Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults

Suicidal Ideation Clinical Trial

— PREVAIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373916
• Other study ID #: HUM00137787
• Secondary ID: 1R01MH115111-01
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Inpatient Psychiatry Unit	Ann Arbor	Michigan
United States	Henry Ford Kingswood Hospital	Ferndale	Michigan
United States	Henry Ford Macomb Hospital	Mount Clemens	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression (measured by the Patient Health Questionnaire (PHQ-9))	Measure of the severity of depression	6-months
Other	Hope (measured by the Hope Scale (HS))	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-months
Other	Burdensomeness (measured by the Burdensomeness sub scale of the Interpersonal Needs Questionnaire (INQ))	Measures the interpersonal theory of suicide construct of burdensomeness	3-months
Other	Perceived Emotional Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))	Assessed via the ASRS emotional support scale (8 items)	3-months
Other	Perceived Instrumental Support (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))	Assessed via the ASRS instrumental support scale (8 items)	3-months
Other	Perceived Friendship (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))	Assessed via the ASRS friendship scale (8 items)	3-months
Other	Loneliness (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))	Assessed via the ASRS loneliness scale (5 items).	3-months
Other	Perceived Rejection (measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))	Assessed via the ASRS perceived rejection scale (8 items).	3-months
Other	Quality of Life (measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))	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.	6-months
Other	Functional Status (measured by the SF-12)	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.	]6-months
Other	Hopelessness (measured by the Beck Hopelessness Scale (BHS))	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.	3-months
Other	Perceived Social Support, (measured by 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. Mean scores under 2.9 are considered low support, mean scores 3-5 are considered moderate, and 5.1-7 are considered high.	3-months
Other	Self-reported utilization of health care services, as measured by the adapted Health Services Inventory	Collects data regarding health services used	6-months
Other	Medication adherence, as measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence	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.	6-months
Other	Perceived meaning in life, as measured by the Meaning in Life Questionnaire (MLQ)	10 items measured on a 7-point likert scale ranging from absolutely true to absolutely not true.	6-months
Other	Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))	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.	3-months
Other	Worst suicidal ideation in past 3 months (measured by the Beck Suicide Scale (BSS))	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.	6-months
Primary	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.	6-months
Primary	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.	6-months
Secondary	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.	6-months
Secondary	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.	6-months
Secondary	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.	6-months