跳至主要内容
临床试验/NCT03373916
NCT03373916已完成不适用

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

University of Michigan6 个研究点 分布在 1 个国家目标入组 455 人开始时间: 2018年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
455
试验地点
6
主要终点
Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)

时间窗: 3 months, 6 months

Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S.

Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS)

时间窗: 3 months, 6 months

Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk).

次要结局

  • Suicide Attempts (Measured by the Medical Record)(6-months)
  • Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale)(3 months, 6 months)
  • Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS)(3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Pfeiffer

Associate Professor of Psychiatry

University of Michigan

研究点 (6)

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