Peer Based Suicide Prevention

NCT ID: NCT04222673

Last Updated: 2025-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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Suicide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peer Specialist Suicide Prevention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J. Chinman, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

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

West Haven, Connecticut, United States

Site Status

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 37278930 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RX003291-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D3291-P

Identifier Type: -

Identifier Source: org_study_id

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