Clinical trial NCT03373916: Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults
Official title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Keywords: Peer Mentorship
Psychiatric Hospitalization
Suicide Risk
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-12-14
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: 3 months, 6 months
measure: Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS)
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Suicide Attempts (Measured by the Medical Record)
timeFrame: 6-months
measure: Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale)
timeFrame: 3 months, 6 months
measure: Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS)
timeFrame: 3 months, 6 months
Other outcomes:
measure: Depression, as Measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months, 6 months
measure: Hope, as Measured by the State Hope Scale (SHS)
timeFrame: 3-months
measure: Burdensomeness, as Measured by the Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire (INQ-10)
timeFrame: 3-months
measure: Perceived Emotional Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
timeFrame: 3-months
measure: Perceived Instrumental Support (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
timeFrame: 3-months
measure: Perceived Friendship (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
timeFrame: 3-months
measure: Loneliness (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
timeFrame: 3-months
measure: Perceived Rejection (Measured by the NIH Toolbox Adult Social Relationship Scales (ASRS))
timeFrame: 3-months
measure: Quality of Life (Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF))
timeFrame: 3 months, 6 months
measure: Functional Status (Measured by the SF-12)
timeFrame: 3 months, 6 months
measure: Hopelessness (Measured by the Beck Hopelessness Scale (BHS))
timeFrame: 3-months
measure: Perceived Social Support (Measured by the Multidimensional Scale of Perceived Social Support (MDPSS))
timeFrame: 3-months
measure: Self-reported Utilization of Health Care Services, as Measured by the Adapted Health Services Inventory
timeFrame: 3 months, 6 months
measure: Medication Adherence, as Measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence
timeFrame: 3 months, 6 months
measure: Perceived Meaning in Life, as Measured by the Meaning in Life Questionnaire (MLQ)
timeFrame: 3 months, 6 months
measure: Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS))
timeFrame: 3-months
measure: Worst Suicidal Ideation in Past 3 Months (Measured by the Beck Suicide Scale (BSS))
timeFrame: 6-months
measure: Thwarted Belongingness, as Measured by the Thwarted Belongingness Subscale of the Interpersonal Needs Questionnaire (INQ-10)
timeFrame: 3-months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Inpatient Psychiatry Unit
state: Michigan
city: Ferndale
country: United States
facility: Henry Ford Kingswood Hospital
state: Michigan
city: Mount Clemens
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.