.p-value: 0.05the Reliable Change Index
Primary

Hearth Hope Index

a 12-item index shown to be reliable (a=.97) and valid, correlating with the Existential Well-Being Scale (r=.84) and the Hopelessness Scale (r=-.73). Scoring consists of summing the points for each item (ranges from 1 - least amount of hope to 4, indicating the most amount of hope) to make a total scale. Total possible points on the total scale is 48 points; the lowest is 12. The higher the score the higher the level of hope.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistHearth Hope IndexBaseline27.5 score on a scaleStandard Deviation 6.84
Peer SpecialistHearth Hope IndexPost29.2 score on a scaleStandard Deviation 7.93
p-value: 0.05the Reliable Change Index
Primary

Interpersonal Needs Questionnaire (INQ) Change - Perceived Burden

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 on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistInterpersonal Needs Questionnaire (INQ) Change - Perceived BurdenBaseline20.7 score on a scaleStandard Deviation 9.56
Peer SpecialistInterpersonal Needs Questionnaire (INQ) Change - Perceived BurdenPost20.3 score on a scaleStandard Deviation 11.7
Comparison: Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.p-value: 0.05the Reliable Change Index
Primary

Interpersonal Needs Questionnaire (INQ) Change - Thwarted Belonging

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 on Veterans. Range 15-105. Higher scores associated with greater sense of perceived burden and thwarted belongingness.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistInterpersonal Needs Questionnaire (INQ) Change - Thwarted BelongingBaseline37.3 score on a scaleStandard Deviation 7.02
Peer SpecialistInterpersonal Needs Questionnaire (INQ) Change - Thwarted BelongingPost41.1 score on a scaleStandard Deviation 8.86
Comparison: Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.p-value: 0.05the Reliable Change Index
Primary

Questionnaire About the Process of Recovery (QPR) Change

The Questionnaire about the Process of Recovery (QPR), contains 15 items that measure connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Range=0-60. High scores reflect greater connectedness, hope, positive identify, meaning, and empowerment.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistQuestionnaire About the Process of Recovery (QPR) ChangeBaseline48.3 score on a scaleStandard Deviation 10.9
Peer SpecialistQuestionnaire About the Process of Recovery (QPR) ChangePost50.1 score on a scaleStandard Deviation 11.9
p-value: 0.05the Reliable Change Index
Primary

Quick Inventory of Depressive Symptoms (QIDS) Change

To assess depression symptoms, the investigators will use the 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. Range=0-27. Higher scores represent increasing severity of depression.

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistQuick Inventory of Depressive Symptoms (QIDS) ChangeBaseline19.4 score on a scaleStandard Deviation 8.51
Peer SpecialistQuick Inventory of Depressive Symptoms (QIDS) ChangePost17.3 score on a scaleStandard Deviation 8.34
p-value: 0.05the Reliable Change Index
Primary

Suicide Cognitions Scale (SCS) Change

The Suicide Cognitions Scale (SCS), contains18 items that assess thoughts of unlovability, unsolvability, and unbearability. The SCS has strong psychometric qualities in diverse samples (including Veterans) with incremental validity to predicting suicidal behavior beyond depression, INQ scores, prior attempts, and suicidal ideation. Range 18-90. Higher scores reflected greater sense of unlovability and inability to cope

Time frame: Baseline, post intervention (12 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
Peer SpecialistSuicide Cognitions Scale (SCS) ChangeBaseline38.8 score on a scaleStandard Deviation 7.78
Peer SpecialistSuicide Cognitions Scale (SCS) ChangePost36.3 score on a scaleStandard Deviation 11.2
Comparison: Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.p-value: 0.05the Reliable Change Index

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026