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Completed

NCT Number: NCT03373916

Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Inpatient Psychiatry Unit, Ann Arbor, Michigan, United States

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About this study

Amid consistently worsening suicide rates, in 2012 the U.S. Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.

The aims of this hybrid effectiveness-implementation study are:

Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.

Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.

Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: 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.

Other names: EUC

Primary outcomes

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

    Time frame: 3 months, 6 months

    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.

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

    Time frame: 3 months, 6 months

    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).

Secondary outcomes

  1. Suicide Attempts (Measured by the Medical Record)

    Time frame: 6-months

    Count of participants with any suicide attempt as notated in the patient's electronic medical record. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt.

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

    Time frame: 3 months, 6 months

    Participants' sense of self-efficacy to avoid suicidal action, as measured by the 6-item Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 9-point scale (where 0=very uncertain and 9=very certain). Scores range between 0 and 54; lower scores are associated with worse outcomes (a higher incidence and greater severity of suicide attempts).

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

    Time frame: 3 months, 6 months

    Patient's worst-point 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).

Other outcomes

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

    Time frame: 3 months, 6 months

    The Patient Health Questionnaire (PHQ-9) is a 9-item, self-report survey which assesses frequency of depression symptoms over the past 2 weeks on a 4-item response scale (where 0 = "Not at all" and 3 = "Nearly every day"). Scores range between 0 and 27, with high scores indicating worse outcomes (more severe depression)

  2. Hope, as Measured by the State Hope Scale (SHS)

    Time frame: 3-months

    The State Hope Scale (SHS) is a 6-item, self-report measure that assesses hopeful thinking along two sub-scales reflecting respondents' personal capacity for change (agency) and knowledge regarding how to achieve change (pathways). Total scores range from 6 to 48. Higher scores indicated better outcomes (greater hope).

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

    Time frame: 3-months

    The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The perceived burdensomeness subscale of the INQ-10 consists of 4 items; scores range from 4 to 28, with higher scores indicating worse outcomes (greater perceived burdensomeness).

  4. Perceived Emotional Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))

    Time frame: 3-months

    The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Emotional Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived emotional support).

  5. Perceived Instrumental Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))

    Time frame: 3-months

    The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Instrumental Support subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived instrumental support).

  6. Perceived Friendship (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))

    Time frame: 3-months

    The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Friendship subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate better outcomes (greater perceived friendship).

  7. Loneliness (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))

    Time frame: 3-months

    The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The Loneliness subscale consists of 5 items rated on a 5-point Likert scale. Scores range from 5 to 25; higher scores indicate worse outcomes (greater loneliness).

  8. Perceived Rejection (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))

    Time frame: 3-months

    The Adult Toolbox Social Relationship Scales measures social relationship concepts including social support, companionship, and social distress. The perceived rejection subscale consists of 8 items rated on a 5-point Likert scale. Scores range from 8 to 40; higher scores indicate worse outcomes (greater loneliness).

  9. Quality of Life (Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))

    Time frame: 3 months, 6 months

    Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) consists of 14 items, assesses satisfaction with a variety of life domains such as physical health, work, and social relationships. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. Higher level of enjoyment and satisfaction with life are reflected in higher scores.

  10. Functional Status (Measured by the SF-12)

    Time frame: 3 months, 6 months

    The SF-12 covers domains including: (1) physical functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; and (8) mental health. Summary scores are calculated by summing factor-weighted scores across all 8 subscales, with factor weights derived from a US-based general population sample. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  11. Hopelessness (Measured by the Beck Hopelessness Scale (BHS))

    Time frame: 3-months

    Measure of patients' negative attitudes about the future and will be the primary measure of hopelessness. The BHS consists of 20 true-false statements that measure the degree of pessimism and negativity about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe.

  12. Perceived Social Support (Measured by the Multidimensional Scale of Perceived Social Support (MDPSS))

    Time frame: 3-months

    The Multidimensional Scale of Perceived Social Support (MDPSS) contains 12 Likert scale items with three subscales to address different sources of support: family, friends, and significant other. Total scores are an average (mean) of the subscale scores. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high. Scores range from 1-7, with 1 representing lowest support and 7 representing highest support.

  13. Self-reported Utilization of Health Care Services, as Measured by the Adapted Health Services Inventory

    Time frame: 3 months, 6 months

    Count of participants who self-reported utilizing any mental health care services.

  14. Medication Adherence, as Measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence

    Time frame: 3 months, 6 months

    Single item that ask patients' ability to take their medications as their doctor prescribed them, rated on a 6-point scale from 1 = "Excellent" to 6 = "Very Poor," such that higher scores indicate worse outcomes (poorer adherence with taking medications as prescribed).

  15. Perceived Meaning in Life, as Measured by the Meaning in Life Questionnaire (MLQ)

    Time frame: 3 months, 6 months

    The Meaning in Life Questionnaire (MLQ) consists of 10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true. The measure consists of two subscales: presence of meaning and search for meaning. Subscale scores range from 5 to 35; higher scores indicated better outcomes (greater meaning).

  16. Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS))

    Time frame: 3-months

    Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.

  17. Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS))

    Time frame: 6-months

    Patient's worst suicidal ideation in the previous 3-month time period as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items assess thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.

  18. Thwarted Belongingness, as Measured by the Thwarted Belongingness Subscale of the Interpersonal Needs Questionnaire (INQ-10)

    Time frame: 3-months

    The Interpersonal Needs Questionnaire (INQ-10) is a 10-item, self-report measure of perceived burdensomeness and thwarted belongingness. The thwarted belongingness subscale of the INQ-10 consists of 6 items; scores range from 5 to 35, with higher scores indicating worse outcomes (greater thwarted belongingness).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults

Acronym: PREVAIL

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2017
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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