跳至主要内容
临床试验/NCT05816317
NCT05816317已完成不适用

A Single-session Intervention for Suicidal Thoughts and Behaviors

Shannon E. Sauer-Zavala2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Change in intensity of suicidal ideation

研究概览

简要总结

Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up.

The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.

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
Double (Participant, 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
否

入选标准

  • •admitted for care to the Adult Inpatient Unit at Good Samaritan Hospital
  • •endorse suicidal ideation and/or a recent suicide attempt (i.e., "a potentially self-injurious act committed with at least some wish to die") upon intake to the unit
  • •18 years of age; (4) English speaking
  • •able to provide two methods for follow-up contact (i.e., phone number, email address) in order to complete study follow-up assessment.

排除标准

  • •current manic episode
  • •acutely psychotic
  • •actively detoxicating from substances
  • •the inability to comprehend the intervention

研究组 & 干预措施

Single-Session Mechanism Focused Intervention (SSMFI)

Experimental

干预措施: Single-Session Mechanism-Focused Intervention (SSMFI) (Behavioral)

Treatment as Usual

Active Comparator

干预措施: Distress Tolerance Skills Review (Behavioral)

结局指标

主要结局

Change in intensity of suicidal ideation

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)

Change in hopelessness

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)

Change in wish to live

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

I wish to live this much: (scale from "0" Not at all to "8" Very much)

Change in wish to die

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

I wish to die this much: (scale from "0" Not at all to "8" Very much)

Change in Beck Hopelessness Scale

时间窗: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Hopelessness will be measured with the Beck Hopelessness Scale. Scores range from 0-20 and higher scores indicate greater levels of hopelessness.

Change in Interpersonal Needs Questionnaire

时间窗: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Perceptions of social connectedness will be assessed with the Interpersonal Needs Questionnaire. Scores range from 0 to 107 with higher scores indicating less connection with others.

Change in intensity of suicidal ideation

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)

Change in wish to live

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

I wish to live this much: (scale from "0" Not at all to "8" Very much)

Change in Interpersonal Needs Questionnaire

时间窗: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Perceptions of social connectedness will be assessed with the Interpersonal Needs Questionnaire. Scores range from 0 to 107 with higher scores indicating less connection with others.

Change in hopelessness

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)

Change in Beck Hopelessness Scale

时间窗: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Hopelessness will be measured with the Beck Hopelessness Scale. Scores range from 0-20 and higher scores indicate greater levels of hopelessness.

Change in wish to die

时间窗: Pre-intervention and directly after the intervention (i.e., 1 hour later)

I wish to die this much: (scale from "0" Not at all to "8" Very much)

次要结局

  • Change in Columbia Suicide Severity Rating Scale(pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed)
  • Change in Adult Suicidal Ideation Questionnaire(pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed)

研究者

发起方
Shannon E. Sauer-Zavala
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shannon E. Sauer-Zavala

Associate Professor

University of Kentucky

研究点 (2)

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