Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults

NCT03373916 | Completed Results DMC

• 2 other identifiers: HUM001377871R01MH115111-01
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 3

Brief Summary

This is a single-blind, randomized controlled trial to test the effectiveness of a peer mentorship intervention (PREVAIL) for reducing suicide risk compared to enhanced usual care among participants (N=455) at high-risk for suicide recruited from inpatient psychiatric units.

Conditions

Suicidal Ideation

Keywords

Peer Mentorship; Psychiatric Hospitalization; Suicide Risk

Outcome Measures

Primary Outcomes (2)

• Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)

  Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S.

  3 months, 6 months

• Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS)

  Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk).

  3 months, 6 months

Secondary Outcomes (3)

• Suicide Attempts (Measured by the Medical Record)

  6-months

• Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale)

  3 months, 6 months

• Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS)

  3 months, 6 months

Other Outcomes (18)

• Depression, as Measured by the Patient Health Questionnaire (PHQ-9)

  3 months, 6 months

• Hope, as Measured by the State Hope Scale (SHS)

  3-months

• Burdensomeness, as Measured by the Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire (INQ-10)

  3-months

Study Arms (2)

Peer Mentorship intervention (PREVAIL)

EXPERIMENTAL

PREVAIL peer mentorship

Behavioral: Peer mentorship; Behavioral: Enhanced Usual Care

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Enhanced Usual Care

Behavioral: Enhanced Usual Care

Interventions

Peer mentorship BEHAVIORAL

The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness.

Also known as: PREVAIL

Peer Mentorship intervention (PREVAIL)

Enhanced Usual Care BEHAVIORAL

The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts.

Also known as: EUC

Enhanced Usual Care (EUC); Peer Mentorship intervention (PREVAIL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are age 18 years or older,
• are currently admitted to an inpatient psychiatric unit and have medical record documentation of suicidal ideation or suicide attempt at the time of admission,
• have a Beck Suicide Scale score of 5 or higher for the 1-week period prior to admission,
• are fluent in English,
• are able to be reached reliably by telephone.

You may not qualify if:

• substantially cognitively impaired (according to the Mini-Cog),
• unable to provide informed consent for any reason (including incompetency),
• determined by the patient's attending psychiatrist that peer mentorship is not appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder,
• already receiving or intending to receive peer mentorship (i.e., sponsor from Alcoholics Anonymous) or group-based peer support on a biweekly or more frequent basis,
• residing more than 50 miles from any peer mentor,
• planning to be discharged to another inpatient or residential facility, or
• receiving electroconvulsive therapy

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Michigan Inpatient Psychiatry Unit

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Kingswood Hospital

Ferndale, Michigan, 48220, United States

Location

Henry Ford Macomb Hospital

Mount Clemens, Michigan, 48043, United States

Location

Related Publications (2)

• Pfeiffer PN, Abraham KM, Lapidos A, Vega E, Jagusch J, Garlick J, Pasiak S, Ganoczy D, Kim HM, Ahmedani B, Ilgen M, King C. Peer Support Intervention for Suicide Prevention Among High-Risk Adults in Michigan: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510808. doi: 10.1001/jamanetworkopen.2025.10808.

  PMID: 40434775 DERIVED

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Paul Pfeiffer, MD
• Organization: University of Michigan

ppfeiffe@med.umich.edu

734-845-3645

Study Officials

• Paul Pfeiffer, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 14, 2017
• Study Start: June 22, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)