NCT04222673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 14, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 29, 2025

Completed
Last Updated

November 5, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

January 3, 2020

Results QC Date

January 15, 2025

Last Update Submit

October 16, 2025

Conditions

Keywords

Suicide

Outcome Measures

Primary Outcomes (8)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

  • 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.

    Baseline, post intervention (12 weeks)

Study Arms (1)

Peer Specialist

EXPERIMENTAL

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.

Behavioral: Peer Specialist Suicide Prevention

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Schmutte T, Krishnamurti LS, Davidson L, Klee A, Bullock J, Panas RM, Pfeiffer PN, Chinman M. Implementing Peer Specialists in Suicide Prevention Efforts in the Veterans Health Administration. Psychiatr Q. 2023 Jun;94(2):311-319. doi: 10.1007/s11126-023-10034-x. Epub 2023 Jun 6.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Matthew Chinman
Organization
Pittsburgh VA

Study Officials

  • Matthew J. Chinman, PhD

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 10, 2020

Study Start

May 14, 2021

Primary Completion

December 30, 2023

Study Completion

March 30, 2024

Last Updated

November 5, 2025

Results First Posted

April 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations