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

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ClinicalTrials.gov Identifier: NCT03373916
Recruitment Status : Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Paul Pfeiffer, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Suicidal Ideation Behavioral: Peer mentorship Behavioral: Enhanced Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
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.
Behavioral: Peer mentorship
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 Name: PREVAIL

Active Comparator: Enhanced Usual Care
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.
Behavioral: Enhanced Usual Care
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 Measures :
  1. Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) [ Time Frame: 6-months ]
    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.

  2. Change in suicidal ideation (measured by the Beck Suicide Scale (BSS)) [ Time Frame: Baseline, 6-months ]
    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 :
  1. Suicide attempts (measured by the medical record) [ Time Frame: 6-months ]
    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.

  2. Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale) [ Time Frame: Baseline, 6-months ]
    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.


Other Outcome Measures:
  1. Change in Depression (measured by the PHQ-9) [ Time Frame: Baseline, 6-months ]
    Measure of the severity of depression

  2. Change in Hope (measured by the Hope Scale (HS)) [ Time Frame: Baseline, 3-months ]
    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.

  3. Change in Burdensomeness (measured by the Burdensomeness sub scale of the Interpersonal Needs Questionnaire (INQ)) [ Time Frame: Baseline, 3-months ]
    Measures the interpersonal theory of suicide construct of burdensomeness

  4. Change in perceived Emotional Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) [ Time Frame: Baseline, 3-months ]
    Assessed via the ASRS emotional support scale (8 items)

  5. Change in perceived Instrumental Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) [ Time Frame: Baseline, 3-months ]
    Assessed via the ASRS instrumental support scale (8 items)

  6. Change in perceived Friendship (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) [ Time Frame: Baseline, 3-months ]
    Assessed via the ASRS friendship scale (8 items)

  7. Change in Loneliness (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) [ Time Frame: Baseline, 3-months ]
    Assessed via the ASRS loneliness scale (5 items).

  8. Change in Perceived Rejection (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS)) [ Time Frame: Baseline, 3-months ]
    Assessed via the ASRS perceived rejection scale (8 items).

  9. Change in Quality of Life (measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)) [ Time Frame: Baseline, 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. Change in Functional Status (measured by the SF-12) [ Time Frame: Baseline, 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. Change in Hopelessness (measured by the Beck Hopelessness Scale (BHS)) [ Time Frame: Baseline, 6-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. Change in Perceived Social Support, (measured by the Multidimensional Scale of Perceived Social Support (MDPSS)) [ Time Frame: Baseline, 6-months ]
    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.

  13. Self-reported utilization of health care services, as measured by the adapted Health Services Inventory [ Time Frame: 6-months ]
    Collects data regarding health services used

  14. Medication adherence, as measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence [ Time Frame: 6-months ]
    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.

  15. Change in perceived meaning in life, as measured by the Meaning in Life Questionnaire (MLQ) [ Time Frame: Baseline, 6-months ]
    10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373916


Contacts
Contact: Paul Pfeiffer, MD 734-845-3645 ppfeiffe@umich.edu
Contact: Heather Walters, MS 734-845-3650 heawalte@umich.edu

Locations
United States, Michigan
University of Michigan Inpatient Psychiatry Unit Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Heather Walters, MS    734-845-3650    heawalte@umich.edu   
Principal Investigator: Paul Pfeiffer, MD         
Henry Ford Kingswood Hospital Not yet recruiting
Ferndale, Michigan, United States, 48220
Contact: Heather Walters, MS    734-845-3650    heawalte@umich.edu   
Principal Investigator: Brian Ahmedani, PhD         
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)

Responsible Party: Paul Pfeiffer, Associate Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03373916     History of Changes
Other Study ID Numbers: 1R01MH115111-01 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Pfeiffer, University of Michigan:
Peer Mentorship
Psychiatric Hospitalization
Suicide Risk

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms