跳至主要内容
临床试验/NCT05256940
NCT05256940进行中(未招募)不适用

Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2022年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
368
试验地点
3
主要终点
Columbia-Suicide Severity Rating Scale

研究概览

简要总结

The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.

详细描述

Research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. The PI developed a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) to help Veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. Enhanced usual care (EUC) for high-risk Veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. In a preliminary randomized controlled trial (RCT) in psychiatrically hospitalized Veterans, MI-SI-R plus EUC was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to EUC alone. The investigators are proposing an RCT comparing MI-SI-R plus EUC (MI-SI-R+EUC) to EUC alone in a sample of 470 high-risk Veterans with recent suicidal crises from three VHA Medical Centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation > 5 on the Beck Scale for Suicidal Ideation. Half (n = 235) will be randomized to MI-SI-R+EUC (three sessions in-person, via Video Connect, or telephone) and the remaining participants (n = 235) will receive EUC alone. All participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. This will allow the investigators to determine the efficacy of MI-SI-R+EUC in reducing risk for suicide attempts (Aim 1) and reducing overall suicidal ideation (Aim 2) when compared to EUC alone.

研究设计

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

盲法说明

Outcome assessors will be blinded to treatment received by participants.

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

  • Veteran status,
  • admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction,
  • age 18 and over,
  • English speaking and reading, and
  • ability to understand the study and provide informed consent,
  • high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score > 5 on the Scale for Suicidal Ideation

排除标准

  • current psychosis,
  • active mania,
  • dementia,
  • impaired decision making capacity, and
  • institutionalization due to hospitalization in a non-VA facility, jail, or prison.

研究组 & 干预措施

Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)

Experimental

Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone.

干预措施: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) (Behavioral)

Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)

Experimental

Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone.

干预措施: Enhanced usual care (EUC) (Other)

Enhanced usual care (EUC)

Active Comparator

Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.

干预措施: Enhanced usual care (EUC) (Other)

结局指标

主要结局

Columbia-Suicide Severity Rating Scale

时间窗: 12-months

The first primary outcome is the presence (vs. absence) of non-fatal suicide attempts as reported on the Columbia-Suicide Severity Rating Scale.

Beck Scale for Suicidal Ideation

时间窗: 12-month

The second primary outcome is suicidal ideation as reported on the Beck Scale for Suicidal Ideation, which has a range from 0-38, with higher scores indicating more severe suicidal ideation.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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