search
Back to results

Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults (PREVAIL)

Primary Purpose

Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer mentorship
Enhanced Usual Care
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Peer Mentorship, Psychiatric Hospitalization, Suicide Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. substantially cognitively impaired (according to the Mini-Cog),
  2. unable to provide informed consent for any reason (including incompetency),
  3. determined by the patient's attending psychiatrist that peer mentorship is not appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder,
  4. 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,
  5. residing more than 50 miles from any peer mentor,
  6. planning to be discharged to another inpatient or residential facility, or
  7. receiving electroconvulsive therapy

Sites / Locations

  • University of Michigan Inpatient Psychiatry Unit
  • Henry Ford Kingswood Hospital
  • Henry Ford Macomb Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer Mentorship intervention

Enhanced Usual Care (EUC)

Arm Description

A Peer Specialist will be making weekly follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge. The content of the peer mentorship interactions will be based on the manual developed by the study team and will address protective factors such as hope and belongingness.

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.

Outcomes

Primary Outcome Measures

Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Any suicide attempt as measured according to an electronic self-report version of the Columbia Suicide Severity Rating Scale (CSSR-S). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.
Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Patient's current suicidal ideation 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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.

Secondary Outcome Measures

Suicide attempts (measured by the medical record)
Any suicide attempt as notated in the patients 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.
Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale)
Patient's self efficacy to avoid suicidal action, as measured by the Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 6-point scale (0%, 20%, 40%, 60%, 80%, 100%). Lower scores on the SEASA were found to be associated with a higher incidence and greater severity of suicide attempts.
Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Patient's worst-point suicidal ideation 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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.

Full Information

First Posted
November 28, 2017
Last Updated
October 3, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT03373916
Brief Title
Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults
Acronym
PREVAIL
Official Title
Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Peer Mentorship, Psychiatric Hospitalization, Suicide Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Mentorship intervention
Arm Type
Experimental
Arm Description
A Peer Specialist will be making weekly follow-up contact with study participants in the community or by telephone for 3 months following hospital discharge. The content of the peer mentorship interactions will be based on the manual developed by the study team and will address protective factors such as hope and belongingness.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer mentorship
Other Intervention Name(s)
PREVAIL
Intervention Description
The peer mentor will meet with the participant for the first time while the participant is still in the hospital. Sessions will be scheduled according to the participant's preferences, with a suggested maximum frequency of twice weekly for the first two weeks, weekly for weeks 3 to 8, and then every other week for the last month. Allowable meeting locations include public places in the community (e.g., coffee shop, park), the participant's home, or a research clinic space or by phone. Session content is flexible and allows for the peer mentor to provide general supportive listening, validation, and sharing. Session duration is on average 1 hour with at least 15 minutes discussing hope or belongingness according to semi-structured conversation guides. The session structure and content are intentionally highly flexible to allow for genuineness in the peer relationship, thereby increasing acceptability and implicit belongingness.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Description
Any suicide attempt as measured according to an electronic self-report version of the Columbia Suicide Severity Rating Scale (CSSR-S). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.
Time Frame
6-months
Title
Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Description
Patient's current suicidal ideation 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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Suicide attempts (measured by the medical record)
Description
Any suicide attempt as notated in the patients 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.
Time Frame
6-months
Title
Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale)
Description
Patient's self efficacy to avoid suicidal action, as measured by the Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 6-point scale (0%, 20%, 40%, 60%, 80%, 100%). Lower scores on the SEASA were found to be associated with a higher incidence and greater severity of suicide attempts.
Time Frame
6-months
Title
Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Description
Patient's worst-point suicidal ideation 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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.
Time Frame
6-months
Other Pre-specified Outcome Measures:
Title
Depression (measured by the Patient Health Questionnaire (PHQ-9))
Description
Measure of the severity of depression
Time Frame
6-months
Title
Hope (measured by the Hope Scale (HS))
Description
A 12-item measure that contains two sub-scales reflecting respondents' personal capacity for change (agency) and knowledge regarding how to achieve change (pathways). The HS has been associated with positive coping strategies and was sensitive to improvement among participants of a peer-led group illness management intervention.
Time Frame
3-months
Title
Burdensomeness (measured by the Burdensomeness sub scale of the Interpersonal Needs Questionnaire (INQ))
Description
Measures the interpersonal theory of suicide construct of burdensomeness
Time Frame
3-months
Title
Perceived Emotional Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Description
Assessed via the ASRS emotional support scale (8 items)
Time Frame
3-months
Title
Perceived Instrumental Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Description
Assessed via the ASRS instrumental support scale (8 items)
Time Frame
3-months
Title
Perceived Friendship (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Description
Assessed via the ASRS friendship scale (8 items)
Time Frame
3-months
Title
Loneliness (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Description
Assessed via the ASRS loneliness scale (5 items).
Time Frame
3-months
Title
Perceived Rejection (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Description
Assessed via the ASRS perceived rejection scale (8 items).
Time Frame
3-months
Title
Quality of Life (measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))
Description
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.
Time Frame
6-months
Title
Functional Status (measured by the SF-12)
Description
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.
Time Frame
]6-months
Title
Hopelessness (measured by the Beck Hopelessness Scale (BHS))
Description
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.
Time Frame
3-months
Title
Perceived Social Support, (measured by the Multidimensional Scale of Perceived Social Support (MDPSS))
Description
Contains 12 likert scale items with three subscales to address different sources of support: family, friends, and significant other. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high.
Time Frame
3-months
Title
Self-reported utilization of health care services, as measured by the adapted Health Services Inventory
Description
Collects data regarding health services used
Time Frame
6-months
Title
Medication adherence, as measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence
Description
Single item that ask patients' ability to take their medications as their doctor prescribed them, rated on a 6-point scale from excellent to very poor.
Time Frame
6-months
Title
Perceived meaning in life, as measured by the Meaning in Life Questionnaire (MLQ)
Description
10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true.
Time Frame
6-months
Title
Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))
Description
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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.
Time Frame
3-months
Title
Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))
Description
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 48 (if the screening items are included). No specific cut-off scores exist to classify severity. Increasing scores reflect greater suicide risk.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pfeiffer, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Inpatient Psychiatry Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Kingswood Hospital
City
Ferndale
State/Province
Michigan
ZIP/Postal Code
48220
Country
United States
Facility Name
Henry Ford Macomb Hospital
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived

Learn more about this trial

Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults

We'll reach out to this number within 24 hrs