- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373916
Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults (PREVAIL)
Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Inpatient Psychiatry Unit
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Ferndale, Michigan, United States, 48220
- Henry Ford Kingswood Hospital
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Mount Clemens, Michigan, United States, 48043
- Henry Ford Macomb Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Peer Mentorship intervention
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.
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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.
Other Names:
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Active Comparator: Enhanced Usual Care (EUC)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide attempts (measured by the Columbia Suicide Severity Rating Scale)
Time Frame: 6-months
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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.
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6-months
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Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Time Frame: 6-months
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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.
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6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide attempts (measured by the medical record)
Time Frame: 6-months
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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.
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6-months
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Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale)
Time Frame: 6-months
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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.
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6-months
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Suicidal ideation (measured by the Beck Suicide Scale (BSS))
Time Frame: 6-months
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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.
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6-months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression (measured by the Patient Health Questionnaire (PHQ-9))
Time Frame: 6-months
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Measure of the severity of depression
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6-months
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Hope (measured by the Hope Scale (HS))
Time Frame: 3-months
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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.
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3-months
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Burdensomeness (measured by the Burdensomeness sub scale of the Interpersonal Needs Questionnaire (INQ))
Time Frame: 3-months
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Measures the interpersonal theory of suicide construct of burdensomeness
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3-months
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Perceived Emotional Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Time Frame: 3-months
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Assessed via the ASRS emotional support scale (8 items)
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3-months
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Perceived Instrumental Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Time Frame: 3-months
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Assessed via the ASRS instrumental support scale (8 items)
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3-months
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Perceived Friendship (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Time Frame: 3-months
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Assessed via the ASRS friendship scale (8 items)
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3-months
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Loneliness (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Time Frame: 3-months
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Assessed via the ASRS loneliness scale (5 items).
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3-months
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Perceived Rejection (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
Time Frame: 3-months
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Assessed via the ASRS perceived rejection scale (8 items).
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3-months
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Quality of Life (measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))
Time Frame: 6-months
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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.
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6-months
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Functional Status (measured by the SF-12)
Time Frame: ]6-months
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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.
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]6-months
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Hopelessness (measured by the Beck Hopelessness Scale (BHS))
Time Frame: 3-months
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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.
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3-months
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Perceived Social Support, (measured by the Multidimensional Scale of Perceived Social Support (MDPSS))
Time Frame: 3-months
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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.
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3-months
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Self-reported utilization of health care services, as measured by the adapted Health Services Inventory
Time Frame: 6-months
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Collects data regarding health services used
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6-months
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Medication adherence, as measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence
Time Frame: 6-months
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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.
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6-months
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Perceived meaning in life, as measured by the Meaning in Life Questionnaire (MLQ)
Time Frame: 6-months
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10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true.
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6-months
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Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))
Time Frame: 3-months
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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.
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3-months
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Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))
Time Frame: 6-months
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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.
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6-months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Pfeiffer, MD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00137787
- 1R01MH115111-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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